Source: https://www.global-regulation.com/translation/belgium/3031548/miscellaneous-provisions-act-health.html
Timestamp: 2018-08-15 11:31:01
Document Index: 20553311

Matched Legal Cases: ['§ 9', '§ 9', 'art. 4', '§ 3', '§ 1', '§ 1', '§ 1', 'arts 10', '§ 1', '§ 3', '§ 3', '§ 1', '§ 2', 'art. 16', 'art. 17', '§ 1', '§ 8', '§ 8', 'art.\n19', '§ 1', '§ 1', 'art.\n23', '§ 2', '§ 4', 'art.\n26', '§ 1', '§ 4', '§ 5', '§ 1', '§ 2', '§ 9', '§ 9', '§ 11', '§ 8', '§ 2', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', 'art. 37', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 2', '§ 3', '§ 1', '§ 10', '§ 10', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', 'art. 64', '§ 2', '§ 1', 'art.\n71', '§ 3', '§ 3', 'art. 73', 'art.\n76', 'art. 77', '§ 1', '§ 2', '§ 3', '§ 2', '§ 1', '§ 1', '§ 2', '§ 1', '§ 2', '§ 1', '§ 1', '§ 3', '§ 1', '§ 1', '§ 2', '§ 2', '§ 3', '§ 8', 'art. 92', '§ 1', '§ 1', '§ 1', '§ 3', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', 'Art. 96', '§ 1', '§ 1', '§ 1', '§ 5', '§ 1', '§ 2', '§ 1', '§ 2', 'art. 110', '§ 3', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 2', '§ 4', '§ 1', '§ 1', '§ 4', '§ 7', '§ 14', '§ 14', '§ 3', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 13', '§ 2', '§ 1', '§ 1', '§ 1', '§ 2', '§ 3', '§ 1', '§ 1', 'art.\n129', '§ 1', '§ 1', '§ 7', '§ 7', '§ 1', '§ 3', '§ 1', '§ 1', '§ 2', '§ 1', '§ 3', '§ 1', '§ 1', '§ 1', '§ 2', '§ 1', '§ 3', '§ 4', '§ 1', '§ 1', '§ 1', '§ 1', '§ 2', '§ 1', '§ 1', '§ 1', '§ 2', '§ 1', '§ 1', '§ 1', '§ 2', '§ 1', '§ 3', '§ 4', '§ 1', '§ 3', '§ 3', '§ 4', '§ 4', '§ 6', '§ 1', '§ 1', '§ 1', '§ 7', '§ 7', '§ 1', '§ 4', '§ 4', '§ 2', '§ 2', '§ 1', '§ 2', '§ 3', '§ 1', '§ 1', '§ 2', '§ 2', '§ 3', '§ 4', '§ 2', 'art. 155', 'art. 156', '§ 2', '§ 1', 'art. 158', '§ 2', '§ 2', '§ 1', '§ 1', '§ 1', '§ 1', '§ 3', '§ 2', '§ 2', '§ 4', '§ 2', '§ 2', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 2', '§ 2', '§ 1', '§ 1', '§ 2', '§ 1', '§ 1', 'art. 168', 'art.\n169', '§ 1', 'art. 173', '§ 2', 'art. 174', '§ 2', 'art. 177', '§ 2', '§ 2', '§ 3', '§ 5', '§ 1', '§ 1', '§ 2', '§ 2', '§ 4', '§ 1', 'art. 196']

Read the untranslated law here: http://www.ejustice.just.fgov.be/cgi/article_body.pl?numac=2014024167&caller=list&article_lang=F&row_id=700νmero=796&pub_date=2014-04-30&dt=LOI〈uage=fr&fr=f&choix1=ET&choix2=ET&fromtab=+moftxt&trier=publication&sql=dt+=+'LOI'&tri=pd+AS+RANK+
Posted the: 2014-04-30 Numac: 2014024167 PUBLIC SERVICE FEDERAL public health, food chain safety and environment April 10, 2014. -Law on miscellaneous provisions health PHILIPPE, King of the Belgians, to all, present and to come, hi.
The Chambers have adopted and we endorse the following: title 1. -INTRODUCTORY provision Article 1.
TITLE 2. -INAMI Chapter 1. Insurance compulsory health care and allowances Section 1.
-Cooperation administrative s. 2. in article 191, paragraph 2, of the law on compulsory health care and benefits insurance, co-ordinated on 14 July 1994, inserted by the law of January 25, 1999 and amended by the Act of 27 December 2006, the following changes are made: 1 ° the words "Code of similar fees to the stamp" are replaced by the words "Code of duties and taxes various";
2 ° the same paragraph is supplemented by the following sentence: "in order to provide the information necessary for the collection of these additional contributions or premiums, these income and deductions, the Institute may appeal to administrative cooperation in tax matters, between the Belgium and other States members of the Union European, as referred to in article 211a of the Code of rights and various taxes.".
Section 2. -Financing of the rare diseases and orphan drugs s. Fund 3. article 56 of the Act, as last amended by the Act of 26 December 2013, is complemented by a § 9, as follows: "§ § 9 9" The Institute grants a financial single intervention of 15,000 euros to the King Baudouin Foundation, to fund the Mission granted to the Fund rare diseases and orphan in the context of the conference organized as part of EUROPLAN 2012-2015, Belgian for rare diseases with Orphanet. The intervention is charged fully to the 2014 health care budget."
Section 3. -Composition of national College of medical consultants and colleges premises art. 4. in article 153, § 3, paragraph 5, of the Act, inserted by the law of December 19, 2008, the words "or physical therapists" are inserted between the words "nursing practitioners 'and the words', instructed by medical officers of insurers.".
Section 4. -Council on accreditation s. 5. in article 215, § 1, of the Act, amended by the acts of 24 December 1999 and March 19, 2013, the words ", 4 ° bis and 7 bis" are replaced by the words "and 4 ° bis".
Section 5. -Benefits of logopedists s. 6. in the heading of title III, chapter V, section IV, of the Act, the words ", and speech therapists" are inserted between the words "pharmacists" and the words "and physiotherapists".
S. 7. in article 54, § 1, paragraph 1, of the Act, replaced by the Act of 22 December 2003, the words ", the convention Committee to negotiate and conclude the national convention between the therapists and insurers" shall be inserted between the words "of the Permanent Commission to negotiate and conclude the national convention between pharmacists and insurers" and the words "or the convention Commission responsible for negotiating and" conclusion the national convention between physiotherapists and insurers ".
In the same paragraph, the words ", the therapists' shall be inserted between the words"or for pharmacists"and the words" or physiotherapists who Member ".
S. 8. in article 54, § 1, paragraph 3, of the Act, replaced by the Act of 22 December 2003 and amended by the law of December 19, 2008, the words ", the speech therapists" are inserted between the words "pharmacists" and the words "and physiotherapists".
S. 9. in article 54, paragraph 2, of the Act, replaced by the Act of 22 December 2003, the following changes are made: 1 ° in the paragraph 1, the word ", speech therapists' is inserted between the word"pharmacists"and the words"and physiotherapists".
2 ° in paragraph 3, the word ", speech therapists' is inserted between the word"pharmacists"and the words"and physiotherapists".
Section 6. -Cash relief and social security for seafarers and Safety Office of overseas arts 10. article 53, § 1, of the Act, as last amended by the Act of March 19, 2013, is supplemented by a paragraph as follows: "The King specifies detailed rules for the application of the obligation of payment referred to in clause 13 by the Fund relief and welfare for the sailors and the overseas social security Office."
Section 7. -Internal arts. 11. article 56, § 3, paragraph 1, of the Act, inserted by the law of 27 December 2004 and amended by the Act of 11 July 2005, is supplemented by the following sentences: "the amount of 27.659 thousand euros is adapted from 2006 to the evolution of the average arithmetic of the health index in the month of June and indices of the previous three months between June 30 of last year and June 30 of the year that has" preceded. In 2013, the amount of this support amounts up to 34.522 thousand euros. "From 2014, this amount will be adapted to the evolution of the average arithmetic of the health index in the month of June and indices of the previous three months between June 30 of last year and June 30 of the year preceding."
S. 12. in article 56, § 3A, paragraph 3, of the Act, inserted by the law of 27 December 2005, the words "referred to in §§ 1 and 2" shall be replaced by the words "referred to in paragraphs 1 and 2".
-Pathology s. 13. in the same law, the heading of title III, chapter V, section VIII, is replaced by the following: "Section VIII. -Clinical biology and pathology services provided to beneficiaries hospitalized and no hospitalized."
S. 14A article 59, paragraph 1, of the Act, replaced by the law of December 23, 2009, the following changes are made: 1 ° the words "and the overall budget of the financial means for the whole of the Kingdom for the benefit of pathology as laid down by the general Council" shall be inserted between the words "as set out by the general Council" and the words "as well as";
2 ° "budget" shall be replaced by the words "these budgets".
S. 15. article 67, § 2, of the Act, inserted by the law of 24 December 1999, is supplemented by the words "and article 65".
Section 9. -Conclusion of agreements with the Scientific Institute of health public art. 16. article 22 of the Act, as last amended by the law of December 15, 2013, is complemented by the 20 ° as follows: "(20° conclut avec l'Institut scientifique de Santé publique-WIV-ISP une convention de collaboration chaque fois qu'il entend lui confier une mission: a) to create and use databases to increase knowledge of the health of the population in order to increase epidemiological knowledge" clinical and other. For these purposes, the Scientific Institute of public health - WIV - ISP is responsible: (1) develop technical platforms to collect data, use of existing databases, possibly via coupling, using the services of an organization, such as defined in article 1, 6 °, of the royal decree of 13 February 2001 on the implementation of the law of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data;
2 ° coordinating and supporting the harvest data;
3 ° to validate and analyze the data collected;
4 ° to prepare comprehensive reports on the information collected;
5 ° to prepare evaluation reports on the parameters of reference for those who participated in the collection of data;
6 ° to develop scientific research to improve public health policy, the health care and health care policy.
(b) in the view, in the context of references to human microbiology centres: 1 ° to ensure the diagnosis of some pathogens rare or difficult to diagnose;
2 ° to confirm the diagnosis in the peripheral laboratories;
3 ° participate in crop data in systems of alert and surveillance on the collection, recording, processing and analysis of data in health care.
The Committee of insurance is also empowered to conclude a framework agreement, which determines the General rules of contract applicable to the whole of the collaboration agreements concluded for these purposes with the Scientific Institute of public health - WIV - ISP.
Section 10. -Relief by the CPAs art. 17. article 16, § 1, of the Act, amended by the acts of 30 December 1995, December 30, 2001, August 22, 2002, 24 December 2002, December 10, 2004, December 27, 2006, 17 June 2009 and 19 May 2010 and by Royal Decrees of 25 April 1997 and September 17, 2005, is complemented by a 16 ° as follows: "16 ° fixed the amount of the lump sum financial support referred to in article 56 , § 8.".
S. 18. article 56 of the Act, as last amended by the Act of 26 December 2013, is complemented by a section 8, as follows: "§ § 8 8 ' The Institute grants annually from 2014 a financial intervention lump of a maximum of 150,000 euros the service public fédéral of programming Social Integration, fight against poverty, social economy and political cities for the benefits referred to in article 34 and which have been supported by the federal public Service while they enter into consideration for an intervention by the health care insurance.
The compensation shall be paid on production of an estimate that is transmitted by the federal public Service to the general Council no later than the first week of the month of December of the year concerned.
The general Council decides the amount, which is paid at the latest at the end of the year concerned.
Compensation is charged fully to the health care budget. "."
Section 11. -Imaging medical art.
19. article 69ter of the same Act §§ 1 to 10, 13 and 14, of the same Act, inserted by the law of 21 December 1994, is repealed.
S. 20. articles 69quater, 69quinquies, 69sexies and 69septies of the Act, inserted by the law of 21 December 1994, are repealed.
Section 12. -Conditions for intervention of the insurance health care for certain benefits article
21. in article 64, § 1, paragraph 1, of the Act, as amended, as last amended by the Act of December 10, 2009, 1 is replaced by the following: "1 ° have been installed and operated in accordance with the implementing provisions concerning the programming and the approval of the hospitals Act and its enforcement orders. From a date determined by the King only services provided by means of devices a list is established by the King, and which are fitted within the timeframe set by the King of a number of identification and a counter can be subject to a refund. Under conditions to be determined by the King, the care given certificate or document which stands in the place mentions the identification number that the Institute has assigned to the service at the place in which the benefits are made, as well as the identification number of the device by means of which the service is provided or the serial number of the delivery, as noted by the counter;"
Section 13. -College of doctors-directors and Advisory Board of the functional rehabilitation articles 22. the heading of title III, chapter I, section VI, of the Act, is replaced by the following: "Section VI. -College of doctors-directors' art.
23. in article 23, § 2, paragraph 2, of the Act, amended by law of August 22, 2002 and December 23, 2009, the phrase "To this end, the College of doctors-directors shall seek the opinion of the Advisory Council of the functional rehabilitation" is repealed.
S. 24. in article 23, § 4, paragraph 2, of the Act, the words ", after the communicating to the Advisory Board of the functional rehabilitation," and the sentence "If no observation was made by this Council within a period of thirty days from the receipt of the notice, it is deemed to approve the latter" are repealed.
25. article 24 of the Act is repealed.
Section 14. -Functional rehabilitation services art.
26. in article 71 of the Act, paragraph 2 is replaced by the following: "the budgetary annual target for the provision of functional rehabilitation referred to in article 34, 7 °, 7 ter °, 7 ° c and 7 ° d, is set in the context of the procedure provided for in articles 38, 39 and 40, the College of doctors-directors referred to in article 23 that" ', for these functional rehabilitation services, the role of the commission of agreements provided for in article 38. '
Section 15. -Reference amounts s.
27. in article 56ter, § 1, of the same law, replaced by the law of December 19, 2008, "version 15.0" shall be replaced by the words "hard 28.0".
S. 28. in article 56ter, § 4, first sentence, of the Act, replaced by the law of December 19, 2008, the words "and paragraph 11" shall be inserted between the words "paragraph 3" and the word "concerning".
29. in article 56ter, § 5, 1 °, b., of the same Act, replaced by the law of December 19, 2008, the first indent is replaced by the following: "- for the APR - DRG, degree of clinical severity 1 or 2 and group benefits for which the result calculated in point a, first indent, is positive;"
"calculation by hospital amount differences between actual expenditures covered admissions to the § 1, taking into account the limitations referred to in § 2, and, on the other hand, the median national expenditure corresponding by APR - DRG, by degree of clinical severity 1 or 2 and by group of benefits."
S. 30. article 56ter § 9, of the Act be replaced by the law of December 19, 2008, is replaced by the following: "§ 9 diagnosis groups are formed on the basis of the"All patient Refined Diagnosis related groups, Definitions Manual, Version 28.0": 1st APR - DRG 024 - extracranial vascular Procedures, APR - DRG 073 - Procedures on the eye except in the orbit, APR - DRG 097 - Procedures on tonsils and adenoids adenoidales" , APR - DRG 171-Implantation of pacemaker standing without myocardial infarction, Cardiac decompensation, or shock, APR - DRG 176 - replacement of pacemaker and cardiac defibrillator, APR - DRG 180 - other procedures on the circulatory system, APR - DRG 225 - appendectomy, APR - DRG 228 - Procedures for hernia inguinal, femoral and umbilical, APR - DRG 263 - cholecystectomy laparoscopic, APR - DRG 301 - hip joint replacement, APR - DRG 302 - knee joint replacement , APR - DRG 313 - Procedures at the level of the knee and the lower part of the leg except the foot if the nomenclature 300344 - total or partial Meniscectomy code has been documented, APR - DRG 445 - other procedures of the bladder, APR - DRG 482 - Prostatectomy transuretrale, APR - DRG 513a - Procedures on uterus/annexes for malignancy not except Leiomyoma, so the code of nomenclature 43128 - total hysterectomy , abdominal has been documented, APR - DRG 513b - Procedures on uterus/schedules for non-malignant disease except Leiomyoma, if the code of nomenclature 431325 - total vaginal hysterectomy, including previous colporraphie and/or any subsequent colpoperineorraphie has been documented, APR - DRG 517 - Dilatation and curettage for non-obstetriques diagnostics, APR - DRG 518 - other procedures on the reproductive system of female and related If the code nomenclature 432703 - laparoscopy for intervention on the fallopian tubes, including the pneumoperitoneum testified, APR - DRG 519 a - Procedures on uterus/annexes for Leiomyoma, if the nomenclature 431281 - total hysterectomy, abdominal code has been documented, APR - DRG 519 b - Procedures on uterus/annexes for Leiomyoma, if the nomenclature 431325 - vaginal hysterectomy, abdominal code has been certified APR - DRG 540 - Cesarean, APR - DRG 560 - vaginal delivery;
2 ° APR - DRG 045-stroke and pre-cerebrale with infarction occluding, APR - DRG 046-Accident non-specific stroke and pre-cerebrale without infarct occlusion, APR - DRG 047 - transient ischemic attack (TIA), APR - DRG 134 - pulmonary embolism, APR - DRG 136 - malignant respiratory disease, APR - DRG 139 - another pneumonia, APR - DRG 190 - acute myocardial infarction, APR - DRG 198 - Angina and coronary atherosclerosis, APR - DRG 204 - Syncope and collapse APR - DRG 244 - diverticulitis and diverticulosis, APR - DRG 465 - urinary lithiasis and acquired obstruction of upper urinary tract."
S. 31. in article 56ter, § 11, of the same Act, replaced by the law of December 19, 2008 and amended by the Act of March 19, 2013, 1 is replaced by the following: "1 ° in the benefits group defined in § 8, 3 °, the benefits of article 22 (physiotherapy) are excluded from the calculation of the reference amounts for the five following diagnostic groups ": APR - DRG 045 - stroke and occlusion pre-cerebrale with infarction, APR - DRG 046 - non-specific stroke and pre-cerebrale without infarct occlusion, APR - DRG 139 - another pneumonia, APR - DRG 301 - hip joint replacement, APR - DRG 302 - knee joint replacement."
S. 32. in article 56ter, paragraph 12, of the Act, replaced by the Act of March 19, 2013, 1 is replaced by the following: "1 ° diagnosis APR - DRG 190 group is divided into groups of APR - DRG 190 - acute myocardial infarction diagnosis if the admission takes place in a hospital that is not in the year of implementation of a programme of care B or B1 alone or in association and APR - DRG 190 - acute myocardial infarction if the admission takes place in a hospital that has, during the year of application concerned, of a programme of care B or B1 alone or in combination; "."
S. 33. in article 56ter, paragraph 12, of the Act, replaced by the law of March 19, 2013, 2 ° is replaced by the following: "2 ° groups diagnostic APR - DRG 45, APR - DRG 46, APR - DRG 139, APR - DRG 301 and APR - DRG 302 are divided into groups of diagnostic APR - DRG 45 - stroke and pre-cerebrale occlusion with infarction, if the admission takes place in a hospital that" , during the year of application, has agreement with the Committee of insurance for a revalidation of disorders (neuro) locomotives (7.71 or 9.50), APR - DRG 46 - non-specific stroke and occlusion pre-cerebrale without infarction if the admission takes place in a hospital which, during the year of application, made with the Insurance Committee an agreement of revalidation of disorders (neuro) locomotives (7.71 or 9.50) APR - DRG 139 - another pneumonia, if the admission takes place in a hospital which, during the year of application, made with the Insurance Committee an agreement of revalidation of disorders (neuro) locomotives (7.71 or 9.50), APR - DRG 301 - hip joint replacement, if the admission takes place in a hospital which, during the year of application, made with the Insurance Committee an agreement of revalidation of disorders (neuro) locomotives
(7.71 or 9.50), APR - DRG 302 - knee joint replacement, if the admission takes place in a hospital which, during the year of application, made with the Insurance Committee an agreement of revalidation of disorders (neuro) locomotives (7.71 or 9.50), APR - DRG 45 - stroke and occlusion pre-cerebrale with infarction, if the admission takes place in a hospital which, during the year of application, concluded with the Insurance Committee no convention revalidation of disorders (neuro) locomotives (7.71 or 9.50) APR - DRG 46 - non-specific stroke and occlusion pre-cerebrale without infarction if the admission takes place in a hospital which, during the year of application, concluded with the Insurance Committee no convention revalidation of disorders (neuro) locomotives (7.71 or 9.50), APR - DRG 139 - another pneumonia, if the admission takes place in a hospital which, during the year of application, concluded with the Insurance Committee no convention revalidation of disorders (neuro) locomotives (7.71 or 9.50) APR - DRG 301 - hip joint replacement, if the admission takes place in a hospital which, during the year of application, concluded with the Insurance Committee no convention revalidation of disorders (neuro) locomotives (7.71 or 9.50), APR - DRG 302 - knee joint replacement, if the admission takes place in a hospital which, during the year of application, concluded with the Insurance Committee no convention revalidation of disorders (neuro) locomotives (7.71 or 9.50). "."
S. 34. in section 156bis of the Act of 29 April 1996 on the social provisions, inserted by the law of 24 December 2002 and amended by the Act of July 24, 2008 1 paragraph is replaced by the following: "the technical cell has, according to the terms to be determined by the King by Decree deliberated in the Council of Ministers and after receiving the opinion of the Committee on the protection of privacy and data the jurisdiction of pair data other than the data defined in article 156, in relation to the tasks defined in articles 263 and 264 of the programme act of 24 December 2002 and for the institutions defined in article 278, paragraph 5, of the Act. The King determines the same procedure the date of entry into force of this jurisdiction of the technical cell, which for coupling to the benefit of the Intermutualiste Agency is limited to the couplings with the representative sample referred to in article 278, paragraph 5, of the Act. The competence of the technical cell coupling data other than those of the supra representative sample with the data referred to in article 156 in favour of the Agency Intermutualiste is determined by the King following the same procedure, after consultation with the multi-stakeholder Structure hospital policy."
S. 35. articles 27 to 33 apply to admissions that end after December 31, 2013.
Section 16. -Drug biological arts. 36A article 73, § 2, of the law on compulsory insurance health care and benefits, co-ordinated on 14 July 1994, replaced by the law of 24 December 2002 and amended by the royal decree of September 17, 2005 and by the laws of the 27 December 2005, December 13, 2006, June 8, 2008, December 19, 2008, December 22, 2008, December 23, 2009 , December 29, 2010 and June 22, 2012, the following changes are made: 1 paragraph 3 °, 4 °, and paragraph 9, 3 °, are each time complemented by the words the following point "(et dont la base de remboursement n'est pas supérieure à la base de remboursement calculée sur base dele de prix théorique ex-usine dele de médicament biologique de référence visé àle a), at the time of the reimbursement of the first reimbursable medicinal product authorized in accordance with article 6bis" , § 1, paragraph 8, of the law of 25 March 1964 on medicines that contains essentially the same biological substance, reduced by 15% and increased according to the rules laid down in article 35B, § 1, paragraph 4 ";
2 ° paragraph 3 is supplemented by 5 ° as follows: "(5° deles de spécialités pharmaceutiques remboursables qui: a) are the reference biologic drug reimbursable pharmaceutical specialities authorized under article 6bis, § 1, paragraph 8, of the law of 25 March 1964 on medicines or biological drugs that contain essentially the same biological substances as reference biological drugs but were not allowed in accordance with article 6bis" , § 1, paragraph 8, of the law of 25 March 1964 on medicines;
(b) and the basis of repayment is not more than the basis of refund calculated on the basis of the price theoretical ex-factory of the reference biological medicinal product concerned referred to under a), at the time of the reimbursement of the first refundable medicinal product authorized in accordance with article 6bis, § 1, paragraph 8, of the law of 25 March 1964 on medicines that contains essentially the same biological substance reduced by 15% and increased according to the rules laid down in article 35B, § 1, paragraph "4;
3 ° paragraph 9 is supplemented by 4 ° as follows: "(4° deles de spécialités pharmaceutiques remboursables qui: a) are the reference biologic drug reimbursable pharmaceutical specialities authorized under article 6bis, § 1, paragraph 8, of the law of 25 March 1964 on medicines or biological drugs that contain essentially the same biological substances as reference biological drugs but were not allowed in accordance with article 6bis" ((, § 1, paragraph 8, of the law of 25 March 1964 on medicines b) and the basis of repayment is not more than the basis of refund calculated on the basis of the price theoretical ex-factory of the reference biological medicinal product concerned referred to under a), at the time of the reimbursement of the first refundable medicinal product authorized in accordance with article 6bis, § 1 ", paragraph 8, of the law of 25 March 1964 on medicines that contains essentially the same biological substance, reduced by 15% and increased according to the rules laid down in article 35B, § 1, paragraph 4"
Section 17. -Drug art. 37. in article 72bis, § 1, of the Act, inserted by the Act of 20 December 1995 and as last amended by the Act of 22 June 2012, the following changes are made: 1 ° 5 ° is replaced by the following: "5 ° according to conditions to be set by the King, provide a unique barcode accepted packaging, from the date of entry into force of the refund , as well as packaging "in bulk" and hospital packs containing specialities of pharmaceutical forms "oral-solid" intended to be used in the preparation of individual medication referred to in article 12bis, paragraph 3, of the law of 25 March 1964 on medicines and provide a distinctive thumbnail allowed packs, from the date of entry into force of the refund , and not to sign such a sticker on a packaging not allowed; ";
2 ° 7 ° is replaced by the following: "7 ° communicate to the Federal Agency for drugs and health products, hereinafter referred to as the FAMHP, spontaneously and in accordance with article 6, § 1ersexies, of the drug law of 25 March 1964, any breach of the 2nd;".
S. 38. in article 72bis, § 1bis, of the same Act, inserted by the law of December 22, 2008, the following changes are made: 1 ° in the 1st paragraph, the sentences "the applicant who is not able to comply with the obligation referred to in paragraph 1, paragraph 1, 1 °, shall inform the service of health care of the Institute, in accordance with paragraph 1, 7 °" not later than the eve of the entry into force of the refund, stating the presumed date that specialty will be available and the reason for unavailability.
This unavailability is mentioned by the service on the web site of the Institute."are replaced by the following sentence:"If the applicant is not able to comply with the obligation referred to in paragraph 1, paragraph 1, 1 °, such unavailability is mentioned by the Department of health care of the Institute on the web site of the Institute.";
2 ° in paragraph 2, the words "the Institute health care service" are replaced by the words "the FAMHP";
3 ° in the Dutch text of paragraph 2, the word "paragraef" shall be replaced by the word "paragraaf";
4 ° paragraph 3 is replaced by the following: "If Institute health care service is informed of the unavailability of a medicinal product otherwise than by the applicant or if the FAMHP, the service shall immediately inform the FAMHP and it asks for confirmation to the applicant that the medicinal product is actually unavailable. The applicant has a period of 14 days from the receipt of this request to confirm or refute the unavailability. If the claimant reversed the unavailability, it shall inform the Department of health care of the Institute by sending recommended with acknowledgement of receipt and it attached to sending evidence attesting that the medicinal product is available. If the applicant confirms the unavailability, it shall inform the FAMHP in accordance with the § 1, 7 °, and specify the start date, the presumed end date and the reason for unavailability. This unavailability is mentioned by the service on the web site of the Institute.
The mention of unavailability on the web site of the Institute has no bearing on the reimbursement of the specialty concerned, which thus remains on the list. However, if the downtime is
maintains, the specialty concerned is removed from the right of the list the first day of the twelfth month following the date of the beginning of the absence. On the other hand, if the applicant does not respond within the time limit, or if the elements it provides are insufficient to establish with certainty the availability of the medicinal product, the specialty is removed as quickly as possible the list of full rights and without taking into account the procedures laid down in article 35bis. ";
5 ° in paragraph 4, the words "the earlier the Institute" shall be replaced by the words "as soon as possible the FAMHP".
39. in article 77quinquies of the Act, inserted by the law of December 27, 2012, the following changes are made: 1 ° in the § 1, paragraph 2, the words "the technical Council of the radioisotopes" are replaced by the words "to the FAMHP";
2 ° in the § 2, paragraph 1 is replaced by the following: "If the Institute health care Service is informed of the unavailability of a radiopharmaceutical otherwise than by the firm or where appropriate by the FAMHP, the Service shall immediately inform the FAMHP and it asks for confirmation to the firm that the product is actually unavailable." The firm has 14 days from the receipt of this request to confirm or refute the unavailability by sending recommended with acknowledgement of receipt. If it reverses it, she attached to sending evidence attesting that the product is available. If the firm confirms the unavailability, it specifies the start date, the presumed end date and the reason for the unavailability at the FAMHP. ";
3 ° in § 3, the words "to the FAMHP" are inserted between the words "If the firm communicates" and the word "only".
40. in article 77quater, of the same Act, inserted by the law of May 19, 2010, the words "as well as for each unit actually issued refundable specialties with a pharmaceutical form" oral - solid "issued to the pharmacy open to the public to a beneficiary staying in a House rest and care or nursing home for elderly people, does not have a pharmacy or a deposit of medicinal products in accordance with the provisions of the Service public federal public health" ", Food chain safety and environment," shall be inserted between "refundable" words, and the words "the unique barcode".
S. 41. article 69 of the law of 27 April 2005 relating to the control of the health care budget and amending various provisions regarding health, amended by the law of December 19, 2008, December 23, 2009, December 29, 2010, 17 February 2012 and December 27, 2012, is supplemented by a paragraph worded as follows: "an exception to the application of paragraphs 10 11 and 13 shall also be granted to medicinal products with the basis for reimbursement of a specialty consisting of a fixed amount per indication, or treatment or consideration for the drug or drugs that are provided for this indication, this treatment all this review."
Section 18. -Duties of caregivers s. 42. in the law on compulsory health care and benefits insurance, co-ordinated on 14 July 1994, it is an article inserted 73quater as follows: "article 73quater. § 1. Is required to register at the Crossroads Bank for enterprises to obtain a business number: 1 ° any legal person incorporated under Belgian law and any legal person of foreign and international law n which has a headquarters in Belgium, which brings together caregivers within the meaning of article 2,), who carry their economic and professional activities principal or supplementary title under this Act;
2 ° any association without legal personality which brings together caregivers within the meaning of article 2, n), who carry their economic and professional activities principal or supplementary title under this Act;
3 ° any person physical, dispenser of care within the meaning of article 2, n), which, as autonomous entity exercises an economic and professional activity, main or complementary in the context of this Act.
The Minister who has social affairs in charge determines the terms and conditions that is made to the Institute, the business number, of the identity of the person responsible for communication, of the identity of providers component covered entities and those of the permanent update of the data.
2. The caregivers within the meaning of article 2, n), or groups exercising their economic and professional activities principal or supplementary title under this Act, shall give to health care Service any changes concerning the elements of their record of registration or approval at the Institute.
The Minister who has social affairs in his or her attributions determines the elements of the file subject to this requirement and the administrative arrangements for communication of these elements, the closing of a folder and the reopening of a closed folder."
S. 43. article 76 of the Act is repealed.
S. 44. article 42 comes into force January 1, 2015.
S. 45. article 43 comes into force January 1, 2015.
Section 19. -Benefits in the context of clinical scientific research article 46. in article 34 of the Act, section 2, inserted by the law of 22 February 1998, is replaced by the following subparagraphs: 'health care insurance is not involved in the services performed for aesthetic purposes, except under the conditions laid down by the King, after opinion of the Insurance Committee.
For services performed in the context of scientific research or clinical trials, health care insurance occurs only in the cost of benefits applied in treatment if they meet generally accepted clinical recommendations or the scientific consensus. They are documented and justified in the medical records of the insured by the investigator referred to in article 2, 17 °, of the experiments on the human act of May 7, 2004.
Health care insurance is not involved in benefits whose execution is a specific requirement of the Protocol referred to in article 2, 22 °, of the above-mentioned Act and which exceed made benefits referred to in paragraph 3. The investigator maintains a list of scientific research and clinical trials in which patients are included.
The King may lay down rules for the application of this paragraph."
Section 20. -Funding of daycare for arts practitioners 47. article 56 of the Act, as last amended by the Act of 26 December 2013, is complemented by a § 10, as follows: "§ § 10 10" The general Council fixed the maximum budget for the FPS Interior in order to finance the cost of attendants to the system of unified appeal under article 9A, § 1, of royal decree No 78 on the exercise of the professions of health care.
These expenses are fully charged to the budget for health care and are defined annually within the overall budgetary goal."
Section 21. -Dependents s. 48. article 126 of the Act be replaced by the law of December 19, 2008, is replaced by the following: "the King lays down the conditions for the inclusion of the dependant, on a proposal from the Working Group insurability as referred to in article 31bis
It determines also on proposal of the health working group, from which licensee is by registered priority a person who, pursuant to article 32, paragraph 1, 17 °, 18 °, 19 °, can be registered as dependants from different owners.
The fixed King on the proposal of the Working Group insurability, conditions under which it may be waived where the circumstances of the case so warrant.
If it is a child, the registration is done in accordance with the choice of parents for whom filiation is established, unless it is for a child referred to in article 123, 3, f) of the royal decree of 3 July 1996 implementing Act on compulsory insurance health care and benefits, co-ordinated on 14 July 1994.
A first registration of a dependent child referred to in article 123, 3, a) of the royal decree supra can be done ex officio without having the licensee designated in application of the priority rules apply.
S. 49. the King sets the date of entry into force of this section.
Section 22. -Transaction s. 50A article 16, § 1, of the same law is inserted a new point 16 ° as follows: c of the annex as attached to the royal decree of 14 September 1984 establishing the nomenclature of health benefits in " matter of compulsory insurance health care and allowances or chapter VI of the list attached to the royal decree of 21 December 2001 laying down the procedures, time limits and conditions for intervention of the compulsory insurance health care and benefits in costs for proprietary medicinal products and which relate to services performed with a PET brought non-approved scans into account by hospitals.
In the context of each of these transactions, it can give up to 35% of the amount of the benefits referred to in paragraph 1. Each transaction is subject to the prior written commitment
the competent person from the hospital to a refund within 3 months of at least 65% of the contentious benefits referred to in paragraph 1."
S. 51. article 50 comes into force the first day of the month following the publication of this Act in the Moniteur belge and will cease to apply on the first day of the fourth month following publication.
CHAPTER 2. -eHealth Section 1st. -Committee of users article 52. in article 5 (8) of the Act of August 21, 2008 relating to the institution and the Organization of the eHealth platform and on various provisions, the words ", of the non-profit association referred to in article 37," are repealed.
S. (53. article 15, § 1, paragraph 1, 3 °, of the same Act, is supplemented by an e) as follows: "e) the president of the Comité de concertation of the users referred to in article 22."
S. 54. article 22 of the Act is replaced by the following: 'article 22. it is created with the eHealth platform a consultation of the users Committee. The Conciliation Committee assists the Management Committee of the eHealth platform in the performance of its tasks.
The Conciliation Committee is responsible for promoting the exchange of electronic information in the interest of the patient, and secure data sharing between health actors authorized by the sectoral Committee of social security and health, and this in order:-to enhance the quality and continuity of health care by ensuring continuous availability of patient health data;
-to optimize collaboration and communication between health care providers to improve the monitoring of the patient.
Therefor, the Conciliation Committee is responsible for formulating the Management Committee of the eHealth platform of the proposals of the notice, on its own initiative or on request, in particular: 1 ° of organisation of future flows of electronic data for the collection, processing and provision of clinical data and organization of records relating to different clinical areas where this Organization concerning care providers;
2 ° of designation of the intermediate organization as defined under law of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data, responsible for the operational organization of flows and records referred to in 1 °, provided that the platform eHealth can not achieve this mission provided for in article 5 , 8° ;
3 ° definition of therapeutic relationships, procedure for the informed consent of patients and the right of scrutiny of the patients on the use of data concerning them unless the rules have already been set by the Management Committee or the sectoral Committee of social security and of health either before the entry into force of this Act , after opinion of the Conciliation Committee.
Consultation of the Comité de concertation is required in matters referred to in paragraph 3. In these cases, the Conciliation Committee form a notice within three months by a majority of two-thirds of the members of the Conciliation Committee. If this majority is not reached, considerations of the majority and the minority are, if any, specified in the notice.
The eHealth platform and the Conciliation Committee shall periodically arrange a round table involving the different actors of the health sector to assess the progress of the implementation of eHealth and list the needs.
The Conciliation Committee can create its members of working groups charged with specific missions.
It shall establish its rules of procedure and submit it for the approval of Ministers."
S. 55. article 23 of the Act is replaced by the following: 'article 23. the Coordination Committee is chaired by a doctor and includes 32 members, including: 1. the following members voting members: a. Eleven members, including seven doctors, representing care providers and care facilities, as referred to in article 3, 2 ° and 3 °, as well as representative organizations of care providers;
(b) seven members nominated by organizations insurers;
c. four members nominated by the representative organisations of patients who sit on the Federal 'patient rights' Commission.
2. the following members who have consultative voice: a. six members who represent entities Federated;
b. four members representing the federal authority, including:-a member who represents the platform eHealth;
-a member who represents the INAMI;
-a member representing the federal public Service health, food chain safety and environment.
The King appoints the Chairman and the members of the Conciliation Committee. He said, if appropriate, skills, and fixed its modalities of operation.
The King determines also the amount and the conditions for granting of attendance fees to be allocated to the president.
Except in the cases referred to in article 22, the King may determine the cases in which consultation of the Conciliation Committee is mandatory. In these cases, the Comité de concertation form an opinion within three months.
The eHealth platform supports the operating costs of the Conciliation Committee and working groups created in her womb and ensures the secretariat."
S. 56 Chapter 11 of the Act, including sections 37 to 40, is repealed.
S. 57. in article 17 bis, § 1, paragraph 1, 3 ° bis, of the law of 15 January 1990 on the institution and the Organization of a Crossroads Bank for social security, inserted by the law of August 21, 2008, the words "and the association referred to in article 37 of the law of August 21, 2008 relating to the institution and the Organization of the eHealth platform" are repealed.
Section 2. -Provisions various arts. 58. in article 32, paragraph 2, of the Act of August 21, 2008 to the institution and the Organization of the eHealth platform and amending various provisions, the words "entry into force" are replaced by the words "publication in the Moniteur belge".
S. 59. in article 21 of royal decree No 78 of 10 November 1967 on the exercise of the professions of health care, last amended by the Act of 9 July 2004, the following changes are made: has) 1st paragraph is replaced by the following subparagraphs: "any order: 1 ° specify as far as possible the instructions for use of the drug;"
2 ° is dated by the physician, by the dental practitioner or any other person who can prescribe drugs by or under this royal order, on paper or electronically using a procedure established by the Committee of the eHealth platform management and approved by the sectoral Committee of social security and health;
3 ° is signed by the physician, by the dental practitioner or any other person who can prescribe drugs by or under this royal order, or the identity of the doctor, practitioner of dentistry or any other person who can prescribe drugs by or under this royal order is authenticated using a procedure established by the Committee of the eHealth platform management and approved by the sectoral Committee social security and health.
The King may extend the application of the procedures mentioned in paragraph 1, 2 ° and 3 ° of the first paragraph to categories other than the requirements of drug orders. ";
(b) in paragraph 2, becoming paragraph 3, the phrase "The King may determine the conditions of application, so that possible derogations to these requirements for the use of the electronic signature in hospitals and determines the date of entry into force of this provision." is repealed.
60. the royal decree of July 19, 2013, containing various provisions on probative value is confirmed with effect from 1 January 2012.
CHAPTER 3. -Modification of the programme law of July 20, 2006 single Section. -Second pillar of pensions s. 61. in article 55 of the programme law of July 20, 2006, as amended by the laws of 27 December 2006, December 22, 2008, December 29, 2010, and March 19, 2013, paragraphs 6, 7 and 8 are replaced by the following: "from 2012, an amount of 904.653 euros is transferred from the Institut national d'assurance maladie-invalidité to the national agency of pensions for workers bound by a contract of employment with an employer of" public sector. An amount of 8.083.660 euros is transferred from the savings fund sector in the Federal sectors in favour of workers bound by a contract of employment with an employer in the private sector. These transfers take place each year in June. From 2013, these amounts are adapted annually to the evolution of the average arithmetic of the health index from the month of June and the figures of the index of the previous three months between June 30 of last year and June 30 of the year preceding. The report expressed by these developments is rounded to four decimal places, upwards if the fifth digit is at least a 5 and down to other cases.
The amounts are charged by the Institute to the budget of the health care insurance. Amounts paid in 2013 and which concerned the year 2012 are charged by the Institute to the insurance health care 2012 budget.
From 2013, an amount of 1.427.000 euros was transferred from the national Institute for sickness and invalidity insurance to the national Office for pensions for workers
employees bound by a contract of employment with an employer in the public sector. This transfer takes place every year in June. From 2014, this rate shall be adjusted each year to the evolution of the average arithmetic of the health index in the month of June and indices of the previous three months between June 30 of last year and June 30 of the year preceding. The report expressed by these developments is rounded to four decimal places, upwards if the fifth digit is at least a 5 and down to other cases. This amount is charged by the Institute to the budget of the health care insurance. The amount paid in 2014 and which concerned the year 2013 is charged by the Institute to the insurance health care 2013 budget. "."
CHAPTER 4. -Modification of the programme law (I) of 27 December 2006 article 62. in article 245, § 1, paragraph 1, of the programme law (I) of 27 December 2006, replaced by the Act of March 19, 2013, '12, 6 °' shall be replaced by the words "16, § 1, 3 ° '.
CHAPTER 5. -Amendment of the law of 25 January 1999 on the social provisions article 63. articles 130 and 131 of the Act of 25 January 1999 on the social provisions are repealed.
CHAPTER 6. -Experimentation on human art. 64. in article 31, § 2, paragraph 2, of the experiments on the human act of 7 May 2004, the second sentence is repealed.
S. 65. in article 191, paragraph 1, of the law on compulsory health care and benefits insurance, co-ordinated on 14 July 1994, amended by the law of December 15, 2013, 22 ° is repealed.
CHAPTER 7. -Blood and blood of human origin s. derivatives 66. in chapter II of Act of 5 July 1994 on blood and human blood derivatives, it is inserted an article 4/1, as follows: "article
4/1. The establishments referred to in article 4 are responsible for the following public service: 1 ° organizing the collection of whole blood donors volunteers and volunteers to ensure the supply of labile blood derivatives;
2 ° ensuring the steady supply of blood total and labile blood derivatives;
"3 ° provide the amount of plasma residual, if necessary supplemented by plasma of Apheresis, required for self-sufficiency, to the Chargé de mission referred to in article 20/1, on the basis of a price fixed by the King."
S. 67. in the same law, a chapter III/1 is inserted: 'chapter III/1.
Provisions on self-sufficiency of plasma derivatives".
S. 68. in chapter III/1, inserted by article 67 article be inserted a 20/1 as follows: "article 20/1.
A charge of mission, designated under the law of 15 June 2006 on public procurement and some markets works, supplies and services, is responsible for a period of five years of treatment of plasma issued by institutions that are approved by the Minister that public health in its attributions under section 4 of this Act the quarantine of plasma and its maintenance, pending its acceptance, its distribution or its rejection, to ensure an adequate supply of stable plasma derivatives to hospitals, the establishment and maintenance of a strategic reserve commodity concerned.
Are considered to be stable plasma derivatives normal human immunoglobulin for intravenous administration (ATC: J06BA02), albumin solutions:-albumin 20% solution for intravenous infusion;
-Stable solution of 4% plasma proteins (ATC BO5AA01).
The King may modify the definitions of human immunoglobulins and albumin solutions, as referred to in paragraph 2.
This officer has a certificate of compliance with the Community legislation for the standing of the plasma, referred to the 1.1 folder, c), of part III of Schedule 1 to the royal decree of 14 December 2006 on medicinal products for human and veterinary use, and permission marketing, referred to in article 6, § 1, paragraph 1, of the law of 25 March 1964 on medicines on the basis of which the licensed activities are performed. The head of mission has a traceability system that ensures that the processing is performed exclusively on the basis of plasma issued by approved establishments.
Hospitals provide at least 50% of immunoglobulins and 100% albumin solutions they need with the Chargé de mission in accordance with the prices, terms and conditions laid down by the King the King is empowered to take all measures to ensure the implementation of this provision. It determines inter alia for this purpose: 1 ° the duration of the period of malfunctioning of the market during which self-sufficiency must be ensured;
2 ° the hierarchy of indications for which stable plasma derivatives are so prescribed;
3 ° the volume of plasma required for self-sufficiency;
4 ° the manner in which the market disruption event is witnessed by the Federal Agency for drugs and health products.
Pending the appointment of the head of mission, contractual commitments made by institutions approved before the entry into force of this chapter with the Central Department of fractionation of Red scrl are maintained until December 31, 2015 at the latest. The concerned firm is responsible for this date of the tasks referred to in paragraph 1. Stable plasma derivatives plasma issued by approved establishments are delivered to hospitals according to the basis of reimbursement laid down in application of article 35A of the Act on compulsory insurance health care and benefits, co-ordinated on 14 July 1994. Until 31 December 2015 at the latest shall be considered to be self-sufficiency reserve half of the overall use of immunoglobulins and 100% of the overall use of albumin on the year 2012 solutions as found by the national Institute for sickness and invalidity insurance.
Hospitals will provide stable plasma derivatives products in the context of self-sufficiency, in accordance with the rates and conditions set by the King.
For the years 2014-2015, SCRL Department split from the Red Cross Central is liable to pay a contribution to the national Institute for sickness and invalidity per litre of plasma derivatives were provided to Belgian hospitals against the basis of reimbursement established pursuant to the Insurance Act mandatory health care. This contribution amounts to 49.40 euros per litre of plasma. The total amount of the contribution is limited in 2014-2015 the amount calculated on the basis of the amount of plasma provided in 2012. An advance of 75% calculated on the basis of the amount of plasma provided in 2012 shall be paid to the NIHDI respectively before 31 December 2014 and 31 December 2015. The balance is paid respectively until June 30, 2015 and June 30, 2016. Where it is found that the amount of plasma provided is lower than that of 2012, the contribution is diminished in proportion."
S. 69. article 191, paragraph 1, insurance compulsory health care and allowances, coordinated Act on July 14, 1994, as last amended by the law of December 15, 2013 is supplemented by a 33 ° as follows: "33 ° the product of the levy referred to in article 20/1, paragraph 9, of the Act of 5 July 1994 concerning blood and human blood derivatives".
S. (70. in article 192, paragraph 4, 1 °, j), paragraph 1, of the Act, replaced by law program of 22 December 2003 and amended by laws of December 19, 2008, 17 June 2009 and 27 December 2012, the words "32 °" are replaced by the words "33 °".
CHAPTER 8. -Support of undue amounts not recovered by insurers Section 1st. -Costs of administration art.
71. in article 194 of the Act, as amended by the royal decree of March 17, 1997, it is inserted a paragraph 3 as follows: "§ § 3 3" Is also considered as administrative costs, the part of expenditure paid unduly which cannot be recovered in accordance with article 17, paragraph 2, of the law of 11 April 1995 establishing the Charter of the social insured, determined in accordance with the provisions of this paragraph.
These amounts are calculated annually, by sector, depending on the percentage of the indus referred to in paragraph 1 compared to the total amount of the expenses incurred by the insurer considered in this sector organization.
These amounts are fixed increments as follows: has) in the area of benefits:-0% of unrecoverable indus that represent a percentage of the total amount of spending less than 0.05%.
-10% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.05 and less than 0.1%;
-25% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.1% and less than 0.2%;
-50% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.2% and less than 0.35%;
-75% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.35% and less than 0.5%;
-100% unrecoverable Indus that represent a percentage of the total amount of expenditures greater than or equal to 0.5%.
(b) in the health care sector:-0% of unrecoverable indus that represent a percentage of the total amount of expenditures under 0.0069%;
-10% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0069, 0.0083% below;
-20% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0083% but less than 0,0097%;
-30% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0,0097% and 0,0111% below;
-40% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0,0111% and less than 0.0125%;
-50% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal than 0.0125% and less than 0.0139%;
-60% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0139% and below 0.0153%;
-70% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0153% and below 0.0167%;
-80% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0167% but less than 0,0181%;
-90% of unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0,0181% and 0.0195* % below;
-100% unrecoverable Indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0195* %.
Expenditure paid unduly, which can not be recovered in accordance with article 17, paragraph 2 of the law of 11 April 1995 establishing the Charter of the insured shall be communicated to the Institute in the manner laid down in article 164 c for the compensation sector in records of expenses relating to the health care insurance for the health care sector.
If the insurer body determines that the error within the meaning of article 17, paragraph 2 of the above-mentioned Act is attributable to another institution of social security, the sums concerned are deducted from the amounts taken into account for the calculation of the percentage provided for in paragraph 3, subparagraph 2."
S. 72. article 71 shall enter into force on January 1, 2014 and the calculation provided for in article 194, § 3, paragraph 2, of the law on compulsory insurance health care and benefits, co-ordinated on 14 July 1994 will be performed for the first time in the month of April 2015.
Section 2. -E-mail message for unduly paid benefits art. 73. article 164quater of the Act, inserted the programme law of March 29, 2012, was withdrawn at the date of 1 January 2014.
S. 74. in the same Act, it is inserted an article 164quater as follows: "insurers are required to communicate to the Institute, by mutuality or regional office, by licensee and nature of the risk, the amount of benefits paid unduly, the cause of the undue payment and if it results from an error, fault or negligence of the insurance fund.
The insurer Agency shall also, in the manner referred to in paragraph 1, the amounts of compensation recovered, unrecovered amounts and the reasons for which these amounts have not been recovered. It also communicates the unrecovered amounts that are enrolled in charge of its administration costs and unrecovered amounts that are considered as expenses of the scheme. These data should be communicated separately with respect to the non-recoverable amounts in accordance with article 17, paragraph 2 of the law of 11 April 1995 establishing the Charter of the insured.
The data referred to in paragraphs 1 and 2 shall be communicated by the means of an electronic process approved by the Institute no later than the last day of the month following each calendar quarter to which they relate. "."
S. 75. article 74 comes into force January 1, 2015.
Section 3. -Limitation period for the recovery of unduly paid benefits art.
76. article 174, paragraph 3, of the Act, inserted by the law of December 19, 2008, is repealed.
CHAPTER 9. -Measures to combat social fraud Section 1st. -Commission Anti fraud art. 77. in title II of the Act, it is inserted an article 13/1 as follows: "article 13/1. § 1. Within the Institute, it is installed a special commission called Commission Anti fraud, with an advisory and coordination role. This commission is chaired by the Deputy Head of the Institute or by an official designated by him.
This commission is composed jointly, on the one hand, of members of the health care Service, the evaluation and medical control Service and the Service of administrative control and, on the other hand, of representatives of the insurers. The services of the Institute members are appointed by the official leader of these Services, the members who represent insurers are designated within the Collège Intermutualiste National.
§ 2. In the field of the fight against fraud to the compulsory sickness and invalidity insurance, the commission is particularly responsible for: 1 ° the achievement of missions of studies for the simplification and coordination of the activities of the Institute and the Collège Intermutualiste National in the field of the implementation of the legal tasks of the Institute and the medical consultants;
2 ° the harmonization and coordination of sources of information between the Institute and the Collège Intermutualiste National for joint actions, or to avoid different actions in time, against the same target group or individual, in respect of the secrecy of the investigation are required to Institute control services;
3 ° the harmonization of the actions of the College Intermutualiste National and the services of the Institute in the detection and prosecution of fraud, in compliance with and without interference in the statutory powers of the Institute and the medical consultants services;
4 ° the proposal and development of methods of work within the legal framework existing to achieve uniformity of action;
5 ° the joint motion for adaptation of the regulatory recommendations, when necessary after analysis actions Intermutualiste National College and the services of the Institute.
6 ° the elaboration of guidelines to draw the outlines of the concept of "serious, precise and concordant evidence" referred to in article 77sexies.
The commission shall report semi-annually to the general Committee of management on the progress of the collaboration between the services of the Institute and the Collège Intermutualiste National in the field of the fight against fraud in the compulsory sickness and invalidity insurance.
§ 3. The King can establish additional rules in relation to the composition and operation of Anti fraud Commission. "."
S. 78. in title III, chapter V, of the same Act, it is inserted a section XXII, entitled "Provisions concerning the fight against fraud."
S. 79. in section XXII, inserted by article 74 article be inserted a 77sexies, as follows: "article 77sexies. If there are indices serious, precise and concordant of fraud on the part of a health care provider within the meaning of article 2, n, payments by insurers under the scheme of the third party paying may be suspended, totally or partially, for a maximum period of 12 months.
Each insurer or insured may communicate these indices in evaluation and medical control Service who can also act on its own initiative. If an insurer organization communicates clues to evaluation and medical control Service, it shall simultaneously communicate to other insurers.
The official leader of the assessment and medical control Service, or an official designated by him, shall notify the facts on which are based the clues to the health care provider by registered letter, which is supposed to be received the third business day after delivery to mail services. It invites the caregiver to transmit by registered letter its defences within a period of fifteen days.
After consideration of the means of defence, or in the absence of means of defence received within the time limit, the servant-leader or an official designated by him, shall take its decision. If he decided to suspend payments, it determines the duration of the period of suspension.
It also determines if the suspension is total or partial.
The binding decision of the servant-leader or an official designated by him, is motivated. It shall be notified by registered letter to the health care provider and takes effect, notwithstanding appeal, the third working day following that where the fold handed to postal services. Copy of the decision shall simultaneously be notified to insurers.
A non-suspensive appeal may be brought before the Tribunal of labour which is competent in accordance with article 167.
The suspension shall end ipso jure if, within a period of one year from the decision, no minutes of observation is established."
S. 80. in the same section XXII, it is inserted an article 77septies, worded as follows: 'Article 77septies. Benefits which it established that they are contrary to the rules referred to in article 73bis, 1 ° to 6 ° of the Act can more again be submitted for payment from the insurance fund.
S. 81. in article 153 of the Act be replaced by the law of December 19, 2008, a paragraph 2/1 is inserted, worded as follows: "§ 2/1. The findings factual and medical doctors Council made during the exercise of their monitoring tasks have probative force until evidence to the contrary.
With their probative value, these findings can be used by inspectors and controllers
referred to in articles 146 and 162 for the finding of infringements."
S. 82. in article 156, § 1 of the Act, restored by the law of 13 December 2006 and amended by the law of March 29, 2012, the third subparagraph is replaced as follows: "in cases where the debtor is in default, the insurers pursuant to article 206A, § 1, or the Administration of the the value added tax, registration and domains in application of article 206A ' ", § 2, can be responsible for recovery of amounts owed".
83. in article 164 of the Act, as last amended by the Act of December 10, 2009, paragraph 5 is replaced by the following: "the recovery of unduly paid benefits can be carried out in accordance with the provisions of article 206A, § 1, or in accordance with article 206A, § 2, with regard to the benefits which the recover can be accepted as justified as referred to in article 194" (, § 1, b). "."
84. in article 206A of the Act, inserted by the Act of 14 January 2002, the current text form, paragraph 2, the following changes are made: 1 ° a 1 paragraph worded as follows is added: "§ 1." Under the health care insurance, an amount that must be paid by insurers to a health care provider, can be used in full by these insurers for payment by set-off of amounts unduly received by the caregiver or the rules of any other claim which originated in this Act in its laws and regulations, in the conventions and agreements under this Act.
2 ° article is supplemented by a paragraph 3 as follows: "§ § 3 3" The amounts recovered are a recipe for the insurance health care as referred to in article 191 and are paid to the account of the Institute."
Section 2. -Medical control and sanctions art. (85. in the Dutch text of article 2, n), the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994, amended by the law of 24 December 1999 and 13 December 2006, the sign of punctuation "," is inserted between "tewerkstellen" and the word "die".
S. 86 article 73bis, 1 °, of the same Act, inserted by the law of 13 December 2006 and amended by the law of March 29, 2012, is supplemented by the words "or where they have been carried out or provided during a period of ban temporarily or permanently for the exercise of the profession".
S. 87. in article 141, § 1, paragraph 1, of the Act, as amended by the royal decree of 25 April 1997 and by the laws of the 24 December 1999, December 24, 2002, December 22, 2003, April 27, 2005, December 13, 2006, December 19, 2008, June 17, 2009 and March 29, 2012, 7 is repealed.
S. 88 A article 142, § 1, of the same law, restored by the law of 13 December 2006 and amended by the Act of 27 December 2006, the following changes are made: 1 ° in the paragraph 1, 2 °, the words "of the value of the same benefits" are replaced by the words "of repayment";
2 ° the § is supplemented by a paragraph, as follows: "where a health care provider is the subject of prosecutions resulting from a communication from the medical facts to the public prosecutor by the Service of evaluation and control, the Institute can be civil parties with a view to the recovery of benefits improperly reimbursed by the health care insurance. The amounts thus recovered are paid into the account of the Institute and recorded as revenue of the health care insurance."
89. in article 154 of the same Act, amended by the acts of 24 December 2002 and 19 December 2008, paragraphs 7 and 8 are repealed.
S. 90. in article 175, paragraph 2, of the Act, replaced by the law of December 22, 2008, "doctors-inspectors, the inspectors pharmacists, nurses-controllers and social controllers" are replaced by the words "doctors-inspectors, inspectors pharmacists and nurses-controllers".
S. (91a article 168quinquies of the Act, inserted by the law of May 19, 2010 and last modified by the law of March 29, 2012, the following changes are made: 1 ° in the § 2, 3 °, it a) is replaced by the following: ' a) resumed activity without the authorization referred to in article 100, § 2, or without complying with the conditions of the authorization; "
2 ° in the Dutch text of § 3, paragraph 5, the words "het werk" are replaced by the words "de werkzaamheid";
3 ° in the Dutch text of § 8, paragraphs 5 and 7, the word "word" is every time replaced by the word "is".
Chapter 10 financial transparency of health care art. 92. This chapter partially transposes Directive 2011/24/EU of the European Parliament and of the Council March 9, 2011, on the application of the rights of patients in cross-border healthcare.
S. (93. in article 2, n), of the Act on compulsory insurance health care and benefits, co-ordinated on 14 July 1994, amended by the acts of 24 December 1999 and 13 December 2006, the second sentence beginning with the words "includes" and ending with the words "health care"; is replaced by the following sentence: "are assimilated to care providers for the purposes of articles 53 , § 1, § 1bis and § 1B, 73bis and 142, the natural or legal persons which use them, which organize the dispensation of care or the perception of money owed by the care insurance health; "."
S. 94A article 50, § 3, paragraph 8, of the Act, the following amendments are made: 1 ° the word "incumbent" is replaced by "beneficiaries".
"2 ° in the French version of the text, the words" when he "shall be replaced by the words" when they "."
S. 95. in article 52 of the same Act amended by the laws of January 14, 2002 and December 13, 2005, is inserted a paragraph 2A, as follows: "the conventions and agreements contain clauses relating to the manner in which is carried out the control of compliance with the commitments by the caregivers who acceded. Without prejudice to the legal tasks of control of insurers, the competent committees shall transmit to the Insurance Committee a report on respect for the conventions and agreements, notably on basis of inquiries from beneficiaries."
S. 96. section 53 of the Act, the following amendments are made: has) 1st paragraph of § 1, amended by the law of January 25, 1999 and December 27, 2005, is complemented by the two sentences thus drafted: "that the health care provider performs benefits for its own account or for hire or reward, the amount paid by the beneficiary to the caregiver for performed services is mentioned on the party received the certificate of care given or" supplies the document or equivalent. As soon as a convention or an agreement has established rules on electronic invoicing by health care providers, the King fixed, on proposal of the Committee after consultation with the competent Committee of conventions or agreements and insurance, complementary data to be forwarded by the providers to insurers."
(b) there shall be inserted a paragraph 1/1, as follows: "§ 1 1. ' Payments may be levied for health benefits to perform or deliver within the limits laid down in the conventions and agreements."
Health care providers are required to give to the recipient a receipt in case of perception of deposit. ';
(c) there shall be inserted a paragraph 1/2, as follows: "§ 1/2."
Care providers are required to provide to the beneficiary a voucher made benefits giving rise to intervention by compulsory insurance and benefits is there not giving rise when these are performed with benefits that will give rise: 1 ° when making application of the system of the third party paying;
2 ° when the caregiver account to the recipient in addition to amounts for services giving rise to intervention by the compulsory insurance of the amounts for benefits that do not give rise to intervention by the compulsory insurance;
3 ° when the health care provider perceives of the recipient of the amounts after him have issued the certificate of care or supplies or the equivalent document referred to the § 1;
4 ° in the case where the certificate of care or supplies or equivalent document referred to the § 1, paragraph 1, is replaced by electronic data transmission by the health care provider to the insurer of the beneficiary body.
The total amount of the benefits referred to in paragraph 1 concerns into account to the beneficiary and the amount paid by the recipient for such benefits, including paid prepayments, appear on the voucher.
Next to each of the performed services, included with the form referred to the § 1, paragraph 1 for the services giving rise to compulsory insurance and intervention by a description for benefits not be actionable, figure the amount.
By way of derogation from paragraph 1, 1 ° and 3 ° a document shall not be granted by the general practitioner or medical specialist when he performs only a consultation or visit referred to in article 34, paragraph 1, 1 °, a), as well as in case of opening or manual extension of the global medical file. In this case, caregiver to the recipient issues a receipt for the amount received.
of beneficiary, the document contains, for the health benefits and the devices referred to in article 33, § 1, 11 ° of the law of December 15, 2013, medical devices determined by the commission of agreements or competent agreements, the amount of purchase of the features provided by the provider when they are subject to an intervention of the compulsory insurance or are part of a health benefit giving rise to such an intervention.
The conventions and agreements concluded by the committees referred to in article 26 set the endorsements listed on the voucher and the terms under which it is delivered to the recipient.
Conventions and agreements also stop the template for use by health care providers.
The documents listed in annexes 37, 38, 43, 49 and 52 of the rules of 28 July 2003 on the implementation of article 22, 11 °, of the law on compulsory insurance health care and benefits, co-ordinated on 14 July 1994, shall continue to apply until their replacement in accordance with article "6.;
(d) there shall be inserted a paragraph 1/3, as follows: "§ 1/3."
The decisions taken in pursuance of § 1 1 and § 1/2, paragraphs 5 and 6 are contained in the conventions and agreements in the form of device. They remain applicable as long they have not adapted by another agreement or another agreement.
They can be made mandatory by the King, after the opinion of the Committee on conventions or competent agreements and the Committee of the insurance.
The device of the convention or the mandatory rendering agreement is published in the Moniteur belge, annexed to the royal decree which makes it mandatory.
Mandatory rendered operative binds all the caregivers who fall within the category concerned, whether they have or not acceded to the convention or to the agreement.
The royal decree mandating the device has effect from the date fixed by the King.
The King may, after receiving the opinion of the competent Committee of conventions or agreements, abrogate totally or partially the decree having mandated the device, insofar as it stops responding to the situation and the conditions which justified the extension of the binding. (' The notice is considered have been given if it was not formulated in the two months following the request for an opinion by the Minister. "e) inserted a paragraph 1/4, as follows:" § 1/4. " For persons who, without being caregivers, take benefits giving rise to intervention by the compulsory insurance, or take benefits not giving rise to intervention by the compulsory insurance when the latter are performed with benefits that will give rise, as well as for health care providers who perform above benefits and for which there is no commission referred to in article 26 the King may take measures aimed at the transparency of the cost of healthcare to the beneficiary."
"Art. 96/1. Article 73 of the Act, replaced by the law of 24 December 2002 and amended by the royal decree of 17 September 2005 and the laws of 27 December 2005, December 13, 2006, June 8, 2008, December 19, 2008, December 22, 2008, December 10, 2009, December 23, 2009, December 29, 2010, 29 March 2012 and 22 June 2012, the following changes are made : 1 ° in the § 1, paragraph 7, the words "last paragraph" are replaced by the words "paragraph 8";
2 ° in the § 1, paragraph 7, in the Dutch version of the text, the word "mededeling" is replaced by "affichering";
3 ° a paragraph 1/1, worded as follows is added: "§ 1/1." Subject to the application of article 152, § 5, of the Act relating to hospitals and other care facilities, coordinated on July 10, 2008, the King may determine the conditions in which supplements can be applied for clinical biology, pathology and genetics services.
The King sets these conditions based on the proposal of the national medical Commission.
For the purposes of this paragraph, means supplements, the difference between the fees and the rates of the agreement in the event that an agreement referred to in section 50 is in effect or the difference between the fees and rates which serve as basis for the calculation of the intervention of insurance in case such an agreement is not in force.
S. 97. This chapter enter into force January 1, 2015.
Chapter 11 assessment and monitoring medical Arts Service
98. in article 139 of the same Act, as last amended by the law of March 29, 2012, the following changes are made: 1 ° to the paragraph 1, the words "consisting of a central service, a bilingual service for Brussels-Capital Region and ten provincial services. Bilingual service for the Brussels-Capital Region and ten provincial services are regional services within the meaning of article 32 of the law of 18 July 1966 on the use of languages in administrative matters"shall be replaced by the words"consisting of a central service and the regional services within the meaning of article 32 of the law of 18 July 1966 on the use of languages in administrative matters";
2 ° a paragraph 2 shall be inserted, worded as follows: "the King determines, by royal decree deliberated in the Council of Ministers, for regional services 1 ° their number;
2 ° their spring;
3 ° their seat. "."
S. 99. article 146, § 1, paragraph 1, of the Act, as last amended by the Act of March 19, 2013, is amended as follows: "to accomplish the mission referred to in article 139, paragraph 2, 1 ° to 5 °, the evaluation and medical control Service has a staff of inspection so that administrative staff with different grades.
Inspection staff, means: doctors-inspectors, inspectors pharmacists, nurses controllers, and inspectors with other professional qualifications.
Inspection staff is social inspector within the meaning of article 16, 1 °, of the social Criminal Code. They take oath in accordance with article 175.
Inspection staff is responsible for the whole Belgian territory, notwithstanding their administrative residence. "."
S. 100a section 146bis of the Act, as amended by the law of December 19, 2008, the following changes are made: 1 ° to paragraph 1, paragraph 2, the words "inspectors" are replaced by the words "inspection staff";
2 ° to the paragraph 1, paragraph 11, the words "doctors-inspectors" are replaced by the words "inspection staff";
3 in paragraph 2, paragraph 1, the words "the doctors-inspectors, pharmacists-inspectors and nurses-controllers" are replaced by the words "inspection staff".
S. 101. in Title VII, chapter II of the same law, the title of section II is replaced by the following: "Section II. "-The assessment and medical control Service inspection staff".
102. in article 150, paragraph 1, of the Act, as last amended by the law of March 29, 2012, "the inspectors doctors, pharmacists-inspectors, controllers nurses and social controllers" are replaced by the words "inspection of the Service of evaluation and control staff" medical.
S. 103. article 151 of the Act, as last amended by the law of May 19, 2010, is replaced by the following: "the regional director and the staff of each regional service shall be placed under the direction of two doctors-inspectors general, who are placed under the direction of physician-CEO, public servant-leader. Administrative staff in each regional service shall be placed under the direction of an administrative officer."
104. in article 152 of the Act, as last amended by the law of 24 December 2002, "doctor-Director Inspector" shall be replaced by the words "regional director".
S. 105. in article 175, paragraph 2, of the Act, as amended by the law of May 19, 2010, "the inspectors doctors, pharmacists-inspectors, nurses-controllers and social controllers" are replaced by the words "Inspection staff".
S. 106. article 98 comes into force January 1, 2015.
TITLE 3. -FAMHP Chapter 1. -Amendments to the law of 25 March 1964 on medicines Section 1st. -Objects and devices article 107. article 1bis, of the law of 25 March 1964 on medicines, inserted by the law of June 21, 1983 and amended in last lieupar the law of June 20, 2013, the following changes are made: 1 ° § 2 is supplemented by a paragraph worded as follows: "these provisions shall be adopted after the opinion of the High Council for health.";
Section 2. -Availability of medicinal arts. 108. at article 6, § 1sexies of the Act, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012, the following changes are made: 1 ° paragraph 2 is replaced by the following: "in the event of temporary or definitive cessation of the placing on the market of this medicine or in the case where the holder of authorisation is requested the withdrawal of a marketing authorisation or registration , either has not submitted request for an extension of a marketing authorisation or a registration, the authorization or registration holder shall notify also that the Minister or his delegate. Permanent cessation, this notification occurs, except in exceptional circumstances, at the latest two months before the placing on the market of the medicinal product. ';
a paragraph, worded as follows, shall be inserted between paragraphs 2 and 3: 'by derogation from paragraph 2, the notice of a termination of a pharmaceutical speciality refundable under the health care insurance, takes place at the latest six months before the placing on the market of the medicinal product.';
3 ° the existing 4 paragraph becoming paragraph 5, is supplemented by the words "including as regards the way to notify the temporary or definitive cessation of the placing on the market, the information compulsorily notifiable and period in which the temporary unavailability must be notified.".
Section 3. -Drug delivery to the public by hospital pharmacists s. 109a article 6, § 2, of the Act, inserted by the royal decree of 8 August 1997 and amended by the laws of the August 12, 2000, December 30, 2001 and December 22, 2003, the following changes are made: 1 ° in the paragraph 1, the words "for human use" are inserted between the word "drugs" and the words "to the hosted people";
2 ° in paragraph 2, the words "human use" shall be inserted between the word "drugs" and the words "for the benefit of the people";
3 ° the § is supplemented by a paragraph, as follows: "in the same way as the other pharmacists, hospital pharmacist can supply medicinal products for human use in ambulatory patients under treatment commenced at the hospital or polyclinic and medical devices in the circumstances and conditions determined by the King by Decree deliberated in the Council of Ministers." The hospital pharmacist may also issue to outpatients of orphan medicinal products and medicinal products for human use which are subject to a limited medical prescription and the issue is reserved for the hospital pharmacists in the circumstances and conditions determined by the King by Decree deliberated in the Council of Ministers. "."
Section 4. -Distribution wholesale for humanitarian purposes art. 110. article 12B of the same Act, inserted by the law of 1 May 2006 and as last amended by the Act of June 20, 2013, is supplemented by a paragraph 3, as follows: "§ § 3 3" Without prejudice of § 1, an organization approved on the basis of article 26 of the Belgian Development Cooperation Act of March 19, 2013 may operate a wholesale distribution of medicinal products for human use for humanitarian purposes that it owns.
Distribution wholesale humanitarian objective can provide medication only to organisations, institutions or associations with legal personality non-profit and similar humanitarian purpose, to distribute and to issue non-profits in Belgium, in a Member State of the Union European or another State which is a member of the economic area European , or exporting medicines to a State that is not part of the European Union or of the European economic area, to distribute and deliver non-profit with a common humanitarian goal.
By way of derogation from paragraph 2, the distribution wholesale for humanitarian purposes may issue to companies, as part of a humanitarian objective market attributed to them. For the purposes of this paragraph, the holder of the authorization for distribution wholesale for humanitarian purposes is subject to act of 15 June 2006 on public procurement and some markets works, supplies and services.
Without prejudice to the other conditions provided for in this §, the activities referred to in paragraphs 2 and 3 may only be carried out with other distributors wholesale or with pharmacists and other persons responsible for issuing to the public of medicinal products for human use in accordance with article 4 of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care. When the distribution wholesale for humanitarian purposes provides medication to persons in third countries, it ensures not deliver them to individuals who, according to the legal and administrative provisions in force in the third country concerned, are authorized or entitled to receive medication for wholesale distribution or delivery to the public.
The responsible pharmacist of the establishment of distribution wholesale humanitarian objective participates in the administration of the organization that owns the wholesale distribution.
Distribution wholesale for humanitarian purposes and the organization referred to in paragraph 1 are not subject to the contributions and fees which are collected for the acquisition and maintenance of the licences for wholesale and for the control by the FAMHP on the basis of this law and the law of 24 February 1921 regarding the traffic of poisonous substances sleeping, narcotic, psychotropic, disinfectant or antiseptic and substances that can be used in the illicit manufacture of narcotic and psychotropic substances.
The King may lay down additional rules to control activities in the framework of the implementation of the humanitarian purpose of the organization referred to in paragraph 1. "."
Section 5. -Pharmacovigilance s.
111. article 6, § 1, paragraph 9, of the Act, as amended by the law of August 3, 2012 is complemented by a sentence worded as follows: 'in the cases referred to in the second sentence, in relation to medicinal products for human use, when urgent action is needed to protect public health, at whatever stage of the procedure the Minister or his delegate may suspend the marketing Authorisations and prohibit the use of the medicinal product concerned until a definitive decision is adopted;
S. 112. article 6, § 1erquater, paragraph 2, of the Act, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012, is complemented by a sentence read as follows: "The King fixed the conditions and the detailed rules for the procedures of modification of the AMM or records.".
S. 113 A article 6, § 1erquinquies, paragraph 5, of the Act, inserted by the law of 1 May 2006, the following changes are made: 1 ° the first sentence is replaced by the following: "the instructions accompanying a drug for human use is written and designed to be clear and understandable, enabling the users to act appropriately" If necessary with the help of health professionals. ";
2 ° paragraph is supplemented by the following sentence: "the instructions accompanying a veterinary drug is drafted in terms intelligible to the general public."
S. 114 A article 6septies, § 1, of the Act, as amended by the law of August 3, 2012 and renumbered by Act of June 20, 2013, the following changes are made: 1 ° in paragraph 7, the first sentence is replaced by the following: "where a medicinal product for human use is not intended to be delivered directly to the patient, or when there are serious problems of availability of the drug , the Minister or his delegate may, subject to the measures which it considers necessary to protect human health, waive the requirement to include certain particulars on the labelling and package leaflet. ";
2 ° the § is supplemented by a paragraph, as follows: "when a veterinary drug is only intended to be administered by the veterinarian, the Minister or his delegate may waive the requirement to include certain particulars on the labelling and package leaflet of the medicinal product concerned. It may also waive the requirement of the leaflet in the three official languages. The King may fix the terms and conditions for the application of this paragraph. "."
CHAPTER 2. -Amendments to royal decree No 78 of 10 November 1967 on the exercise of the professions of health care s. 115 A article 4, § 2A, of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care, inserted by the law of 1 May 2006 and amended by the law of December 22, 2008, two paragraphs, written as follows, shall be inserted between paragraphs 2 and 3: "the exercise of the function of pharmacist in pharmacies open to the public is subject to continuous training to ensure the quality of pharmaceutical care.
The King may lay down the minimum conditions for continuing education, referred to in paragraph 3, and conditions for the control of compliance with this requirement."
S. 116. in article 21 of the same royal decree, as amended by the laws of the February 22, 1994, August 10, 2001, December 22, 2003 and July 9, 2004, the current 3 paragraph becoming paragraph 4, is supplemented by the following sentence: "the King may also determine the content and modalities of the prescription for the recognition in Belgium of prescriptions from prescribers established in another Member State and to the recognition in another State by Member of the derived requirements by prescribers in Belgium. "."
CHAPTER 3. -Modifications of the experiments on the human person article Act of May 7, 2004
117. in article 10 of the law of 7 May 2004 relating to experiments on the human person, amended by the Act of March 19, 2013, a subparagraph worded as follows is inserted between paragraphs 1 and 2: "by way of derogation from paragraph 1, the favourable opinion of a Committee of ethics with partial approval enough, if this opinion shall take account of article 11" , § 4, paragraph 1, 1 ° to 11 °, and to condition: 1 ° whether a monocentric experimental intervention as referred to in article 2, 8 °, and carried out in the context of the work required for obtaining the degree of Bachelor.
2 ° that ethics with partial approval Committee that issues the notice be tied to the site where experimentation is carried out. "."
S. 118. article 11, § 1, of the experiments on the human act of May 7, 2004, replaced by the Act of March 19, 2013, is complemented by the following sentences: "under penalty of inadmissibility of the application, in the case of a concurrent test in the application referred to in article 12, § 1, this application shall be lodged with the Minister." If the investigator does not introduce himself the folder, the folder contains, under penalty of inadmissibility, a written proxy."
S. 119. article 11, § 4, paragraph 1, of the Act, is supplemented by 12 °, as follows: "12 ° the objectives and activities of the BioBank related to testing as referred to in article 18/1, 2 °";
S. 120. in article 11, § 7, paragraph 1, of the Act, replaced by the law of March 19, 2013, the words ', on pain of unacceptability, "shall be inserted between the words"the request for an opinion is introduced"and at the same time"with the Ethics Committee".
121. article 11 of the Act, as amended by the Act of March 19, 2013, is complemented by a § 14 read as follows: "§ § 14 14 ' After the issuance of the opinion by the Ethics Committee, no new site search cannot be added during three months in accordance with the procedure relating to changes in the conduct of an experiment referred to in chapter X."
S. 122. article 11/2, § 3, paragraph 3, inserted by the Act of March 19, 2013, is replaced as follows: "the Minister refuses the approval or the extension if, during the four years preceding the application, the Ethics Committee: 1 ° either did not analyze averaged more than 25 new protocols of multicenter experiments per year as the Committee competent for the issuance of the unique notice;"
2 ° either has not scanned on average at least 40 new protocols of multicenter experiments per year in the quality of Committee competent for issuing the single opinion or nonunique notice. "."
S. 123. article 12, § 1, of the Act is replaced by the following: "§ 1." The proponent who wishes to arrange a trial in Belgium shall submit an application to the Minister by registered mail.
Under penalty of inadmissibility of the application, the proponent shall ensure that this application is lodged with the Minister concurrently pursuant to article 11, § 1, with the Ethics Committee and in consultation with the investigator. Sending concomitantly means delivery the same day mailing. "."
S. 124 § 1. In the same Act, it is inserted a chapter IX/1, which contains articles 18/1, 18/2 and 18/3, as follows: "chapter IX/1. -Special provisions for experiments in which human bodily material is obtained, where appropriate, processed, kept and made available s. 18/1. For the BioBank is created in a clinical trial and who gets exclusively human body material and, where appropriate processes, stores and makes available in the objectives and the purpose of the trial as referred to in the Protocol, the authorization as trial in accordance with article 10 applies for the duration of this test as a notification referred to in article 22 , § 1, paragraph 1, of the Act of December 19, 2008 to obtain and use of human body material intended for human medical applications or for scientific and research purposes in the following conditions: 1 ° the request to the Ethics Committee with full accreditation, as referred to in article 11, § 1, and the request to the Minister as referred to in article 12 , § 1, accompanied by form duly completed with the title: "notification of a BioBank as referred to in article 22, § 1, paragraph 1, of the law of 19 December 2008 on procurement and use of human body material intended for medical human applications or for purposes of scientific research as well as in article 18/1 of the law of 7 May 2004 relating to experiments on the human person" as published by the federal drug agency and health products. This form contains at least the following data: for the BioBank:-site from / of the deposit (s) of the human body material;
-name and business number/number of national register of the person who operates the BioBank;
-contact data of the operator (name, first name, telephone number and e-mail address);
-types of human body materials preserved and put at disposal;
About the human body material within the BioBank Manager:-name and surname;
-copy of graduates;
2 ° the objectives and activities of the BioBank subject to the favourable opinion as referred to in article 10, paragraph 1.
S. 18/2. If the Minister authorizes the trial in accordance with article 10, paragraph 2, it shall then communicate immediately to the person who introduced the form referred to in article 18/1, 1 °, the BioBank has been notified properly, indicating the number of notification if the application meets the conditions laid down by article 18/1, 1 °, and if it is aware of the positive as referred to in article 11 § 13.
S. 18/3. Manager of human body material of the BioBank as referred to in article 2, 28 °, of the law of December 19, 2008 on procurement and use of human body material intended for human medical applications or for purposes of scientific research, shall immediately communicate any changes to the form as referred to in article 18/1, 1 ° Federal Agency for drugs and health products. "."
§ 2. The § 1 shall enter into force at a date to be fixed by the King by Decree deliberated in the Council of Ministers.
S. 125. in the Act, it is inserted a chapter X/1 contains an article 20/1, as follows: 'chapter X/1. -Opinion of the Committee for medicinal products for human in case of trial, relating to the application of this law article 20/1. § 1. The Commission for medicinal products for human use, such as provided for in article 6, § 1, of the law of 25 March 1964 on medicines, hereinafter referred to as "the Commission", can give an opinion to the Minister regarding a specific test. The notice procedure is initiated at the request of the Ethics Committee that makes the unique opinion for the specific test in question.
The request for an opinion is motivated and shall state in detail the subject of further analysis. The notice may only concern the application and enforcement of the relevant test.
For specific trials, notice can only be requested if it tests:-in which an investigational drug with a novel mechanism of action is administered for the first time to the man;
-on such children as described in chapter IV and of pregnant;
-in therapeutic indications for which there is no alternative treatment.
§ 2. The jurisdiction of the Commission's opinion is limited to the assessment of risk-benefit from the application of the experimental drug, to the security of the participants in the trial, including the implementation of good clinical practice as referred to in article 4. The Commission relies to make its opinion on the scientific information quality and preclinical and clinical aspects that are made available by the proponent or that are available in scientific publications. In its opinion, the Commission refers to the specific references to relevant publications available.
The sponsor of the study concerned is informed of the proceedings.
The sponsor may be heard by the Commission at the request of the Commission or at his own request.
The Commission shall make a reasoned opinion is to the knowledge of the Minister or the applicant, as well as Ethics Committee of proponent.
§ 3. The Commission may, at the request of the Minister or of a Committee of ethics with full accreditation, render an opinion on generic aspects of clinical trials with drugs such as referred to in this law. These generic aspects relate to the safety of the participant and the principles of good clinical practices as referred to in article 4.
The Commission shall formulate an opinion on the subject within sixty days.
4. For the purposes of §§ 1 and 2, the King may establish the terms of operation of the Commission and on the conduct of the proceedings, the timetable and modalities for the hearing of the proponent, as well as the notification of the opinion. "."
-Amendments to the law of 20 July 2006 relating to the creation and operation of the Federal Agency for drugs and health products section 126. at article 4, § 1, of the Act of 20 July 2006 on the creation and the functioning of the Federal Agency for medicines and health products as last amended by the law of March 19, 2013, the following changes are made: 1 ° paragraph 3, 4 °, is supplemented by the k. and l., worded as follows: "k. controlling quality of pharmaceutical care in pharmacies open to the public;
l. inspecting veterinarians prescribing behaviour and the provision of drugs to animals officials; ";
2 ° in the paragraph 3, 6 ° e), the words "and the prescription" shall be inserted between the words "supply" and "drugs";
3 ° paragraph 3, 6 °, is supplemented by the k), as follows: "k) royal decree No. 80 of 10 November 1967 on the order of pharmacists, training continues."
CHAPTER 5. -Amendments to the law of
July 6, 2007 on medically assisted procreation and the destination of supernumerary embryos and gametes s. 127. article 26 of the law of 6 July 2007 relating to medically assisted procreation and the destination of supernumerary embryos and gametes, is supplemented by a paragraph, as follows: "for the purposes of paragraph 1, the two authors of the parental project of female that they have a common parental project are considered to be a single woman."
S. 128. article 55 of the Act is supplemented by a paragraph, as follows: "for the purpose of paragraph 1, parental project of female authors, who report having a common parental project, are considered as a single woman."
CHAPTER 6. -Amendments to the Act of December 19, 2008 to obtain and use of human body material intended for human medical applications or scientific research purposes art.
129. in article 2, 28 ° of the Act of December 19, 2008 to obtain and use of human body material intended for human medical applications or for purposes of scientific research, "doctor, the degree of doctor of medicine, surgery and childbirth carrier" shall be replaced by the words "doctor who meets the requirements laid down in article 7 of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care" (or a national of one of the Member States of the European Union who is authorized to practice medicine in a Member State other than the Belgium."
S. 130a article 7 of the Act, the following amendments are made: 1 ° the § 1, paragraph 2, is supplemented by the words "and which operates simultaneously hospital referred to in paragraph 1 or the University referred to in paragraph 1.';
2 ° paragraph 2 is supplemented by a paragraph, as follows: "the Federal drugs and health products agency publishes on its website the list of banks of body human material, of the intermediate of human body material and approved production facilities structures, indicating the type or types of human body material to which the registration relates" , and, if applicable, the operation or operations for which the establishment is approved. "."
S. 131. in section 9 of the Act, the words "article 10, §§ 1 to 6" and articles 11 to 15 are inserted between the word "provisions" and the word "du".
132. article 10 of the same Act is supplemented by a § 7, as follows: "§ § 7 7" "Without prejudice to §§ 1 to 6, and without prejudice to the law of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data, the donor or the persons referred to in §§ 3 and 4 give expressly their written consent to the possible treatment of personal data resulting from the application of this Act or its orders of execution."
S. 133. in article 13, paragraph 2, of the Act, the words "or the BioBank" shall be inserted between the words "human body material" and the words "in which".
134. under section 18 of the Act, the words "which is charged or applied in Belgium" are inserted between the words "human body material"and the words"taking into account".
S. 135 in section 22, § 1, of the same law, replaced by the law of March 19, 2013, the following changes are made: 1 ° a paragraph, worded as follows, shall be inserted between paragraphs 1 and 2: "for the BioBank is created in a clinical trial as referred to in the experiments on the human act of 7 May 2004 and who gets exclusively human body material , and appropriate processes, stores and makes available in the objectives and the purpose of the clinical trial as referred to in the Protocol, the authorization as clinical trial is for the duration of this test as a notification referred to in paragraph 1 under the conditions as referred to in the law of 7 May "2004;
2 ° in paragraph 2 becoming paragraph 3, the words "The King fixed" are replaced by the words 'without prejudice to paragraph 2, the King fixed';
3 ° a paragraph worded as follows is inserted between paragraph 2 becoming paragraph 3, and paragraph 3, becoming paragraph 4: "the Federal Agency of medicines and health products publishes on its website the list of biobanks notified pursuant to paragraphs 1 and 2. The King may establish terms and conditions for publication. ";
4 ° a paragraph, as follows, is inserted between paragraph 3, paragraph 5, and article 4, becoming paragraph 6: "in the case referred to in paragraph 2, the favourable opinion of the Committee of ethics as referred to in article 11, § 1, of the experiments on the human act of 7 May 2004, applies, in relation to clinical trial as favourable opinion as referred to in paragraph 5" , under the conditions as referred to in the Act, may 7, 2004. "."
5 ° in article 4 becomes article 7, paragraph 5, paragraph 8, and article 7, becoming subparagraph 10 "favourable opinion referred to in paragraph 3" are each time replaced by the words "favourable opinion referred to in paragraph 5";
S. 136. article 22, § 2, paragraph 1, of the Act, replaced by the law of March 19, 2013, is supplemented by the words "unless, in the case referred to in article 22 § 1, paragraph 2, these data are already reflected in the clinical trial".
S. 137. in article 22, paragraph 3, subparagraphs 1 and 2, of the Act, replaced by the Act of March 19, 2013, the word "doctor" is every time replaced by the words "doctor who meets the requirements provided for in article 7 of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care or a national of one of the Member States of the European Union who is authorized to practice medicine in another Member State" as the Belgium".
S. 138. article 45/1 of the Act, inserted by the Act of March 19, 2013, is replaced by the following: 'article 45/1. The provisions amended by the Act of March 19, 2013 bearing of various provisions (I) health and the law of the [...]
"various provisions concerning health regarding article 22, §§ 3 to 9 of this Act apply exclusively to human body material that is collected from the date of entry into force of these amended provisions."
S. 139. articles 129 to 138 come into force on a date to be fixed by the King by Decree deliberated in the Council of Ministers.
TITLE 4. -FPS public health, food chain safety and environment Chapter 1.
-Exercise of the professions of health care Section 1st. -Art Dental Arts.
140. article 3A of the royal decree No. 78 of 10 November 1967 on the practice of the professions of health care, inserted by the law of August 10, 2001 and replaced by the law of 24 November 2004, is supplemented by a paragraph as follows: "paragraph 1 applies also, for the duration of their internship, applicants to the professional titles specific to practitioners of dentistry ", whose stage plan is admissible, and up to two months at the latest after the end of their traineeship date."
Section 2. -Continuity of care article 141. article 8 of the same order, modified as last amended by the Act of December 19, 2008, is replaced by the following: 'article 8. for the purposes of articles 8A, 9 and 9A, is meant by: 1 ° deep night: the period of twenty-three hours to eight hours.
2nd normal practice time: the period from Monday to Friday from eight to eighteen hours, except holidays.
3 ° period of permanence: the period outside the normal hours of practice;
4 ° continuity of care: monitoring of treatment of patients by attending health practitioner or other health professional when health professional dealing with interrupts his practice;
5 ° medical permanence: the dispensation regular and normal healthcare to the population, during the period of permanence;
6 ° daily closure: closure of the practice of healthcare outside the normal practice schedule. "."
S. 142. in the same royal decree, it is inserted article 8bis as follows: "article 8bis. § 1. Practitioners referred to in articles 2, § 1, 3, 21A, 21quater and 21noviesdecies may not knowingly and without lawful reason in their leader, interrupt a current patient treatment without first taking all provisions to ensure the continuity of care.
The competent medical Committee shall ensure the compliance with paragraph 1 by practitioners referred to in articles 2 § 1 3, 21A, 21quater and 21noviesdecies.
By order deliberated in Council of Ministers, the King may extend or add to the list of the professions referred to in this article.
§ 2. Continuity of care is provided by another practitioner with the same specific professional title.
With regard to the practitioners referred to in article 2, § 1, the continuity of care during the deep night, with the exception of the palliative care and pain treatment, may, under conditions laid down by the King, be entrusted to the bearer of an another specific professional title reserved to holders of a diploma of doctor of medicine.
§ 3. The pharmacist may not knowingly and without lawful reason in his head, close temporarily or permanently its pharmacy without first taking all provisions to ensure continuity of the dispensation of drugs prescribed in an ongoing order.
The competent medical Committee ensures the compliance with paragraph 1.
§ 4. In the event of interruption of the treatment being a patient due to a daily closure, continuity of care can be ensured under medical permanence, as far as health care professional is involved in the Permanent medical according to the procedures laid down in accordance with article 9 "."
S. 143. article 9 of the same royal decree, as last amended by the Act of July 24, 2008, is replaced by the following: 'article 9 § 1.
The King sets the terms under which medical permanence is guaranteed.
The King may entrust missions laid down by him relating to the local organization of the medical permanence to the representation of the professionals concerned and the collaboration with other health care professionals, to representative organizations of practitioners referred to in articles 2, § 1, 3, 4, 21A, 21quater and 21noviesdecies, to groups formed for this purpose or to employers of practitioners referred to in articles 2 , § 1, 3, 4, 21A, 21quater and 21noviesdecies, provided that they are approved for this purpose.
The conditions and the procedure for obtaining of approval are determined by the Minister having health in its attributions.
None of the practitioners referred to in articles 2, § 1, 3, 4, 21A, 21quater and 21noviesdecies and satisfying the required conditions cannot be excluded from this medical service, provided that the person concerned agree to the rules of procedure and that it observes the rules of ethics.
When a permanence was established for pharmacies open to the public, all pharmacies open to the public on the role of guard participate in accordance with the rules laid down by the King.
Organisations, groups and employers referred to in paragraph 2 shall communicate to the competent medical Committee the role of guard prepared by their care as well as any changes that would be made and a rules of procedure.
The King lays down the procedures for the registration of calls during the period of permanence.
§ 2. The medical commission defines local organization of medical tenure requirements. She oversees the operation of the local medical permanence organized by organizations, groups or targeted employers in the § 1 and is authorized to approve the rules of procedure referred to the § 1 and decide disputes for the local organization of the medical permanence.
When medical permanent rules are set out in a code of ethics applicable to interested health care professionals, the commission refers in the execution of the tasks referred to in paragraph 1.
In case of deficiency or insufficiency, the medical commission is calling, initiative or at the request of the Governor of province, in collaboration with organizations, groups or targeted employers in the § 1 or interested practitioners in order to establish or to supplement the local organization of the medical permanence.
3. If at the expiry of the time limit fixed in the request referred to in § 2, paragraph 3, the local organization of the medical permanence does not satisfactorily, health inspector or, is it necessary, pharmacy Inspector himself took all measures to organize or to supplement the local organization of the permanence medical needs which will eventually defined by the Medical Committee chaired by the Governor of province. Within this framework, health inspector or, is it proclaims, the control officer of the Federal Agency for medicines and health products may require the participation of organizations, groups or employers covered in the § 1 or interested practitioners, designated by him, in order to organize or to supplement the local organization of the medical permanence. "."
S. 144. in the same royal decree, it is inserted an article 9bis worded as follows: "article 9bis. § 1. A unified system of medical attendance for the population to reach services on medical duty referred to in article 9 is established within the federal public Service health, food chain safety and environment. The King sets the minimum functioning of this system of appeal, as well as quality standards, terms of appeal and number for phone calls.
A professional organization, a group or an employer referred to in article 9, § 1, paragraph 2, could join the system of unified appeal of medical permanence.
§ 2. Professional organizations, groups or employers referred to in article 9, § 1, paragraph 2, which align themselves with the system of unified appeal of medical permanence delegate to this call system the choice of response which is made by employees of the system of appeal to the demands of patients who rely on this call system.
The unified call system officers evaluate applications for patients who rely on this unified call system and bring the medical answers the most adequate and comply with protocols of medical permanence validated by the Minister of public health.
The King may create a body or designate an existing body to propose the protocols referred to in paragraph 2.
§ 3. In compliance with the law of 8 December 1992 relative to the protection of privacy with regard to the processing of data personal and after receiving the opinion of the Committee on the protection of privacy, King lays down the procedures for the recording of calls.
These terms concern more particularly the nature of the call data to save and their structuring and assess the functioning of the system of appeal, both in respect of minimum quality standards that the Organization of a follow-up internal quality.
§ 4. The fixed King, by occupation, the date of the entry into force of this section. "."
S. 145 A section 38 of the same royal decree, as amended by the law of December 19, 2008, the following changes are made: 1 ° in the § 1, 3 ° is replaced by the following: "(3° Est puni deles de peines prévues àle 2°: a) that which, being required to participate in the local organization of the medical permanence under measures imposed in execution of article 9" § 3, does not fulfil its obligations without being able to justify a resulting hindrance of the fulfillment of a professional duty more urgent or another serious cause;
(b) any practitioner referred to in article 8A, which knowingly and without cause legitimate in his head, stop a current patient treatment without first taking all provisions to ensure the continuity of care;
(c) any pharmacist who knowingly and without cause legitimate in his head, closes temporarily or permanently its pharmacy without first taking all provisions to ensure continuity of the dispensation of drugs prescribed in an ongoing order. ";
(2 ° in § 3, the a) and b) are repealed it.
Section 3. -Kinesitherapy s. 146. in article 21B, inserted by the law of 6 April 1995 and as amended by the law of August 10, 2001, section 45, as amended by the law of December 19, 2008 and article 47, inserted by the law of 6 April 1995, of the same royal decree, "Council National de la physiotherapy" are each time replaced by the words "Federal Council of physiotherapy".
147. the article 21bis of the same royal decree, inserted by the law of 6 April 1995 and amended by the Act of 24 November 2004, the following changes are made: a) in § 4, 1 °, the words "to one of the following forms of therapy" are replaced by the words "of one or more of the following forms of therapy";
(b) in § 4, 4 °, "prenatal and post-natal gymnastics" is replaced by the words "the perinatal physiotherapy and abdomino-pelvic rehabilitation";
(c) section 6 is replaced by the following: "§ § 6 6" Persons authorised by virtue of § 1 may not exercise physical therapy for patients who are sent on the basis of a prescription is made by a person entitled to exercise the medical art under article 2, § 1, paragraph 1, or, with respect to physical therapy in case of temporomandibular dysfunction, which are sent by a person entitled to practise dentistry under article 3.
This requirement is written, possibly electronically or by fax. It indicates the diagnosis or the elements of diagnosis established by the physician, or where appropriate the practitioner of dentistry, the maximum number of treatment sessions by the physiotherapist and possible contraindications for certain treatments.
It may also indicate the services requested by the physician, or where appropriate by the dental practitioner.
With the agreement of the prescribing physician, or if any of the dental practitioner, physiotherapist can accomplish other benefits than those prescribed or to abstain to achieve the prescribed benefits.
At the request of the prescriber, or if any of the dental practitioner, physiotherapist shall forward a report on the realization of the treatment and the results obtained.
"The King may determine the list of reasons and situations in which persons authorised by virtue of § 1 may waive the condition referred to in paragraph 1."
S. 148. in article 21B of the same royal decree, § 7, inserted by the law of 6 April 1995 and amended by the law of January 25, 1999 and August 10, 2011, is replaced by the following: "§ § 7 7" The King regulates the organisation and functioning
federal Council of physiotherapy.
It can only deliberate validly if half at least of its full members are present or are represented by their alternate. If the members of the federal Council of physiotherapy are not present in sufficient numbers, the president shall convene a second meeting with the same agenda. The Board can validly deliberate irrespective of the number of members present.
The Council shall decide by a majority of the members present.
In the event of parity of votes, which was submitted to the vote was not adopted.
The decisions of the Council are, in relation to the notices referred to in article 47, § 1, taken by a majority of two-thirds of the members referred to in § 4, paragraph 1, 1 ° and 2 °, provided that this majority includes at least one Member referred to in § 4, paragraph 1, 2 °. "Section 4. -Midwives s. 149. in section 21quater of the same royal decree, amended and renumbered by the law of 6 April 1995, § 2 is replaced by the following: "§ § 2 2" The bearer of the professional title of midwife, who graduated prior to October 1, 2018, may exercise full nursing under the same conditions as holders of the professional title of graduated nurse.
The bearer of the professional title of midwife who graduated after October 1, 2018, can full right to carry out technical services nursing and medical care acts falling within the nursing, in the field of obstetrics of the fertility treatment art, Gynecology and neonatology. "."
150. in section 1erquater of the same royal decree, it is inserted an article 21noviesdecies/1 as follows: "article 21noviesdecies/1. § 1. It is created a commission on accreditation for midwives with the federal public Service health, food chain safety and environment.
§ 2. The commission on accreditation for midwives has for mission to render an opinion on applications for approval of midwives to bear the professional title, as well as to render an opinion on the registration of permanent training. It also has mission to monitor compliance with the conditions laid down by the Minister that public health in its attributions, for the maintenance of the relevant title, and to propose to the Minister of sanctions where, in the case of control, it is established that these conditions are not met.
§ 3. The King rule the composition, organization and functioning of the commission on accreditation for midwives. "."
Section 5. -Professions allied health articles 151. in the Dutch text of article 22A of the same royal decree, inserted by the law of 19 December 1990, "stelt stelt" shall be replaced by the word "stelt".
S. 152. in article 28 of the same royal decree, "Ministry of public health and family" shall be replaced by the words 'Federal public Service health, food chain safety and environment'.
S. 153. in article 30 § 1, paragraph 1, of the same royal decree, as amended by the law of August 10, 2001, 6 °, is replaced by the following: "6 ° and two officials who will act as Secretary and under-Secretary;".
S. 154. article 35bis of the same royal decree, inserted by the law of 19 December 1990, is replaced by the following: 'article 35A. § 1.
A technical Commission of the paramedical professions shall be established with the federal public Service health, food chain safety and environment.
This commission has the mission to give the notice referred to in article 46bis, § 2.
§ 2. The commission comprises equal numbers of representatives of paramedical professions and representatives of the art of healing, appointed by the King. The King also appoints an alternate for each of these representatives.
§ 3. The King appoints a Chairman and a Vice-Chairman on the technical Commission proposal.
The president of the meeting sits without voting. If the president is a member of a paramedical profession, it can be represented by its alternate member who then vote right. If the vice-president is a member of a paramedical profession and shall serve as Chair of the meeting, it may be represented by his substitute, who then vote right.
The secretariat is provided by an official designated by the Minister having health in its attributions.
§ 4. Subject to §§ 2 and 3 and paragraph (2), the King sets the composition, organization and operation of the technical Commission of the paramedical professions.
The commission deliberates validly when half of the representatives of the paramedical professions and half of the representatives of the art of healing professions are present. It shall take its decisions by a majority of two-thirds of the votes of the members present and at least the majority of the votes of each group.
When during a meeting of the Commission, half of the members of each group is not present, the commission may validly deliberate on the same agenda points at the next meeting, regardless of the number of members present. In this case it takes its decisions by a majority of three-quarters of the votes. "."
Section 6. -Planning art. 155. in the same royal decree, the title of chapter IIbis, replaced by the law of 29 January 2003, is replaced by the following: "chapter IIbis. -Professional qualifications specific, individual professional titles, master of the offer, end of career, evaluation, structure and organization of the practice, bodies and permanent federal data bank of health care professionals"art. 156. the introductory sentence of article 35octies, § 2A, paragraph 3, of the same royal decree, inserted by the Act of 29 January 2003, is supplemented by the words "permanently".
S. 157. in article 35quaterdecies, §§ 1, 4, 5 and 6, of the same royal decree, amended last amended by the law of March 29, 2012, the word "permanent" is each time inserted between the words "Federal data bank" and the words "health care professionals".
Section 7. -Commissions medical art. 158 A article 36, of the same royal decree, as last amended by the Act of December 19, 2008, the following changes are made: 1 ° § 2 is replaced by the following: "§ § 2 2" Each medical commission is composed of: 1 ° the Chairperson, doctor;
2 ° a Vice President, physician;
3 ° two members by profession referred to in articles 2, § 1, 3, 4, § 1, 21A, 21quater and 21octiesdecies.
4 ° two veterinarians;
5 ° one member per profession referred to in the present order, other than the professions referred to in articles 2, § 1, 3, 4, § 1, 21A, 21quater and 21octiesdecies.
6 ° a member by unconventional practice registered as referred to in the Act of 29 April 1999 on unconventional practices in the areas of medical art, pharmaceutical art, physiotherapy, nursing and paramedical professions;
7 ° a health inspector of the federal public Service health, food chain safety and environment.
This health inspector is the Secretary of the commission;
8 ° a staff member of the inspection of the Federal Agency for medicines and health products. ";
2 ° in § 3, the words "sub 3 ° to 8 ° of § 2 of this article" shall be replaced by the words "referred to in § 2, 3 ° to 6 °,";
3 ° in § 4, the words "full and alternate referred sub 3 ° to 8 °" are replaced by the words "full and alternate referred to in § 2, 3 ° to 6 °" and the words "Member referred sub 9 ° and 10 ° of the §" are replaced by the words 'the members referred in § 2, 7 ° and 8 °'.
S. (159 A section 37 of the same royal decree, as amended by the law of December 19, 2008, the following changes are made: 1 ° in the § 1, 2 °, b), paragraph 1, "what a professional of health care covered by this order or a veterinarian" shall be replaced by the words "a health care professional under this order ", a veterinary surgeon or a member of a non-conventional practice recorded and referred to in the Act of 29 April 1999";
(2 ° in the § 1, 2 ° c), 1., the words 'the medical art and the pharmaceutical art, veterinary art therapy, nursing and paramedical professions' are replaced by the words "the professions of health care covered by this order, veterinary, and unconventional practices recorded and referred to the law of 29 April 1999 supra";
3 ° in the § 1, 2 ° c), 2, the words "of the medical art, pharmaceutical art, veterinary art, nursing or allied health professional art therapy" are replaced by the words "professions of health care covered by this order, veterinary, and unconventional practices recorded and referred to in the Act of 29 April 1999 supra";
4 ° in the § 1, 2 °, e), the words "by a practitioner of medical, pharmaceutical art, veterinary art, nursing or a member of a paramedical profession or by a physiotherapist" are replaced by the words "by a professional from the healthcare covered by this stopped, a veterinary surgeon or a member of a practice unconventional recorded and referred to the law of 29 April 1999 supra";
5 ° in the § 1, 2 °, h), the words "for professionals health care covered by this order or a veterinary doctor," are replaced by the words "for the professionals of the healthcare covered by this order, a veterinarian or a
Member of a non-conventional practice registered and referred to in the Act of 29 April 1999 ";
6 ° § 2 is replaced by the following: "§ § 2 2" For the performance of its overall mission, the medical commission consists of members referred to in article 36, § 1, 1 ° to 8 °.
For the accomplishment of its mission, the Medical Committee consists only of president, Vice-President, Secretary, or members representing the profession of the interested person or the Member representing the registered unconventional practice referred to in the Act of 29 April 1999 of the interested persons. "."
Section 8. -Care by entourage arts. 160. in article 38ter of the same royal decree, as last amended by the Act of March 19, 2013, 1 ° is supplemented by a paragraph worded as follows: "it is no application for the person who is part of the entourage of the patient and which, apart from the exercise of a profession, at the end of training issued by a physician or a nurse" According to a procedure or a plan of care established by the latter, receives permission to perform with this specific patient one or several technical benefits referred to in article 21quinquies, § 1, b). A document issued by the doctor or the nurse indicates the identity of the patient and the person receiving the permission. This document also shows the technical services authorized, the duration of the authorisation and any additional conditions laid down by the doctor or the nurse to perform the technical services. "."
Section 9. -Leisure arts.
161. article 49bis, § 2, of the same royal decree, inserted by the law of 22 February 1998, is supplemented by two paragraphs worded as follows: "where the application concerns the exercise of a profession related to the possession of a diploma for nursing, the application is submitted prior to the opinion of the commission on accreditation for nursing practitioners.
Where the application concerns the exercise of a profession related to the possession of a diploma of midwife the application is submitted prior to the opinion of the commission on accreditation for midwives. "."
CHAPTER 2. -Assists medical urgent s.
162. article 3ter of the law of July 8, 1964 on emergency medical assistance, inserted by the law of July 24, 2008, is replaced by the following: 'article 3B. within the limits of the budget appropriations, a subsidy is allocated to ambulance services referred to in article 5 for the Organization of permanence and the modalities and the conditions laid down by the King. "."
Chapter 3 amendment of the Health Act, on September 1, 1945, s. 163. in the Health Act of 1 September 1945, it is inserted an article 4/1 as follows: "article 4/1. The King determines the amount of payments that may be required for the implementation of the activities of inspection and control under the health inspection of ships and aircraft, as well as the time limits and procedures of their perception. "."
CHAPTER 4. -Hospitals Section 1st. -Preservation of records s. 164. in article 20, § 1, of the coordinated law of July 10, 2008, on hospitals and other care facilities, the words "in the hospital" are each time be replaced by the words "by the hospital".
S. 165. in article 25, § 1, of the Act, renumbered by the royal decree of June 19, 2009, "to hospital" shall each time be replaced by the words "by the hospital".
Section 2. -Management and structure medical arts. 166. article 18 of the Act, as amended by the Act of March 19, 2013, is supplemented by two paragraphs worded as follows: "the chief physician is invited and can assist with advisory capacity, in the meetings of the body which, under the legal status of the hospital, is responsible for the management of the operation of the hospital.
Section 6 does not apply when the discussions relate to matters for which the chief physician is personally and directly concerned. "."
S. 167. in article 22 of the Act, the following changes are made: 1 ° in paragraph 2 the words "the Chief doctor and the Chief Medical Officer's service are appointed or designated" are replaced by the words "the chief physician is named or designated";
2 ° article is supplemented by a paragraph written as follows: "Unless otherwise provided for in the regulations referred to in article 137 (2), the Chief Medical Officer's service is named or appointed for a renewable period of six years.".
Section 3. -Equipment heavy art. 168. article 56 of the Act is replaced by the following: "the professional practitioner who operates a machine or equipment of medical imaging or treatment communicates to the Minister who was in charge of the public health, the data set by the King by Decree deliberated in the Council of Ministers. The King determines devices for which data are to communicate and the period in which this communication must take place. "."
Section 4. -Financing of the costs of exploitation art.
169. in section 95 of the Act, paragraphs 2 and 3 are repealed.
S. 170. article 121 of the Act is repealed.
Section 5. -State articles aid 171. Article 105, § 1, paragraph 1, of the same law, the a) is supplemented by the words "which cannot last more than ten years, except for the components of the budget of the financial resources that cover significant investment costs of the hospital requiring, in accordance with generally accepted accounting principles, amortisation over a longer period".
S. 172. article 108 of the Act is supplemented by a paragraph, read as follows: "notification to the project manager of decision and the final decision, as referred to in paragraph 1, contain a reference to the Decision of the Commission on December 20, 2011 on the application of article 106, paragraph 2, of the Treaty on the functioning of the European Union to state aid in the form of public service compensation granted to certain undertakings entrusted of la" operation of services of general economic interest."
Section 6. -Resolution of disputes art. 173. in article 139, § 2, paragraph 4, of the Act, the words "chosen from a list of mediators drawn up by him, on a proposal from the National Commission joint doctors-hospitals" are replaced by "chosen from a list proposed by the National Commission joint doctors-hospitals".
-Rights of the patient art. 174. in the Act of 22 August 2002 on the rights of the patient, amended by the acts of 24 November 2004, December 13, 2006, 17 March 2013 and May 23, 2013, it is inserted an article 8/1, as follows: ' article 8 / ' 1. the professional practitioner shall inform the patient if he has or not coverage of insurance or another individual or collective professional liability protection. "."
S. 175. "in the same Act inserted an article 8/2, as follows: ' article 8 /" " 2. the professional practitioner shall inform the patient of its Statute to perform authorization or registration. "."
S. 176. at article 16, § 2, of the Act of 22 August 2002 on the rights of the patient, the following changes are made: 1 ° 4 ° is supplemented by the words "and to make recommendations in this regard;";
2 ° 5 ° is repealed.
CHAPTER 6. -Advertising art. 177. the title of the Act of 23 May 2013 regulating the qualifications for non-surgical aesthetic medicine and cosmetic surgery, acts is supplemented by the words: "and regulating the advertising and information relating to such acts.".
S. 178. in article 2, 1 °, of the same law, them words "are included in the devices using any form of energy for devices using laser class 4 or higher or intense pulsed light" are repealed.
S. 179. article 2 of the Act is supplemented by 6 ° to 9 ° written as follows: "6 ° advertising: any form of communication or action to the public that is intended, directly or indirectly, to promote the provision of the acts referred to in article 3, regardless of the location, the medium or technology used, including reality shows;"
7 ° professional information: any form of communication which aimed, directly and specifically, regardless of location, support or the techniques used to publicize a practitioner or to give information on the nature of his practice.
8 ° misleading information: any form of communication or action which, in a way, including its presentation, misled people to whom it is addressed or whom it reaches and which, because of its deceptive nature, may affect their behaviour or which, for those reasons, injures or may be detrimental to a patient;
9 ° comparative information: any form of communication or action which explicitly or by implication identifies another practitioner or service offered by another practitioner. "."
180. article 3 of the same Act is supplemented by a paragraph 2 as follows: "Do not fall under the application of this Act tattoos, piercings and hair removal techniques.".
181. article 15 of the Act is repealed.
S. 182. in the Act, it is inserted a chapter 6/1 as follows: "Chapter 6/1. -Publicity and information".
S. 183. in section 6(1) of the Act, inserted by article 172 article be inserted a 20/1, as follows: "article 20/1, it is prohibited to any physical or legal person of broadcast advertising relating to the acts referred to in article 3.
The professional information related to these acts is
authorized in accordance with the conditions set out below.
Professional information must be in accordance with reality, objective, relevant, verifiable, discrete and clear.
This information shall not be misleading, comparative and cannot use financial arguments.
Professional information always mention the profession specific within the meaning of section 35b of the royal decree No 78 of 10 November 1967 on the practice of the professions of health care available to the practitioner.
When the professional information is broadcast by an institution that employs the services of practitioners, the names of practitioners as well as the professional titles specific within the meaning of section 35b of the royal decree No 78 of 10 November 1967 on the exercise of the professions of health of each of them are always mentioned.
The provisions of this Act relating to the advertising and professional information does not prejudice the application of the Act of 22 August 2002 on the rights of the patient insofar as it seeks information on the acts referred to in this Act. "."
S. 184. in Chapter 7 of the Act, it is inserted an article 22/1 as follows: "article 22/1. One who commits an offence referred to in article 20/1, shall be punished by a term of imprisonment from eight days to six months and a fine of two hundred and fifty five thousand euro EUR or one of those penalties only.
In addition, the Court may order the publication of the judgment or the summary at the expense of the offender through three newspapers and any other way. "."
S. 185. under article 24 of the Act, the following amendments are made: 1 ° in the § 2, paragraph 1, the words "minimum theoretical training in non-surgical aesthetic medicine and" are inserted after the words "may justify";
2 ° in § 2, paragraph 2, the words "one year" are replaced by the words "of two years";
3 ° in § 3, the words "one year" shall be replaced by the words "two years".
S. 186. in article 24 of the same Act, § 5 is repealed.
S. 187. in article 25 of the Act, the number "2014" is replaced by "2015".
CHAPTER 7. -Animals, plants and Food Section 1st. -Amendments to the Act of January 24, 1977 relating to the protection of the health of consumers with regard to foodstuffs and other products article 188 A article 10 of the Act of 24 January 1977 on the protection of the health of consumers in what concerns foodstuffs and other products, amended by the Act of February 9, 1994 and the royal decree of February 22, 2001, the following changes are made: 1 ° paragraph 3 is replaced by the following : "The amount of these fees is payable, on behalf of the Federal Agency for the safety of the food chain, or to the budgetary Fund of the raw materials and products";
2 ° article is supplemented by a paragraph worded as follows: "The King is empowered to modify, replace or repeal the provisions of the royal decree of 13 November 2011 fixing the fees and contributions due to the budgetary funds of the raw materials and products.".
S. 189 A section 11 of the Act, as amended by the Act of 27 December 2011, the following changes are made: 1 ° the § 1 is replaced by the following: "s.11. § 1.
Without prejudice to the powers of the judicial police officers, members of the staff or contractor of the federal public Service health, food chain safety and environment designated for this purpose by the King oversee the implementation of the provisions of this Act and its orders of execution as well as regulations of the Union European and which fall within the competence of the Service public federal public health Food chain security and environment by conducting unannounced inspections, with exhibits of their duties that are established by the King.
Members of the contract staff shall take oath, prior to the exercise of their functions, in the hands of the Minister or his delegate.
Members of staff statutory or contractual of the federal public Service health, food chain safety and the environment appointed by the King for the monitoring of the application of this Act and orders made pursuant to it may, within the limits of the execution of their competence, enter, without prior warning, in all places affected trade in foodstuffs or other products regulated by this Act and in adjacent to these places deposits and other places under their control or in which they may have reasonable cause to assume that there are violations of the provisions of the laws which they exercise monitoring. They can search, even if these are not accessible to the public.
They can penetrate without prior warning, at any time, in places that are used in the manufacture of foodstuffs or other products covered by the Act and for trade, as well as in the premises where they are stored.
The visit to the premises solely residential is permitted only between 5 a.m. and 9 p.m. and it can be carried out there with the permission of the judge.
They may require the production of all writings and commercial documents relating to foodstuffs and other products regulated by this Act and all documents required by the orders made pursuant to this Act.
They can undertake the control of transport, transit and means of transport. ";
2 ° in § 2, paragraph 3, the words "10 days" are replaced by the words "thirty days";
3 ° § 2 is supplemented by paragraphs 5 and 6 worded as follows: "they can proceed with the sealing of automatic distribution machines which are not in conformity with article 6 §§ 4 and 6.
They can carry out any review, control and hearing and collect any information they deem necessary to ensure that the provisions of the laws which they exercise monitoring are actually observed and take the identity of any person which they consider necessary audition for the monitoring exercise. "."
S. 190. in the introductory sentence of article 13 of the same Act "twenty-six to three hundred francs" shall be replaced by the words "twenty-six thousand euro EUR".
S. 191. in article 14 of the same Act, replaced by the law of December 27, 2012, "fifty to a thousand euros" shall be replaced by the words "fifty euros to three thousand euros".
S. 192. article 16 of the act as amended by the Act of 22 December 2003, is replaced by the following: 'article 16. without prejudice to the application of the penalties provided for by articles 269-274 of the penal Code, is punishable by imprisonment from 15 days to three months and a fine of one hundred to two thousand euros or one of those penalties only, one who is opposed to the visits, inspections, investigations, controls, hearings, consultations of documents, samples, gatherings of evidence or to the seizure or by persons authorized to search to find the offences to the This Act and the orders made in implementation or the regulations and decisions of the European Union, as well as one who opposes, who insults the above-mentioned persons and refusing to present an official identification document. "."
S. 193 A section 19 of the Act, as amended by the law of December 27, 2012, the following changes are made: 1 ° in the paragraph 1, the words "Department of public health and the environment" shall be replaced by the words 'Federal public Service health, food chain safety and environment';
2 ° paragraph 2 is replaced by the following: "the amount of the sum to be paid cannot be less than half the minimum or exceed the maximum fine for the offence.";
3 ° paragraph 6 is replaced by the following: "the sum is paid to the budgetary funds of raw materials and products.".
-Amendment of the law of 28 July 1981 approving the Convention on international trade of species of wild flora and fauna threatened with extinction, and schedules, made in Washington on 3 March 1973, as well as the amendment to the Convention, adopted in Bonn on June 22, 1979, s. 194. article 4bis, § 1, of the Act of 28 July 1981 approving the Convention on international trade of species of fauna and flora threatened with extinction, and schedules, made in Washington on 3 March 1973, and the amendment to the Convention, adopted in Bonn on 22 June 1979, inserted by the law of 24 December 2002 , is supplemented by a paragraph worded as follows: "The King is empowered to modify, replace or repeal the provisions of the royal decree of 13 November 2011 fixing the fees and contributions due to the budgetary funds of the raw materials and products.".
Section 3. -Amendment of the law of 20 July 1991 amending of the social provisions and various arts. 195 article 132 of the Act of 20 July 1991 concerning social and various provisions, replaced by the Act of March 1, 2007, and amended by the Act of June 8, 2008, is supplemented by a paragraph worded as follows: "The King is empowered to modify, replace or repeal the provisions of the royal decree of 13 November 2011 fixing the fees and contributions due to the budgetary funds of the raw materials and products.".
Amendment of the Act of 22 December 2009 establishing general regulations for banning smoking in enclosed places accessible to the public and the protection of workers against the smoke of tobacco art. 196. in section 2 of the Act of 22 December 2009 establishing general regulations for banning smoking in enclosed places accessible to the public and the protection of workers against the tobacco smoke, partially annulled by judgment No. 37/2011 March 15, 2011, of the Constitutional Court, 11 ° and 12 ° shall be repealed.
S. 197. in the Act, it is inserted an article 9/1 as follows: "article 9/1. In addition to the penalties provided for in article 9, the Court may order the closure, for a period of one month to six months, of the closed place accessible to the public where the offences have been committed. "."
PHILIPPE by the King: the Minister for Affairs social and public health, Ms. L. ONKELINX the Secretary of State for Social Affairs, families and persons with disabilities responsible for occupational risks, Assistant to the Minister of Social Affairs and public health, and State Secretary for science policy, Assistant to the Minister of Social Affairs and public health , Ph. COURARD sealed with the seal of the State: the Minister of Justice, Ms. A. TURTELBOOM _ Note (1) House of representatives (www.lachambre.be): Documents: 2013/2014-0 - 53-3349 full report: March 13, 2014 Senate (www.senate.be): Documents: 2013-2014 - 53-2740 annals of the Senate: April 3, 2014