Source: https://www.global-regulation.com/translation/belgium/3032061/miscellaneous-provisions-act-%2528i%2529-health.html
Timestamp: 2018-10-17 03:27:04
Document Index: 287428535

Matched Legal Cases: ['art.\n2', 'art. 3', 'art. 4', 'Art. 5', '§ 1', 'art. 7', '§ 12', '§ 2', 'art. 10', '§ 1', 'art. 12', '§ 2', 'Art.\n13', '§ 3', '§ 3', '§ 3', 'art. 14', 'art. 15', '§ 2', 'Art. 16', '§ 1', '§ 2', 'Art. 20', '§ 3', '§ 1', '§ 1', '§ 2', 'art. 23', '§ 1', 'art.\n24', 'art. 137', '§ 1', '§ 2', '§ 3', '§ 4', '§ 5', '§ 1', '§ 1', '§ 4', '§ 1', 'art. 38', '§ 3', '§ 4', '§ 2', '§ 2', '§ 1', '§ 2', '§ 1', '§ 2', '§ 3', '§ 4', '§ 1', '§ 1', '§ 2', '§ 4', '§ 1', '§ 2', '§ 1', '§ 1', '§ 1', '§ 2', '§ 2', '§ 1', '§ 1', '§ 2', '§ 1', '§ 2', '§ 1', '§ 1', '§ 1', '§ 3', '§ 2', '§ 2', 'art.\n79', '§ 3', 'art. 80', '§ 1', '§ 1', 'art. 85', '§ 1', 'Art. 87', '§ 2', 'art. 88', '§ 4', '§ 3', '§ 1', '§ 2', '§ 4', '§ 4', '§ 7', '§ 4', '§ 4', '§ 1', '§ 2', '§ 4', '§ 1', '§ 2', '§ 3', '§ 2', '§ 4', '§ 5', '§ 4', 'art.\n102', '§ 1', 'art. 104', '§ 1', '§ 2', '§ 1', '§ 3', '§ 2', '§ 5', '§ 5', '§ 5', '§\n2', '§ 1', '§ 1', 'Art. 111', '§ 1', 'Art. 113', '§ 1', '§ 1', '§ 1', '§ 1', '§ 3', '§ 1', '§ 3', '§ 4', '§ 5', '§ 7', '§ 8', '§ 9', '§ 1', '§ 1', '§ 1', '§ 2', '§ 2', '§ 3', 'art. 124', '§ 1', '§ 2', '§ 4', '§ 5', '§ 6', '§ 7', '§ 8']

Machine Translation of "Miscellaneous Provisions Act (I) Health" (Belgium)
Miscellaneous Provisions Act (I) Health
Original Language Title: Loi portant des dispositions diverses en matière de santé (I)
Read the untranslated law here: http://www.ejustice.just.fgov.be/cgi/article_body.pl?numac=2013024113&caller=list&article_lang=F&row_id=1300νmero=1309&pub_date=2013-03-29&dt=LOI〈uage=fr&fr=f&choix1=ET&choix2=ET&fromtab=+moftxt&trier=publication&sql=dt+=+'LOI'&tri=pd+AS+RANK+
Posted the: 2013-03-29 Numac: 2013024113 PUBLIC SERVICE FEDERAL public health, food chain safety and environment March 19, 2013. -Miscellaneous Provisions Act health (I) ALBERT II, King of the Belgians, to all, present and to come, hi.
CHAPTER 2. -Amendments to the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994 Section 1st. -Obligation to register art.
2. in title I of the law on compulsory health care and compensation insurance co-ordinated on 14 July 1994, it is inserted an article 9terredige as follows: «art.» 9B. subject to the application of article 165, paragraphs 7 and 10, and in respect of the consultation procedures provided for by this Act, by Decree deliberated in the Council of Ministers after the opinion of the Committee on the protection of privacy, the King may make reimbursement of certain health benefits referred to in article 34, paragraph 1 , the condition to the registration of specific data relating to these benefits.
This record is a dispensation of care to beneficiaries faster and more efficient control of quality and cost of care or scientific research. ' Section 2. -Commission scientific art. 3. in article 20 of the Act, replaced by the royal decree of 25 April 1997 and amended by the law of December 22, 2008, the words "deliberated in the Council of Ministers" are repealed.
-Agreements art. 4. in article 42 of the Act, amended by laws of 20 December 1995, 22 February 1998 and 19 December 2008, a paragraph worded as follows is inserted between paragraphs 1 and 2: "conventions referred to in the previous paragraph also apply, as regards the provisions relating to tariffs, to people who receive health care under a regulation of the European Union or the Treaty on the functioning of the European Union or a. Convention on social security. » Art. 5. article 50, § 1, of the same law is supplemented by a paragraph worded as follows: "the above agreements also apply with regard to the provisions relating to tariffs, to people who receive health care under a regulation of the European Union and the Treaty on the functioning of the European Union or a convention on social security.»
Section 4. -Midwives s.
6. article 74 of the Act is replaced by the following: «art.» 74. the specialist doctor, dental practitioner or midwife shall inform the doctor dealing with the patient's consent, the Protocol of examinations that he practices. When the medical consultant of the organism insurer, as part of its control, actually requested, it shall forward a copy of this Protocol.
However, if the medical specialist, dental practitioner or midwife considers it necessary, it is seeking the patient's consent. » Section 5. -Offices of pricing art. 7 ÷ article 165, paragraph 10, of the same Act, replaced by the law of August 10, 2001 and amended by the law of April 8, 2003, the following changes are made: 1 ° «prescribers» shall be replaced by the word «prescribers»
2 ° 'analysis of the interaction between practitioners and medical specialists when prescriptions are issued by different doctors' shall be replaced by the words "the analysis of the interaction between care providers in cases where the requirements are issued by different providers.
Section 6. -Reference amounts s. 8 ÷ article 56ter of the Act, inserted by the Act of 22 August 2002, replaced by the law of December 19, 2008 and amended by the law of December 10, 2009, the following changes are made: 1 ° in paragraph 11, 1 °, the words "has been certified" are inserted between the words "(acetabulum and femoral head)" and the words "and APR - DRG 302."
2 ° article is supplemented by a paragraph 12 as follows: ' ' § § 12 12 For admissions that end after December 31, 2012, paragraphs 1 to 10 and paragraph 11, 2 ° to 9 °, shall apply subject to the following conditions: 1 ° diagnosis APR - DRG 190 group is divided into groups of diagnostic APR - DRG 190 - circulatory disorders with myocardial infarction 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 - circulatory disorders with myocardial infarction if the admission takes place in a hospital that has, during the year of application, of a programme of care B or B1 alone or in combination;
2 ° groups diagnostic APR - DRG 45, APR - DRG 46, APR - DRG 139 and APR - DRG 302 are divided into groups of diagnostic APR - DRG 45 - stroke with infarction of the brain, 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 46 - stroke non-specific with precerebrale without infarction of the brain occlusion 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 139 - pneumonia simple, 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 - major Interventions on joints affiliation of members of the lower extremities without trauma if the nomenclature code 289085 - Arthroplasty of the hip with total prosthesis (acetabular and femoral head) has been documented, 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 - major Interventions on joints , incorporation of members of lower extremities without trauma, if the code of nomenclature 290286 - tibio-femoral with articulated prosthetic Arthroplasty was attested 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 with infarction of the brain, if the admission takes place in a hospital that , 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 - stroke non-specific with precerebrale occlusion without myocardial infarction of the brain 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 - pneumonia simple, 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 - major Interventions on joints, connecting members of the lower extremities without trauma, if the code of nomenclature 289085 - Arthroplasty of the hip with total prosthesis (acetabular and femoral head) has been certified 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 - major Interventions on joints, connecting members of the lower extremities without trauma, if the code of nomenclature 290286 - tibio-femoral with articulated prosthetic Arthroplasty has been certified if the admission takes place in a hospital that , during the year of application, concluded with the Insurance Committee no convention revalidation of disorders (neuro) locomotives (7.71 or 9.50). "Section 7. -Management joint s.
9. article 213, § 2, paragraph 2 of the Act be replaced by the law of 22 February 1998, is supplemented by the following: ", on the understanding that, in the context of the implementation of the health care insurance, article 15 of the Act of April 25, 1963 is applicable to the Insurance Committee and the general Council.". In this case, it is sufficient that one of the two bodies to issue an opinion on the project concerned.
» Section 8. -Statute of limitations art. 10. article 174, paragraph 1, 9 °, of the Act, as amended by the law of 20 December 1995 and 26 March 2007, is supplemented by the following: «However, for contributions owed by the holders referred to in article 32, paragraph 1, 15 °, the action for repayment of the personal contributions paid unduly shall lapse five years after the end of the month to which they relate.»
Section 9. -Council on accreditation s.
11. in article 215, § 1, of the Act, amended by the law of 22 February 1998 and December 24, 1999, the words "article 34, 1 °, c), 4 ° and 7 ° bis» are replaced by the words" in article 34, bis paragraph 1, 4 °, excluding the provision of hearing aids, 4 ° bis and 7 °.. "Section 10. -Conventions and agreements art. 12. in article 49 of the same Act, amended by the Act of 20 December 1995, the royal decree of 16 April 1997 and laws on February 22, 1998, 24 December 1999 and 19 December 2008, paragraph 2 is replaced by the following:
« § 2. The agreements may provide that the commission in which the convention was entered into is competent to reconcile disputes that may arise concerning the interpretation or execution of the conventions and that the commission can take the opinion of the competent technical advice when the dispute relates to the interpretation of the nomenclature. » Art.
13. ÷ section 50 of the Act, the following amendments are made: has) in the § 3A, inserted by the Act of 1 March 2007, "without prejudice to the provision of § 3, last subparagraph' shall be replaced by the words"without prejudice to the provision of § 3, paragraph 8. "
(b) in section 7, the following changes are made: 1 ° 1st paragraph is repealed;
2 ° in paragraph 2 old, becoming the single paragraph, the word 'They' shall be replaced by the words "Agreements" and the word "also" is repealed.
Section 11. -Advertising art. 14. in article 127 of the Act, as amended by the law of 24 December 1999, paragraphs 2 and 4 to 9 are repealed. Paragraph 3 becomes paragraph 2.
Section 12. -Control medical art. 15. article 142, § 2, of the Act, restored by the law of December 13, 2006 and replaced by the law of March 29, 2012, is complemented by six paragraphs worded as follows: 'aforementioned officials joining the certified report an invitation to proceed voluntarily with full refund of the amount of the value of the benefits unduly attested in charge of health care insurance.
Total reimbursement shall be by payment to the account of the Institute no later than within two months as of the day following notification of the certified report.
If the amount is less than or equal to 3,000 euros, the total reimbursement causes the extinction of administrative proceedings and the case is closed.
If the amount to be repaid is greater than 3,000 euros, the refund total does not result in the termination of administrative proceedings and shall not preclude the application of the measures referred to in paragraph 1. The same applies if a new record of observation is notified within three years from the invitation to undertake the voluntary refund, regardless of the total amount to be repaid.
Any refund made is recorded as revenue of the health care insurance.
The invitation to perform voluntary reimbursement suspends foreclosure timelines in paragraph 3. » Art. 16. in article 143, § 1, 1 °, of the same Act, repealed by the law of 24 December 2002, restored by the law of December 13, 2006 and replaced by the law of March 29, 2012, the «25 000» is replaced by «35 000» sales
17. in article 146, paragraph 2, of the Act, as amended by the laws of 25 January 1999, December 24, 1999, August 12, 2002, 24 December 2002 and on 13 December 2006, paragraph (2), is repealed.
18 ÷ article 169 of the Act, replaced by the Act of February 15, 2012, the following changes are made: 1 ° in the paragraph 1, the words "Act, orders and regulations of execution and to the conventions and agreements under this same Act" are added after the words 'implementing regulations '.
2 ° in paragraph 2, the words "Act and its orders and regulations" are replaced by the words "Act, of its orders and regulations of execution, conventions and agreements under this Act.
Section 13. -Financial responsibility of insurers s. 19. article 196, § 2, of the Act, replaced by the law of July 24, 2008, is supplemented by a paragraph 4 as follows: "(the King may, by Decree deliberated in the Council of Ministers, delegate to the general Council for subsets parameters it defines, referred to in paragraph 1: a) the modification of these parameters;
b) adding additional parameters. » Art. 20. article 197, § 3A of the Act, inserted by the law of 14 January 2002 and amended by the law of December 23, 2009, is complemented by sections 2 to 4 worded as follows: "are also neutralized means financial, included in the overall budgetary objective in the context of the implementation of measures that have a positive financial impact, which are not fully used because the date of actual implementation of the measures is posterior to the. date of implementation laid down in the overall budgetary objective.
The general Council determines what are these amounts in the first quarter following the year for which the global budgetary target was set based on a comparison of the dates of implementation of measures that have a positive financial impact such as they are, on the one hand, in the overall budgetary objective and such as they are, on the other hand, in the journals technical estimates provided in article 38 paragraph 4. The dates of implementation of measures that have a positive financial impact are updated in the journals technical estimates provided for in article 38, paragraph 4, until 31 December of the year for which the global budgetary target was set.
Where the general Council already decided to deduct a portion of the amounts of the financing needs of the Institute pursuant to article 197, § 1, paragraph 3, provided neutralization in paragraphs 2 and 3 apply only to the part of amounts which exceed the already deducted part. "Section 14. -Care dental arts. 21. in article 35, § 1, paragraph 2, of the Act, replaced by the law of August 10, 2001 and amended by law of August 22, 2002 and August 5, 2003, a sentence written as follows shall be inserted between the second and the third sentences: "(with regard to the benefits referred to in article 34, paragraph 1, 1 °, e), the King may determine in the nomenclature the parameters on the basis of which it can limit to a maximum the. number of benefits attestable during a specified reference period. "Section 15. -Small surgical equipment Art. Artikels 22 ÷ article 37 of the same Act, last amended by the Act of 27 December 2012, it is inserted a 2/1 paragraph as follows: "§ 2/1. For health benefits referred to in article 34, paragraph 1, 4 ° bis, that are provided to beneficiaries hospitalized, including in the case of hospitalization of day, the King may provide specific rules relating to the intervention of the health care insurance and the personal intervention of the beneficiaries.
The benefits referred to in paragraph 1 may be reimbursed on the basis of a fixed amount per admission.
The personal intervention may consist of a fixed amount per admission at charge of the beneficiaries referred to in paragraph 1.
The King may determine that the intervention of the insurance and the personal intervention referred to in paragraphs 2 and 3 are only planned for the beneficiaries referred to in paragraph 1 which have undergone a medical intervention on the list of the benefits referred to in article 34, paragraph 1, 3 °, that fixed it.
The overall budget of the fixed amounts referred to in paragraph 2 shall be established annually by the general Council, after receiving the opinion of the Committee on budgetary control, and is divided, if necessary, following the rules to be determined by the King. The Insurance Committee is responsible for the processing of disputes, according to the procedure laid down by the King.
Hospitals cannot, for the cost of the benefits referred to in paragraph 1, wear into account other amounts dependants of beneficiaries than the personal intervention as it is determined by the King. "Section 16.
-Third fee art. 23. in article 53, § 1, paragraph 9 of the same Act, inserted by the law of December 27, 2012, 'medical benefits' shall be replaced by the words "health benefits" in the french text.
CHAPTER 3. -Modifications of the programme law (I) of 24 December 2002 single Section. -Sample permanent art.
24A article 278 of the programme law (I) of 24 December 2002, amended by the law of 27 December 2005 and December 19, 2008, the following changes are made: 1 ° in article 5, first sentence, which begins with the words "the King, after", which ends with the words "by Canadian insurers.' is replaced by the:"the King can. , after opinion of the Committee on the protection of private life, allow the Agency intermutualiste to constitute a representative sample of 1/40 insured that are affiliated or registered with insurers, referred to in paragraph 1, complete by 1/40 insured persons aged 65 and over as well as a reference file that indicates what policyholders are part of the household for which the maximum charge is applied by insurers. »;
2 ° in paragraph 5, the last sentence, which begins with the words "the King, after" and ends with the words "sample representative permanent.», is replaced by the phrase:"the King may, by order deliberated in Council of Ministers and after receiving the opinion of the Committee on the protection of privacy, register the intermutualiste Agency and other organizations or associations having management and search missions and/or assessment and control missions laid down by law or under the law, to support the policy of health, in the list of organizations that have access to the permanent representative sample. »;
3 ° in article 8, in the Dutch text, the words «intermutualistisch» and «kenniscentrum» are respectively replaced by the words «Intermutualistisch» and «Kenniscentrum. "
4 ° article is supplemented by three paragraphs, worded as follows: 'it is hereby established a technical commission.
that fixed what practical and qualitative criteria the availability of sample files must meet and which verifies compliance with these quality criteria. These quality criteria focus on the representativity of the sample, the completeness of the data, the permanent accessibility and continuity of technical support. The commission also controls the measures that are taken to prevent the identification of insured persons in the sample and gives its approval to the convention which concluded in this context with an intermediary organization within the meaning of 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. The commission shall report its activities annually to the general insurance Council of health care and to the Commission on the protection of privacy.
The commission is composed of two representatives of the Commission on the protection of privacy, two representatives of the intermutualiste Agency and two representatives from each agency that has access to the sample files. The commission is chaired by the supervising official of the Service of the national Institute for sickness and invalidity insurance health care or the person designated by him for that purpose. The commission shall establish an internal regulation that stipulates its rules of operation.
The personal data contained in the permanent representative sample, may permanently or may not be supplemented by or correlated with other data available outside the framework of the permanent representative sample, following the details and modalities in the enumeration below: 1 ° subject to evaluation and monitoring carried out by physicians supervisors of the Intermutualiste Agency regarding the possible increased risk of identification , and after approval by the technical commission, the personal data contained in the permanent representative sample can be supplemented by statistical without personal data or indicators of demographic and socio-economic nature drawn from sets of data available either within or outside the intermutualiste Agency. Additional data concerns anonymous data within the meaning of article 1, 5 °, 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. The add-in is done on the basis of a common variable to the permanent sample and above data sets, which does not involve an identification of physical persons.
The result of this completion is unable to identify the insured concerned.
2 ° upon authorization of the sectoral Committee of social security and of health, personal data contained in the sample representative permanent can be correlated permanently with other personal data that insurers have in the performance of their legal duties.
3 ° in a unique and temporary study whose purpose fits into the legal missions of agencies that have access to the permanent representative sample, the sectoral Committee of social security and health or other relevant sectoral Committee, may authorize the correlating of data contained in the permanent representative sample with other personal data whose insurers do not have.
4 ° If the aforementioned studies present a recurring character or if, pursuant to policy, it is considered useful to correlate the above data on a permanent basis legal missions of a body with access to the permanent representative sample, the King may authorize, by Decree deliberated in the Council of Ministers and after receiving the opinion of the Committee on the protection of privacy to give to the agency concerned a permanent access to the aforementioned correlated personal data.
The King sets the terms and conditions related to this permanent access. This permanent access and its control is attributed to the respective supervisors and security advisors doctors the Intermutualiste Agency and the body concerned, and by mutual agreement and under their shared responsibility and making accounts to the technical commission. If the Agency Intermutualiste receives a permanent access to the personal data correlated above, a doctor monitoring and a Security Advisor of one of the organizations that have access to the permanent representative sample are designated for the supra control.
CHAPTER 4. -Changes in the programme act of 20 July 2006 single Section.
-Second pillar of pensions s. 25. article 55 of the programme law of July 20, 2006, amended by laws on December 27, 2006, 22 December 2008 and 29 December 2010, is completed as follows: 'from 2012, an amount of 904.653 euros was transferred from the national Institute for sickness and invalidity insurance to the national Office for Pensions for the benefit of the workers with a contract of employment with an employer in the public sector. An amount of 8.083.660 euros was transferred to the sectoral savings in the Federal sectors for the benefit of the workers with a contract of employment with an employer in the private sector.
These transfers are made in June of each year.
From 2013, these amounts are adapted annually to the evolution of the value of the average arithmetic of the health index in the month of June and indices of prices for the previous three months between June 30 of the penultimate year and June 30 of the previous year. The report expressed by these developments is rounded to the fourth digit after the decimal point, upwards if the fifth digit is at least 5, if not down. ».
S. 26. article 25 is effective January 1, 2012.
CHAPTER 5. -Creation of a service "Funds of Medical Accidents" (FAM) within the national Institute of health insurance - invalidité (INAMI) Section 1.
-Changes to compensation for damage resulting from s. health care Act on March 31, 2010 «27. in section 2 of the Act of March 31, 2010 on compensation of damage resulting from health care, 10 ° is replaced by the following: «10 °» Fund»: the special service of the national Institute of health insurance disability referred to in article 137ter of the law on compulsory health care and compensation insurance co-ordinated on 14 July 1994;
S. 28. in the same Act, the title of Chapter 3 is replaced by the following: "Chapter 3. -The tasks of the Fund of medical accidents.
S. 29. articles 6, 7 and 9 to 11 of the Act are repealed.
Section 2. -Amendments to the law on compulsory insurance health care and benefits, co-ordinated on 14 July 1994, s. 30. article 1 of the law on insurance compulsory health care and benefits, co-ordinated on 14 July 1994 is complemented by the following sentence: "It also establishes a system of compensation for medical accidents resulting from health care and organizes it in a separate sector relative to compensation for medical accidents.".
S. (31A article 2 f), of the same Act, replaced by the law of 24 December 2002, the following changes are made: 1 ° after the words 'medical control', the word 'and' is replaced by a comma;
2 ° after the words "administrative control", the words "and the Fund for Medical Accidents"; are added.
S. "' 32. in article 13 of the same Act, replaced by the law of 29 April 1996 and amended by the law of June 17, 2009, the words ', VIbis» are inserted between the words" in titles III, IV "and the words"and VII ".
S. 33. in the Act, it is inserted a VIbis title, with sections 137ter to 137sexies, as follows: 'title VIBIS. -OF compensation for damages resulting from care of health chapter 1. -INSTITUTIONS Section 1. -Service "Funds of Medical Accidents" (FAM) art. 137ter. There is established within the Institute, known as "Fund of Medical Accidents", abbreviated FAM, a service responsible for administration of compensation for damages resulting from health care and the application of the Act of March 31, 2010 on compensation of damage resulting from health care.
From the date of the entry into force of this chapter VIbis, service resumed and continued all the Medical Accidents Fund missions defined by the Act of March 31, 2010.
Without prejudice to the law of March 31, 2010 supra and this Act, the King determines the rules relating to the Organization and the operation of the service.
The staff of the service framework allows it to have the skills necessary for the performance of its tasks, including medical and legal.
The members of the Management Committee and of the staff of the service, as well as all employees permanent or occasional, are held to professional secrecy.
No other service or agents of another service of the Institute may request or access or receive information about folders and individual cases or the persons concerned by them and treated by the service, even for or the exercise of the tasks of this service.
Section 2. -Committee of management of the arts service 137quater. § 1. The 'Medical Accidents Fund' service is managed by a Management Committee.
§ 2. The Management Committee is composed as follows:
1 ° four members representing the authority;
2 ° four members representing organisations of all employers and the representative organizations of self-employed workers;
3 ° four members representing organisations of all workers employed;
4 ° four members representing the organizations insurers;
5 ° five members representing professional practitioners, including three doctors at least;
6 ° three members representing the institutions of health care, including at least a medical officer of health;
7 ° four members representing patients;
8 ° two professors or lecturers of law, medical law.
So many members of francophone and Dutch-speaking members include Management Committee and each group represented in its midst. To judge whether this last condition is fulfilled, the representatives of professional practitioners and health-care institutions are regarded as a single group.
The president and the vice-president are a different linguistic role.
§ 3. The King set the mode of designation of the members. By Decree deliberated in the Council of Ministers, he called the president, the vice-president and the members for a renewable term of six years.
He may, under the conditions it determines, appoint alternate members. It sets out the amounts of the allowances and tokens of presence of the president, the vice-president and the members of the Management Committee.
§ 4. Without prejudice to the law of March 31, 2010 supra and this Act, the King lays down the rules of operation of the Management Committee.
§ 5. A maximum number of three Government Commissioners, appointed by the King on presentation respectively of the Minister who has Affairs in charge, the Minister who has public health in its attributions and the Minister who has the Budget in charge, attend meetings of the Management Committee.
S. 137quinquies. service management Committee: 1 ° manages, with the service and its Director general, the tasks determined by the Act on March 31, 2010;
2 ° stop accounts and establishes the budget for compensation of damage resulting from health care as determined by the Act on March 31, 2010;
3 ° propose the budget for the administrative expenses of the service to the general Committee;
4 ° gives a notice to the general Committee on the annual proposal of framework for the service personnel;
5 ° is informed by the Director general of the service's procedures for procurement related to the missions of the service or its management, and especially those whose Management Committee a delegation of Deputy Head of the Institute;
6 ° shall establish its rules of procedure and submits it for approval to the King.
CHAPTER 2. -Arts funding 137sexies. § 1.
For the performance of its tasks and its administrative expenses, the service is funded by: 1 ° an annual amount, to the costs of administration of the national Institute for sickness and invalidity insurance, set by the King, by Decree deliberated in the Council of Ministers, on the basis of the budget drawn up by the Management Committee of service and administrative costs proposed by the Committee of management of the service to the general Committee.
2 ° income of subrogatory actions carried out in accordance with articles 28, 30, 31 and 32 of the Act of March 31, 2010;
3 ° the financial products gathered on the amounts available to the Service;
4 ° the claims due to the service under articles 15, paragraph 6, and 31, paragraph 6, of the Act of March 31, 2010.
Funding determined in the § 1, 1 °, includes the amounts needed in the budget of the missions and to the budget of the administration of the service fee. ».
S. 34 A section 177 of the Act, replaced by the law of 29 April 1996 and amended by the laws of the January 14, 2002, December 24, 2002 and April 8, 2003, the following changes are made: 1 ° in paragraph 2, after the words "health care" the word "and" is replaced by a comma;
«2 ° in paragraph 2, the words"and a Managing Director of the Fund of medical accidents ' shall be inserted between the words"a director general compensation service,"and the words" as well as a doctor and CEO of Service.".
S. 35A section 182 of the Act, replaced by the law of 29 April 1996 and amended by the Act of January 14, 2002, the following changes are made: 1 ° in paragraph 3, the words "as well as Executive Director of the Fund for medical accidents referred to in § 4," are inserted between the words "in §§ 1 and 2," and the words "attend meetings";
2 ° article is supplemented by a paragraph 4 as follows: "Executive Director medical accidents fund referred to in article 177, paragraph 2, is responsible for executing the decisions of the Committee of management of the service of the medical accidents Fund, in accordance with the authority granted to it under article 181, paragraph 7
He attends the meetings of the Committee of management of the service of the Fund of medical accidents and ensures the secretariat.
He attends the meetings of boards and commissions that work within the service of law or it may be represented by an official designated by him. ».
S. 36. article 183 of the same Act, replaced by the law of 29 April 1996 and amended by the law of May 19, 2010, is supplemented by a paragraph as follows: 'the medical director general of evaluation and control medical and Executive Director of the Service of the administrative control referred to in the preceding paragraphs, attend the meetings of the general Committee.'
S. 37A section 192 of the Act, replaced by the royal decree of 12 August 1994 and amended by the law of December 27, 2012, the following changes are made: 1 ° 1st paragraph is replaced by the following: 'The Institute has the resources referred to in articles 137sexies and 191.';
2 ° paragraph 3 is supplemented by the following sentence: 'he attributed to the relative sector to compensation for medical accidents resources referred to in article 137sexies and it will be charged on the total amount of these resources the amount of its administrative expenses contained in the budget document referred to in article 12, 4 °, for the part relating to this sector.';
3 ° paragraph 4 is supplemented by the 3 ° as follows: «3 ° to the industry in connection with compensation for medical accidents: the resources referred to in article 137sexies after removal of the administration fee for the part relating to this sector.»
Section 3. -Other necessary changes art. 38. in article 1, 3 °, of the law of 22 July 1993 laying down certain measures for public service, the words '-the Fund of medical accidents "are repealed.
S. 39. in article 1 of the Act of 16 March 1954 relating to control of some public interest organizations, are removed in alphabetical order, in category B, the words 'medical accidents Fund.
S. 40. the King is empowered to take any other provisions necessary to ensure the integration of the Fund within the NIHDI, applicable in repealing, amending, or supplementing statutory provisions, by royal decree deliberated in the Council of Ministers. These orders are confirmed within 12 months of their publication in the Moniteur belge. Failing this, they cease to have effect.
Section 4. -Transitional provisions and entry into force article 41. as to transitional measure, the royal decree of October 12, 2011, determine the rules relating to the Organization and operation of the Fund of medical accidents, shall continue to apply to the Fund and its bodies, to the extent of its compatibility with the new organization planned and this as long as it is not made pursuant to articles 137ter, § 3, and 137quater, § 4, of the law on insurance compulsory health care and allowances co-ordinated on 14 July 1994 added by this Act.
S. 42 are application to the Management Committee set up by article 137quater of the law on compulsory insurance health care and benefits co-ordinated on 14 July 1994, introduced by this Act, the following rules: 1 ° as a transitional measure, the Government Commissioners already appointed to the Fund under the Act of March 31, 2010 supra continue their mandate to the Management Committee;
2 ° as a transitional measure, members full and alternate of the Board of Trustees of the Fund for medical accidents established by the Act of March 31, 2010, who are in office on the date of the entry into force of this Act, continue their mandate as members of the Management Committee.
S. 43. the entry into force of this chapter shall be no earlier than January 1, 2013. If the publication of the Act takes place after that date, the entry into force of this chapter shall be the first day of the month following publication.
CHAPTER 6. -Hospitals Section 1st.
-Corrected article 44 A section 18 of the Act to hospitals and other care facilities coordinated July 10, 2008, amended by the law of December 10, 2009, the following amendments are made: 1 ° in article 2, 2 °, the phrase "by way of derogation from paragraph 1, 2 °, pharmacists or dismissed in chemical sciences which, in accordance with article 5, § 2, of the Decree royal No. 78 of 10 November 1967 on the practice of the professions of health care are empowered. to perform analyses of clinical biology, cannot become head of Department of the clinical biology laboratory. "is repealed;
2 ° article is supplemented by a paragraph worded as follows:
' By way of derogation from article 2, 2 °, pharmacists or dismissed in chemical sciences which, in accordance with article 5, § 2, of the Decree royal No. 78 of 10 November 1967 on the practice of the professions of health care are entitled to carry out analyses of clinical biology, can be appointed or designated head of a laboratory of clinical biology. ''
Section 2. -Confirmation of the royal decree of July 10, 2008, on the coordination of the law on hospitals and other care institutions, as amended by the royal decree of 19 June 2009 amending the royal decree of July 10, 2008, on the coordination of the law on hospitals and other institutions of care article 45. the royal decree of July 10, 2008, on the coordination of the law on hospitals and other care facilities, such as amended by order royal 19 June 2009 amending the royal decree of 10 July 2008 concerning coordination of hospitals and other care facilities Act, is confirmed.
S. 46. the title of the Act relating to hospitals and other care facilities, coordinated on July 10, 2008, is replaced by the following: "Act coordinated on hospitals and other care facilities.
Section 3. -Composition of the national Council of settlements hospital s. 47 article 33 of the same Act, a paragraph worded as follows is inserted in between paragraphs 1 and 2: "pursuant to paragraph 1, are present within the national Council of hospital facilities and medical competence as nurse competence.»
Section 4. -Deficit of formerly public hospitals s. 48. article 125 of the Act is supplemented by two paragraphs worded as follows: ' by way of derogation from paragraph 1, 1 ° and 2 °, the deficit of the hospital under public status, become a hospital under status since the year in which the deficit has been fixed, is not brought to the attention of the financial institution that manages the accounts of Government subordinate to the amounts of the deficit in the accounts of those authorities who previously ran the public hospital Office. If there is an agreement written between the hospital, which became private, and the subordinate administration that previously managed the public hospital, at the end of which it is formally determined that no further intervention in the coverage of deficits for a period prior to the change in status of the hospital concerned is to be granted by the subordinate administration manager of the hospital, formerly public, from the date of the change of status of the hospital concerned.
In this case, the statutes of the private hospital and a copy of the written agreement are sent to the Minister having health in its attributions. ».
Section 5. -S. hospital budgets 49. in section 118 of the Act, the words 'entered in the budget of the federal public Service health, food chain safety and environment' are replaced by the words "paid by the national Institute for sickness-disability insurance, from the budget of the cost of administration of the said Institute.
CHAPTER 7. -Data electronic Section 1st. -eCare s.
50 A section 37 of the Act of August 21, 2008 to the institution and the Organization of the eHealth platform, the following changes are made: 1 ° 1st paragraph is supplemented by the following sentence: ' association also aims to promote and support for application development projects which, through the sharing and exchange of data from health care providers. , are intended:-to increase the quality and continuity of health care ensuring permanent availability of relevant health data to the patient;
-to optimize collaboration and communication between health care providers to improve the monitoring of a patient. »;
2 ° in article 3 (2), the word "these" is replaced by the word "its";
3 ° paragraph 3 is supplemented by the 4 ° to 8 ° worded as follows: '4 ° to promote collaboration and transparency, to inventory the available applications as well as applications for recording projects, sharing and exchange of health data, maintain a list of these applications and projects, documenting the models used to communicate any information related to these applications and projects and their status as well as to constitute an interface to promote interoperability, if necessary, between the different projects and applications;
5 ° to promote the interoperability of projects, to express themselves on the appropriateness and the scope of the projects submitted, at the request of a member, or at the request of a public institution which finances or who plans to finance these projects, to assess their feasibility, objectify their cost and control consistency between projects;
6 ° to promote transparency and uniformity of the rights and obligations of stakeholders through various projects and applications, to ensure governance as aspects of content concerning the registration, the sharing and exchange of health data, both in regards to data flows between providers that flows of medico-administrative data; to make recommendations on the establishment of the therapeutic relationship, regarding the categories of care stakeholders who will be empowered by categories of data to be used in whole or in part these data about the patient's informed consent and the right of scrutiny of the patient on the use of its data.
7 ° in the interests of harmonisation of the projects funded by a public institution or for which a request for funding was introduced, ensure governance regarding the operational aspects concerning the registration, the sharing and exchange of health data;
8 ° to propose to the eHealth platform of the criteria with which individual computerized records or shared folders must comply, so that healthcare providers can obtain the right to use. These criteria may relate to aspects concerning the use of these applications or technical aspects such as the Organization of databases, the Organization of data flows and the collection of anonymous, coded data. ».
Section 2. -Force probative s. 51. in the law of 24 February 2003 concerning the modernization of the management of social security and regarding electronic communication between businesses and the federal authority, it is inserted an article 4/1 as follows: «art.» 4/1. A signature using the electronic identity card (e - ID) is equated to a handwritten signature. ».
52. in the same Act, it is inserted a section 4/2 as follows: «art.» 4/2. § 1. A service that allows to send by registered, by means of information technology, a signed document electronically to a citizen, an employer or his representative, hereinafter named the recipient, to the intervention of the Crossroads Bank for social security, can be made available.
To this end, the Crossroads Bank for social security uses computer techniques which: has) guarantee the origin and integrity of the contents of the shipment through appropriate security techniques;
(b) allow to correctly identify the sender and properly determine the moment of shipment;
(c) provide that the sender, where appropriate upon enquiry, receives proof of shipment or delivery of the shipment to the consignee.
The sectoral Committee of social security and health social security section approves these computer techniques.
The communication between the sender and the receiver takes place via a secure mail box, which is put at the disposal of the citizen, the employer or his representative via the network of social security. This mailbox is the official communication channel for e-mail messages sent between the sender and the recipient.
§ 2. Communication that meets the conditions referred to in the § 1 has the same probative force as a registered letter or a registered letter sent by mail. ».
53. in article 3 of the same Act, the § 2A and § 3, paragraph 2, are repealed.
54. in the Act article 2A is supplemented as follows: "7 ° offer a service within the meaning of article 4/2 of the Act of 24 February 2003 concerning the modernization of the management of social security and electronic communication between businesses and the federal authority.".
55. in the Act, it is inserted an article 14bis, as follows: «art.» 14A. the social data electronically, to the intervention of the Crossroads Bank, or to social or persons security institutions to which all or part of the rights and obligations arising from this Act and its implementing measures has been extended in accordance with article 18, as well as their reproduction on a readable medium, have the same probative force than they would have if they were communicated on paper.
Social data which are communicated by electronic means, without any intervention of the Crossroads Bank, by or in institutions of social security in the cases referred to article 14, paragraph 1, 1 °, 2 °, 3 ° and 5 °, as well as their reproduction on a readable medium, have the same probative force than they would have if they were communicated on paper. ».
Section 3. -Amendments to the Act of August 21, 2008 to the institution and the Organization of the eHealth platform
S. 56. the title of the Act of August 21, 2008 to the institution and the Organization of the eHealth platform is replaced by the following: "the institution and the Organization of the eHealth platform Act and containing various provisions.
S. 57. in the same Act, it is inserted an article 8/1 as follows: "article 8". 1 care providers that are associated in person in the execution of acts of diagnosis, prevention or care of a patient are allowed for the identification of the persons concerned, to preserve the folder is associated identification number, referred to in article 8 of the law on the Crossroads Bank for social security of the patient and persons to which the personal data are treated in the medical record of the patient in the aforementioned acts and use this number in the reciprocal exchange of their personal data or when the Exchange with others who are allowed to use the identification number.
Trade referred to in article 1 are carried out in accordance with the law of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data, in particular pursuant to articles 5 and 7.
The care provider who, in accordance with paragraph 1, preserves an identification number referred to in article 8 of the law on the Crossroads Bank destroyed this identification number at the latest at the time of the destruction of the record concerned in accordance with the applicable regulations.
If the exchanges referred to in paragraph 1 of the present article are executed electronically, they are made using either the eHealth platform basic services, which offer guarantees equivalent to the level of security of the information and services that are subject to specific control of the sectoral Committee of social security and health. ».
S. 58. article 15, § 4, of the Act is supplemented by three paragraphs worded as follows: "with the exception of the person responsible for the daily management of his Deputy and holders of the remaining management functions, staff is appointed, promoted and dismissed by the Management Committee in accordance with the rules of the staff regulations.
The Management Committee may submit to Ministers of the proposals for amendment of laws or orders that it is responsible for implementing. If a proposal has not been gathering unanimously the report to Ministers exposes the different opinions expressed. The Management Committee can also send Ministers to the opinions on all legislative proposals or all amendments legislation that the Committee is responsible for applying and before Parliament.
Except in an emergency, Ministers shall submit the opinion of the Management Committee any draft legislation or draft regulatory decree to amend the legislation or regulations that the eHealth platform is responsible for administering or concerning the plan of personnel and the structure of the eHealth platform. The Management Committee gives its opinion within the time limit of one month.
At the request of Ministers, this period may be reduced to ten days. If the Ministers call upon the emergency, they shall inform the Chairman of the Management Committee. ».
S. 59. in the Act, it is inserted an article 36/1 as follows: «art.» 36/1. § 1.
Electronic data that is managed in the context of implementation of the policy of health referred to in article 5, § 1, I, of the Special Act of institutional reforms of 8 August 1980, so that their reproduction on paper, have the same probative force than that they would have had if they were communicated on paper where the following conditions are met
: 1 ° the electronic data indicate the identity of the author of these data, authenticated either using a procedure whose methodology has been approved by the sectoral social safety and Health Committee, either by using the identity certificate present on the electronic identity card or a certificate complying with the provisions of the law of 9 July 2001 laying down certain rules for the legal framework for electronic signatures and certification services;
2 ° electronic data can be combined so precise a reference date and time assigned reference either by the eHealth platform, referred to in article 2 of the law of August 21, 2008 relative to the institution and the Organization of the eHealth platform, or by another body determined by the King by Decree deliberated in the Council of Ministers after consultation with the sector Committee of social security and health;
3 ° the electronic data can no longer be changed imperceptibly after the mention of the identity of the editor referred to the 1 ° and the association to a reference date and an hour of reference referred to in 2 ° in accordance with a procedure which the methodology was approved by the sectoral Committee of social security and health;
4 ° the electronic data meet, insofar as they have been established by several persons, the requirements referred to in 1 °, 2 ° and 3 °, for each editor in regards to data it has established;
5 ° the electronic data can be read at least during the period imposed by the applicable rules.
§ 2. The King may, after notice of the eHealth platform, determine under what conditions the data stored, processed, or transmitted using photographic and optical techniques, as well as their reproduction on paper or on any other medium readable, have, for application in health care, the same probative force as the original data. ».
S. 60. article 58 produces its effects on October 23, 2008, insofar as a third paragraph is inserted in article 15, § 4, of the Act.
Section 59 is effective January 1, 2012.
CHAPTER 8. -Amendments to royal decree No 78 of 10 November 1967 on the exercise of the professions of health care s. 61. in the royal decree No 78 of 10 November 1967 on the practice of the professions of health care, it is inserted an article 21quinquiesdecies/1 worded as follows: «art.» 21quinquiesdecies/1. It is forbidden to any caregiver a way to give any support or assistance to a third party not qualified in order to permit it to operate one or more nurses allowed to nurse. ».
62. in the same royal decree, it is inserted a section 21quinquiesdecies/2 as follows: «art.» 21quinquiesdecies/2. No person shall assign to people whom even volunteer, he holds the professional title referred to in article 21quinquiesdecies, if these people do not meet the conditions laid down by articles 21quinquiesdecies and 21septiesdecies. ».
S. 63. in article 21septiesdecies, § 1, paragraph 1, of the same royal decree, inserted by the law of August 10, 2001 and amended by the law of December 19, 2008, "Section 21quindecies" shall be replaced by the words 'article 21quinquiesdecies.
S. 64. in the same royal decree, it is inserted an article 21duovicies as follows: «art.» 21duovicies. it is forbidden to any first aid-ambulance to lend in a way any sound assistance or assistance to a third unqualified in order to enable the latter to carry out one or more activities falling within the profession of first aid-ambulance.
S. 65. in the same royal decree, it is inserted an article 21tervicies as follows: «art.» 21tervicies. zero cannot assign to people whom even volunteer, he holds the professional title referred to in article 21vicies, if these people do not meet the conditions laid down by article 21vicies. ».
S. 66A article 38ter of the same royal decree, inserted by the law of December 20, 1974 and amended by the law of 6 April 1995 and August 10, 2001, the following changes are made: 1 ° in the introductory sentence, the words ' as is it should, the application of disciplinary sanctions "shall be inserted between the words"penalties provided by the penal Code"and «» ', is punished.
2 ° in 1 °, paragraph 2, the words ", rescuers – paramedics ' shall be inserted between the words"nurse"and the words"and physiotherapy practitioners. "
3 ° in 1 °, paragraph 3, the words "or first aid-ambulance" shall be inserted between the words 'paramedic' and the words 'exercising the above-mentioned activities ";
4 ° in the 4th, the words ', the registration referred to in article 21vicies' shall be inserted between the words "of the approval referred to in article 21quater" and the words "or registration referred to in article 21quinquiesdecies."
5 ° in 5 °, the words "or article 21vicies' shall be inserted between the words" of persons referred to in article 21quater "and the words", the completion»;»
6 ° article is supplemented by the 8 ° to 13 ° worded as follows: «8 ° one who does meet the conditions laid down in articles 21quinquiesdecies and 21septiesdecies, carries out one or more activities in nursing art permitted to nurse in accordance with article 21sexiesdecies, § 2, and more specifically, one who carries out one or more activities as referred to in article 21quinquies, § 1. ((a), with the intention to make a financial profit, or habitually carries one or more activities as referred to in article 21quinquies, § 1, b).
This provision shall not apply to persons entitled to practise medicine.
or midwives, practitioners of nursing art, rescuers – paramedics, practitioners of physical therapy or a paramedical profession, with regard to the regulatory practice of their profession.
She is not more application in the medical student, the student midwife to the student in physiotherapy and the person a paramedical training or first aid-ambulance carrying the above during his training or speaking in student activities the above through a recognized training activities for obtaining the approval referred to in article 21quater, § 1, or the registration referred to in article 21quinquiesdecies;
9 ° the caregiver who, in contravention of article 21quinquiesdecies/1, ready in a way any his collaboration with a third party or it serves as nominee, for the purposes of the intention of avoiding sanctions punishing the illegal practice of the health profession;
10 ° the caregiver who exercises in violation of orders taken in pursuance of article 21sexiesdecies, § 2;
(11 ° person who, without the registration referred to in article 21vicies, pursues one or more activities in nursing art licensed to the profession of paramedic first aid in accordance with article 21unvicies, § 2, and more specifically, one who carries out one or more activities as referred to in article 21quinquies, § 1, has), with the intention to make a financial profit, or habitually carries one or more activities as referred to in article 21quinquies ((, § 1, b) and (c)).
This provision shall not apply to persons entitled to practise medicine, midwives, practitioners of nursing, carers, practitioners of physical therapy or a paramedical profession, with regard to the regulatory practice of their profession.
12 ° the ambulance first aid which, in contravention of article 21duovicies, ready in a way any his collaboration with a third party or it serves as nominee, for the purposes of the intention of avoiding sanctions punishing the illegal practice of the profession of first aid-ambulance;
13 ° the first aider ambulance which exercises in violation of orders taken in pursuance of article 21unvicies, § 2. ».
S. 67A article 38quater of the same order, inserted by the law of December 20, 1974 and amended by the law of 6 April 1995, the following changes are made: 1 ° in the introductory sentence of paragraph 1, the words ' as is it should, the application of disciplinary sanctions "shall be inserted between the words"penalties provided by the penal Code"and the words «» ', is punished.
2 ° in the paragraph 1, 1 °, the words ", in article 21quinquiesdecies or article 21vicies" are inserted between the words "section 21septies" and the words ", assigns itself publicly."
3 ° in the paragraph 1, 2 °, the words ', article 21quinquiesdecies/2 or in article 21tervicies"shall be inserted between the words"section 21novies"and the words", assigns ".
S. 68 A section 39 of the same Decree, as amended by the laws of the December 19, 1990, 6 April 1995, 17 March 1997 and December 19, 2008, the following changes are made: 1 ° in the introductory sentence, the words ' as is it should, the application of disciplinary sanctions "shall be inserted between the words"penalties provided by the penal Code"and «» , shall be punished;
2 ° in 1 °, paragraph 2, the words ", article 21quinquiesdecies, article 21vicies" are inserted between the words "one of the securities provided for in article 21quater" and the words "or article 23, § 1.
3 ° in 1 °, paragraph 3, the words ', caregiver or first aider ambulance "are inserted between the words" nurse practitioner "and the words" who performs under his profession of acts'.»»»»»
S. 69. in article 43, § 2, 1 °, of the same Decree, replaced by the law of December 20, 1974 and amended by the law of 25 January 1999, the words "or chapter Ierquinquies" are inserted between the words "Chapter Ierter" and the words "herein".
70. in article 49bis, § 1, of the arrested, inserted by the law of 22 February 1998 and amended by the Act of December 13, 2006, the words ', 21quinquiesdecies' shall be inserted between the words «, 21quater» and the words "or 21noviesdecies".
CHAPTER 9. -Amendments of the law of 8 July 1964 on medical aid urgent s. 71. in the law of 8 July 1964 on urgent medical aid, it is inserted a numbered article 10quater as follows: «art.» 10quater. medical directors referred to in articles 2, paragraph 1, 3 °, and 10 of the royal decree of October 17, 2011 on the 112 centres and 112 Agency and Deputy medical directors referred to in articles 2, paragraph 1, 4 °, and 11 of the same royal decree are entitled to access the necessary data relating to the dispatch of emergency medical assistance, from the call to the emergency services the information captured to organize dispatching and the information recorded at the level of ambulance attending the emergency medical services of the hospital functions participating in the urgent medical assistance, to enable them to consult these data in the event of complaints and to increase the quality of the urgent appeals-related medical treatment.
The King fixed, on a joint proposal from the Minister of the Interior and the Minister having health in its attributions and after receiving the opinion of the Committee on the protection of privacy, the terms of access to the data referred to in paragraph 1. ».
CHAPTER 10. -Amendment of the law of 4 June 2007 amending the legislation to promote the mobility of patients s.
72. article 5, paragraph 1, of the Act of 4 July 2007 amending the legislation to promote the mobility of patients is complemented by 9 °, as follows: «9 ° a representative of Federal Ministers in charge of public health and Social Affairs their.
CHAPTER 11. -Amendments to order royal No. 143 of 30 December 1982 laying down conditions which laboratories must respond to the intervention of insurance compulsory health care for clinical biology benefits article 73. in article 3, § 1, paragraph 1, of the royal decree No. 143 of 30 December 1982 laying down the conditions with which laboratories must comply to the intervention of the insurance mandatory health care for the benefit of clinical biology, as amended by the law of May 24, 2005, the following changes are made: has) the 3rd is replaced by the following (: "3 ° or by a corporation that operates a hospital where the laboratory work for the hospital, as doctors, pharmacists and the licensees in chemistry who are entitled to benefits of clinical biology, fall from the scope of title IV of the Act relating to hospitals and other care facilities, coordinated on July 10, 2008;" b) inserted 3 ° as follows 1 : '3 ° 1 or by an association of hospital referred in the Act relating to hospitals and care facilities, coordinated on July 10, 2008 and its orders of execution when the laboratory work for hospitals that participate in the association and as physicians, pharmacists and licensees in chemistry who are authorized to provide clinical biology machinery in respect of the scope of title IV of the Act to hospitals and other institutions care, coordinated on July 10, 2008; » CHAPTER 12. -Federal Agency for medicines and the products of Health Section 1.
-Amendments to the law of 25 March 1964 on medicines sub-section 1.
-Advanced therapy medicinal products article 74. in article 1, § 1, of the law of 25 March 1964 on medicines, replaced by the law of 1 May 2006, the 4/1) is inserted, worded as follows: "4/1)"advanced therapy medicinal product": a product as defined in article 2 of Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004; ».
S. 75. the article 6quater, § 3, 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 ° in the 1st paragraph is inserted the 6/1) as follows: ' 6/1) advanced therapy medicinal products prepared an ad hoc basis according to specific quality standards, and used on the Belgian territory. , in a hospital under the exclusive professional responsibility of a medical doctor, to perform a medical prescription for a product specially designed for a patient determined; »;
2 ° in paragraph 2, the word "6/1)", is inserted between the words '6 °)', and '7 °) '.
S. 76. article 75 comes into force at a date to be determined by the King.
Sub-section 2. -Demarcation of the definition of Medicine article 77A article 1, § 2, paragraph 5, of the law of 25 March 1964 on medicines, replaced by the law of 1 May 2006, the following changes are made:
1 ° in the first sentence, the words "or his delegate" shall be inserted between the words "the Minister" and "may decide ';
2 ° in the second sentence, the words "or his delegate" shall be inserted between the words "the Minister" and "means".
3 ° in the third sentence, the words "or his delegate" shall be inserted between the words "the Minister" and "fixed."
Sub-section 3. -Medicinal products for veterinary use s. 78A article 6quater, § 2, 3 °), of the same Act, inserted by the law of 1 May 2006, the following changes are made: 1 ° in the first sentence, the word "temporarily" is inserted between the words 'allow' and 'development ';
2 ° the first sentence is supplemented by the words: "or, failing this, in a third State which applies the international guidelines for the quality of such medicines as defined by the King.".
Subsection 4. -Promotion and advertising art.
79. in article 10, § 3, paragraph 1, of the Act, inserted by the law of December 16, 2004, «with at least one night» shall be replaced by the words "taking place on several days consecutive calendar, including hospitality related, holders of authorisation for placing on the market or drug registration,".
Subsection 5. -Manufacturing and distribution wholesale art. 80. article 12bis, § 1, paragraph 10, of the same Act, inserted by the Act of May 1, 2006, is supplemented by the following sentence: "The King may set the content of the authority.".
S. 81. article 12ter, paragraph 5, of the Act, inserted by the law of 1 May 2006, is supplemented by the following sentence: "The King may set the content of the authority.".
Sub-section 6. -Corrigenda s.
82. in article 12A, § 1, paragraph 10, of the same Act, inserted by the Act of May 1, 2006, the words "as well as medicines and forms" are replaced by the words "as well as for medicines and forms.
In article 12ter, paragraph 5 of the same Act, inserted by the Act of May 1, 2006, the words "as well as medicines and forms" are replaced by the words "as well as for medicines and forms.
Section 2. -Amendments to the law of 24 February 1921 regarding traffic in poisonous, soporific, narcotic, psychotropic, disinfectant or antiseptic substances and substances that can be used in the illicit manufacture of narcotic and psychotropic substances article 83. in article 1, paragraphs 1 to 3, of the Act of 24 February 1921 regarding traffic in poisonous, soporific, narcotic, psychotropic, disinfectant or antiseptic substances and substances that can be used in the illicit manufacture of narcotic and psychotropic substances, replaced by the law of 3 May 2003, the words ', by Decree deliberated in the Council of Ministers ", are each repealed.
84. in article 1bis of the Act, inserted by the Act of 22 July 1974 and amended by the law of 3 May 2003, the words ', by Decree deliberated in the Council of Ministers, "are repealed.
Section 3. -Amendments of Act of 5 July 1994 on blood and derivatives of human origin blood art. 85. article 1, § 1, of Act of 5 July 1994 on blood and human blood derivatives, as amended by the law of December 19, 2008, is supplemented by a paragraph worded as follows: ' by way of derogation from paragraph 1, this Act does not apply to blood and blood of human origin derivatives which are used for scientific research without human application. ''
S. 86. article 9 of the Act, as amended by the royal decree of 1 February 2005 and by the law of July 19, 2011, is replaced by the following: «art.» 9. no levy may be performed in patients less than 18 years. In the event of extreme medical necessity, the levy may be carried out also in patients under 18, with written permission signed by parents or legal representative and on the authorisation by the blood establishment physician. However, if a minor is able to express consent or notice, the physician is required to collect.
Withdrawals can only be made from the 71st anniversary that subject to the conditions laid down by the King, unless they are performed for the purpose of transfusion autologous programmed.
The authorization of new donors, over the age of 60 years, depends on the opinion of the doctor of the blood establishment. New donors who have reached their 66th birthday are not allowed.
Without prejudice to paragraph 3, the permission of donors from their 65th birthday is subject to the discretion of the blood establishment physician. The permission of donors from their 66th birthday is given only if it comes from a donor whose last collection goes back to more than three years.
A sample by Apheresis to double erythrocyte sampling, can only be carried out on persons of less than 66 years. » Art. 87. in article 17, § 2, paragraph 2 of the Act be replaced by the royal decree of 1 February 2005, "provided that the annual amount deducted does not exceed 32 ml per kilogram of body weight" shall be replaced by the words "insofar as at least two months elapse between two blood samples".
Section 4. -Changes of the experiments on the human person subsection 1st law of May 7, 2004. -Provisions amending art. 88. in section 2 of the experiments on the human act of May 7, 2004, as last amended by the Act of July 24, 2008, the following changes are made: 1 ° 4 ° is replaced by the following: "4 °"Ethics Committee": independent body, composed of professionals of health and members not belonging to the medical world. to preserve the rights, safety and well-being of the trial participants and which reassures the public in this regard, including by formulating an opinion on the Protocol of testing, the suitability of the investigators and the adequacy of facilities, as well as on the methods and documents to be used to inform the trial participants to obtain their informed consent.
For the purposes of this Act, an Ethics Committee is:-either an "ethics with full Accreditation Committee": an Ethics Committee approved under article 11/2 the opinion referred to in article 10;
-either an "ethics with partial approval Committee": an Ethics Committee agreed to formulate a judgment on the institution to which the Committee is attached in what concerns the competence of the investigator and his collaborators, the quality of the facilities and the adequacy and completeness of the information written to provide as well as the procedure to follow to obtain consent and the justification for the research on subjects incapable of giving their consent or whose consent cannot be obtained because of the urgency for participation in an experiment, as referred to in article 11, § 4, 4 °, 6 ° and 7 °. »;
2 ° in 15 °, the words "paragraph 2 of the law on hospitals coordinated August 7, 1987, is a hospital referred to in article 7 (2), g), 1 ° of the royal decree of 25 April 2002 concerning the fixing and the liquidation of the budget of the financial means of the hospitals ' are replaced by the words 'of the Act of July 10, 2008 to hospitals and other care facilities";
3 ° in 15 °, the words "of the same order" shall be replaced by the words 'of the royal decree of 25 April 2002 concerning the fixing and the liquidation of the budget of the financial means of the hospitals'.
S. 89. in article 3, § 3, paragraph 1, of the Act, inserted by the law of December 19, 2008, the words "which operates no hospital," shall be inserted between the words "of a public interest organization" and the words "or of a body that has been created within it.".
S. 90. in article 4, paragraph 2, of the Act, the words "after notice of the Advisory Bioethics Committee" are repealed.
91. in article 5, 6 °, of the same law, «with full accreditation» shall be inserted between the words 'an Ethics Committee' and the word 'and '.
S. 92. at article 7, 6 ° of the Act, the following amendments are made: 1 ° "with full accreditation" is inserted between the words "Ethics Committee" and the words "whose members";
2 ° "with full accreditation" is inserted between the words "Ethics Committee" and the words "which consulted '.
93. in article 8, 5 ° of the Act, "with full accreditation" shall be inserted between the words "Ethics Committee" and the words "including a member."
S. 94. in article 9, 4 ° of the Act, "with full accreditation" shall be inserted between the words "Ethics Committee" and the words "including a member."
S. 95. in article 10, paragraph 1, of the Act, "with full accreditation' shall be inserted between the words"Ethics Committee"and the word"according ".
S. 96 A article 11 of the same Act, as amended by the Act of 27 December 2004, the following changes are made: 1 ° 1st paragraph is replaced by the following: "§ 1.» The investigator who wishes to organize an experiment in Belgium introduces its application with an Ethics Committee with full accreditation in accordance with article 11/2. »;
2 ° to § 2, paragraph 1, the following changes are made: a) the words «with full accreditation» are inserted between the words "by the Ethics Committee" and the words "which satisfied";
(b) the words "with full accreditation' shall be inserted between the
words "Ethics Committee" and the words "which satisfied";
(c) the words «with full accreditation» shall be inserted between the words "by an Ethics Committee" and the words "designated by the sponsor."
d) the words "which satisfies the condition laid down in article 2, 4 ° paragraph 2, ' and the words ' which satisfies the condition laid down in article 2, 4 °, second indent, paragraph 2," are repealed;
(e) the words 'is referred to in article 2, 4 °, second indent' are replaced by the words "is attached to a Faculty of medicine or a scientific society of general medicine.
3 ° in paragraph 2, paragraph 2 is replaced by the following: "in this case, ethics with full accreditation board deliver its opinion within a period of 20 days to the Ethics Committee with partial approval relating to the site or structure where experimentation is carried out after to be previously ascertained it to find out if the site in question is likely to meet the conditions laid down in § 4 4 °, 6 ° and 7 °. »;
4 ° paragraph 2 is supplemented by a paragraph worded as follows: "after the notification referred to in the preceding paragraph, the Ethics Committee with partial approval relating to the site or structure where experimentation is carried out has 5 days to send a response to the Ethics Committee that issued the notice. The Committee accepts or refuses, without that it could submit a proposal to amend except in § 4, 7 °. If the response fails within the period the Committee issuing the notice, site or structure can receive the test. »;
5 ° to paragraph 3, the following changes are made: a) in the paragraph 1, the words «with full accreditation» are inserted between the words "Ethics Committee" and the words "regardless";
(b) in paragraph 2, the words «with full accreditation» are inserted between words 'Ethics Committee' and the words 'of this hospital. "
(c) in paragraph 3, 'with full accreditation' shall be inserted between the words "ethics committees" and the words "related to these hospitals."
(d) in paragraph 4, the word 'registered' is inserted between the words "by the Committee' and the words ' hospital '.
(e) in paragraph 6, "with full accreditation" shall be inserted between the words 'an Ethics Committee' and ' referred to in article 2 '.
(f) in the same paragraph, the words ' referred to in article 2, 4 °, paragraph 1, second indent ' are replaced by the words "attached to a Faculty of medicine or a scientific society of general medicine.
6 ° paragraph 4 is supplemented by two paragraphs worded as follows: "notice is motivated.
The King may lay down rules concerning the reasons referred to in the preceding paragraph. »;
7 ° paragraph 7 is replaced by the following: "§ § 7 7» In the case of multi-centre experimentation, the request for an opinion is introduced concurrently with the Ethics Committee empowered to deliver the unique opinion and other ethics committees that are attached to the sites on which would take place the experiment if it took place.
The Ethics Committee empowered to deliver the unique opinion delivers its opinion within 20 days to other ethics committees after previously questioned them about the ability of the site concerned to meet the requirements of § 4, 4 °, 6 ° and 7 °.
After the communication referred to in the preceding paragraph, the ethics committees that do not render the single opinion have 5 days to transmit a response to the Ethics Committee empowered to deliver the unique opinion.
They accept or they refuse, without that it is possible to propose amendments, with the exception of § 4, 7 °. If the response of the Committee fails to the Ethics Committee empowered to deliver the unique notice in a timely manner, the site to which the Ethics Committee is attached can accommodate the test.
8 ° in paragraph 10, paragraph 1, the words "and invented somatic" are replaced by the words "somatic cellulotherapy and tissue engineered products.
S. 97. in Chapter VIII of the Act, it is inserted an article 11/1: «art.» 11/1. § 1. An Ethics Committee of a hospital as referred to in article 70 of the Act of 10 July 2008 to hospitals and other care facilities, is approved of right as Ethics Committee with partial approval for the purposes of this Act.
§ 2. Without prejudice to paragraph 1, an Ethics Committee may be approved as Committee on ethics with partial approval on condition that it is:-attached to an institution: to a Faculty of medicine, either attached to "Scientific society of General Medicine (SSMG)" or the "Wetenschappelijke Vereniging voor Huisartsgeneeskunde (WVVH)."
-compound for a minimum of 8 members and a maximum of 15 members representing both sexes.
Only an Ethics Committee may be approved by institution provided that it meets the other provisions referred to in this paragraph.
Application for approval shall be submitted by the legal person which depends on the Ethics Committee, in a form which the model is determined by the Minister.
The application referred to in the preceding paragraph is admissible: 1 ° if the form is duly completed.
2 ° if it includes in the annex names, the kind and the quality of the members;
3 ° If the application is done by registered letter with acknowledgement of receipt or carrier with acknowledgment of receipt.
The application can be done electronically in the manner laid down by the Federal Agency for medicines and health products. The form in electronic form shall bear an advanced electronic signature realized on the basis of a certificate attesting to the identity of the corporate applicant and designed via a secure electronic signature creation, in accordance with the applicable law.
The King may lay down rules of composition and operation of the Committee of ethics with partial approval.
The members of the Committee are at the time of their designation to the Minister a statement of their direct or indirect links with the promoters of research excluding proponents of non-commercial experimentation. May validly participate in deliberation, people who are not independent of the sponsor of the research reviewed in the light of the above-mentioned statement.
§ 4. For the exercise of its tasks referred to in this Act, with regard to the interventional clinical trials, Ethics Committee communicates through interactive and secure web site for that purpose from the Federal Agency for medicines and health products.
The King may set terms and conditions for the application of this paragraph.
The composition of the Committee and the declarations referred to in paragraph 3 are published and updated on the initiative of members whenever a change occurs on these links or that new links are forged, through the web site referred to in paragraph 4. ».
S. 98. in Chapter VIII of the Act, it is inserted an article 11/2, as follows: «art.» 11/2. § 1.
"" Can lay claim to an approval Committee of ethics with full accreditation, ethics with partial approval Committee: 1 ° which has a quality system for the application of the principles and detailed guidelines among others for good clinical practice as set out in the guidelines at the international level by the "International Conference on harmonization", "ICH E6: Good Clinical Practice. ", Consolidated Guideline CPMP/ICH/135/95";
2 ° which has a registration and management system for conflict of interest of members;
3 ° the skills and expertise of its members are sufficient for the examination of the submitted experiments.
The King may set the standards with which the systems referred to in paragraph 1, 1 ° and 2 °, must comply.
The King may, after consultation with the Advisory Bioethics Committee, lay down the conditions and detailed rules concerning the composition, and the skills and expertise of its members, for the purposes of paragraph 1, 3 °.
§ 2. The request for approval or extension of approval shall be submitted by the legal person which depends on the Ethics Committee, in a form which the model is determined by the Minister.
The request referred to in paragraph 1 is admissible: 1 ° if the form is duly completed.
2 ° if it includes in the annex a description of the system of quality and the system for recording and management for conflict of interest;
3 ° If, in the case of a new application for approval, it includes in the annex names, the kind and the quality of the members;
4 ° if it brings proof of insurance civil liability for members;
5 ° If the introduction of the application must be made by registered letter with accused of receipt or by carrier with acknowledgment, before January 1 of the year for which the authorization or extension is sought.
The application may be made in electronic form according to the procedures laid down by the Federal Agency for medicines and health products. The form in electronic form shall bear an advanced electronic signature realized on the basis of a certificate attesting to the identity of the corporate applicant and designed via a secure electronic signature creation, in accordance with the applicable law.
§ 3. Accreditation is granted by the Minister for a renewable period of four years.
Approvals referred to in paragraph 1 shall enter into force on 1 April following the decision referred to in paragraph 1. Subject
the condition of admissibility referred to in § 2, paragraph 2, 5 °, absence of a decision before that date, the approval is regarded as being tacitly granted.
The Minister refused 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 multi-centre experimentation as the Committee competent for the issuance of the unique notice;
2 ° either has not in the least tested averaged 40 new protocols of multi-centre experimentation in the quality of Committee competent for issuing the single opinion or nonunique notice.
§ 4. The Minister refuses approval, shall suspend approval or withdraws, if the Ethics Committee fails to comply with its obligations imposed by the Act or its implementing orders.
§ 5. The Ethics Committee is represented at each consultation organized by the Federal Agency for drugs and health products regarding the Act and its implementation orders. ».
S. 99 ÷ section 14 of the Act, as amended by the Act of 27 December 2004, the following changes are made: 1 ° in paragraph 2, the words 'and clinical"are inserted between the words 'preclinical' and 'of the investigational drug."
2 ° article is supplemented by a paragraph worded as follows: «the King determines the modalities and procedures for the review of clinical and preclinical data referred to in paragraph (2) and for cooperation and the exchange of information between the Federal Agency for medicines and health products and the Ethics Committee. ''
S. 100. in article 30, § 4, of the Act, the words "after notice of the Advisory Bioethics Committee" are repealed.
S. 101. under article 31 of the Act, subsection 4 is repealed.
Sub-section 2. -Disposition transitional art.
102. amenities approving to the notice in a monocentric experiment or unique in a multi-centre experiment, granted before the date of entry into force of this Act shall remain valid until April 1, 2014.
Section 5. -Amendments to the law of 20 July 2006 relating to the creation and operation of the Federal Agency for drugs and health products section 103. at article 4, § 1, paragraph 3, 6 °, (j), by Act of 20 July 2006 on the creation and operation of the Federal Agency for medicines and health products, inserted by the law of July 24, 2008, the following changes are made: 1 ° between the digit '6 ' and the number '15', the words 'paragraph 2', are repealed;
2 ° the figures '15', '16' and "44," are repealed.
Section 6. -Material body human sub-section 1. -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. 104. at article 2 of the law of 19 December 2008 on obtaining and use of human body material intended for human or for purposes of scientific research, medical applications, amended by law of December 23, 2009 and July 3, 2012, the following changes are made: 1 ° in the 23 °, the words "This implies also the ability" are replaced by the words "where the material body human is intended for an application. «medical human, this also implies the capacity.»
2 ° in 24 °, the words "with human body material intended for human medical application" are inserted between the words «18 °» and «.» This ";
3 ° in the 25th, the words "intended for human medical application" shall be inserted between the words "human body material" and ", in collaboration."
4 ° 26 ° in the words "with the exception of control," are repealed;
5 ° 27 ° is replaced by the following: ' 27 ° "BioBank": the structure which, for purposes of scientific research, with the exception of research with human medical applications, gets, appropriate processes, stores and puts at the disposal of human body materials, as well as, where appropriate, the human body material and the donor related data;
6 ° it is inserted the 28 ° 1 worded as follows: "28 ° 1 'human body material within the BioBank Manager': the person in the BioBank which has the powers and responsibilities as referred by and fixed under this Act;
S. (105a article 3 of the same Act, as amended by the law of December 23, 2009, the following amendments are made: 1 ° paragraph 3, b), is supplemented by the words '' except where obtaining, storage and availability are made by a BioBank.
2 ° paragraph 3, paragraph 2, is supplemented by the words 'unless they are intended for scientific research ";
3 ° paragraph 4 is supplemented by two paragraphs worded as follows: "BioBank who obtains, stores and makes available to the gametes, embryos or fetuses is operated exclusively by the operator of an accredited laboratory as referred to in article 3, 3 °, of the law of 11 May 2003 relating to research on embryos in vitro.".
Article 9 also applies to the gonads and gonad fragments if they are used directly or indirectly to create embryos or present gametes are intended to be used as what. ».
S. 106 A article 4 of the same Act, as amended by the law of December 23, 2009, the following amendments are made: 1 ° in the paragraph 1, paragraph 1, the word 'and' shall be inserted between the words 'doctor' and 'in '.
2 ° a 1/1 paragraph worded as follows is added: "§ 1/1."
By way of derogation from paragraph 1, the levy of body human material in living donor which is exclusively aimed at obtaining by a notified BioBank may take place outside of a hospital referred to in paragraph 1.
The King may lay down the conditions more precise under which the levy provided for in this section is performed. »;
3 °, paragraph 2 is replaced by the following: 'without prejudice to article 8, § 2, human body material collected is sent to a Bank of human body material which meets the requirements referred to in this Act and which has been approved in accordance with this Act, or, if the human body material is exclusively for research without human application a BioBank notified which complies with the provisions referred to in this Act. ».
S. "" 107. in article 7, § 1, paragraph 3, of the Act, the words "of human body materials" are inserted between the words "Bank" and ", of each intermediate structure.
108 A section 8 of the Act, the following amendments are made: 1 ° 1st paragraph, 1st indent, 5 ° is supplemented by the words ', or outside of a notified BioBank ";
2 ° paragraph 1, paragraph 1, 6 °, is supplemented by the words ', is a BioBank notified. ";
3 ° in the paragraph 1, 1st paragraph, 7 is replaced by the following: ' 7 ° with the exception of products manufactured, referred to the 6th, and without prejudice to paragraph 2, the export of human body material by any other person, either a Bank of human body materials approved or an intermediate structure of human body material which has obtained the consent of the Manager of the body human material of the licensed bank which gave the body material. , either a notified BioBank, and import by anyone other than a Bank of human body materials approved or a BioBank notified; »;
4 ° 1st paragraph, paragraph 1, is completed by 9 °, as follows: "9 ° without prejudice to article 6, § 3, the payment or the perception of a material consideration for the transfer, licensing or receipt of human body material which has not undergone any form of treatment within a Bank of human, an intermediate structure or a BioBank body material in order to make the material human body suitable for human use or for scientific research. »;
5 ° in paragraph 2, paragraph 1, the words ", except the control," are repealed;
6 ° in the paragraph 2, subparagraph 2 is repealed;
7 ° paragraph 2 is supplemented by a paragraph worded as follows: «collected human body material intended for human scientific research without medical application is transferred to a notified BioBank»;
8 ° a 2/1 paragraph worded as follows is added: "§ 2/1. Human body material that is made available to research scientific or used for purposes of scientific research, excluding research with human medical applications comes from a BioBank.
Human body material which is obtained by a BioBank can no longer be made available or used for human medical applications, nor for any other human application. ».
S. 109. in article 10, § 5, paragraph 6, of the Act, the words "or, where appropriate, human body material within the BioBank Manager" are inserted between the words 'human body material' and ' what it '.
110. article 11 of the Act is replaced by the following: «art.» 11. where, during an operation carried out with human body material traceable as referred to in articles 14 and 22, § 5, or when the use of human body material traceable as referred to in articles 14 and 22, § 5, analyses generate any meaningful information on the State of health of the donor, it is entitled to this information.
For the purposes of paragraph 1, article 7, §§
2, 3 and 4, of the Act of 22 August 2002 on the rights of the patient shall apply mutatis mutandis in respect of the donor.
Physicians who have knowledge of the information referred to in paragraph 1 during operation or use, managers of human body material, the managers of the human within the BioBank material, as well as the chief physician of the hospital in which the sampling took place, are each responsible, in the context of their function of their skills, from the application of paragraphs 1 and 2.
In the case referred to in article 4, § 1, paragraph 3, the application of paragraph 3 is made also by the doctor concerned of the establishment referred to in the law of 5 July 1994 on blood and human blood derivatives.
In the case of a levy in a living person outside a hospital as referred to in article 4, § 1/1, paragraph 1, the application of paragraph 3 is made also by the physician in charge of collection which becomes aware of the information referred to in paragraph 1. » Art. 111. in article 12 of the same Act, amended by the law of December 23, 2009, the following changes are made: 1 ° a paragraph worded as follows is inserted before paragraph 1: "the death of the donor is found by a physician who is not the doctor who will perform the levy or under the responsibility of which will be taken, nor the Manager of human body material. , or the Manager of the human body material in the BioBank. »;
2 ° in paragraph 1, which becomes paragraph 2, the word '11' is repealed;
3 ° in paragraph 1, which becomes paragraph 2, the word '14' is replaced by '4bis.
S. 112. article 13, paragraph 1, of the Act, is complemented by 3 ° as follows: «3 ° or, in the case of application of article 4, § 1/1, paragraph 1, a physician who is appointed by the notified BioBank for which collected human body material is intended and provided that intended sampling takes place pursuant to an agreement in writing between the doctor and the referred BioBank.»
» Art. 113 A section 15 of the Act, the following amendments are made: 1 ° in the paragraph 1, paragraph 1, the words 'or human body material within the BioBank Manager' shall be inserted between the words "Bank of human body material" and "ensure";
2 ° in paragraph 2, the words "human body material" are each time inserted between the words "Bank" and "an intermediate structure", between the words 'Bank' and 'or an intermediate structure' and between the words "Bank" and "concerned".
S. 114. at article 16 of the Act, the following amendments are made: 1 ° in the paragraph 1, the words 'of human body materials' shall be inserted between the words 'Bank' and ', intermediate structure. "
2 ° in paragraph 2, the words "human body material" are inserted between the words 'Bank' and ', the intermediate structure '.
115 A article 17 of the Act, the following amendments are made: 1 ° in the paragraph 1, paragraph 1, the words "human body material" are inserted between the words 'banks' and ', intermediate structures' and the words 'Bank' and ', their intermediate structure ";
2 ° a 1/1 paragraph worded as follows is added: "§ 1/1." Human body material within the BioBank Manager fixed a procedure on the destination of the human body material if the BioBank ceases temporarily or permanently its activities.
This procedure provides, where appropriate, the conditions and rules under which an another BioBank that ceased operations resumed human body material stored by the latter. »;
3 ° in paragraph 2, the words "or § 1/1» are inserted between the words" § 1 "and", must ";
4 ° in paragraph 3, the words 'and 2' shall be replaced by the words ", 1/1 and 2.
S. 116 A section 20 of the Act, as amended by the Act of December 23, 2009, the following amendments are made: 1 ° in the paragraph 1, paragraph 1, the words ', or, where the human body material has already been stored or made available by a BioBank, the human body material within this BioBank Manager» shall be inserted between the words «human body material Manager» and «and»;
2 ° in paragraph 2, paragraph 4, the words "human body material or BioBank" shall be inserted between "the Bank" and "concerned".
S. 117A article 21 of the same Act, as amended by the law of December 23, 2009, the following amendments are made: 1 ° in the paragraph 1, the words 'and 11ter» are inserted between the words '2, 4 °', and ' the law ';
3 ° in paragraph 5 becomes paragraph 4, the words "or equipment manager notified body human in the BioBank" are inserted between the words "human body material" and "ensure".
S. 118. the title of Chapter VI of the Act is replaced by the following: ' chapter VI '. -Special provisions relating to biobanks.
S. 119 in section 22 of the Act, the following amendments are made: 1 ° 1st paragraph is replaced by the following: "§ 1.» A BioBank can only be exploited if it is notified to the Federal Agency for drugs and health products.
The King sets, by Decree deliberated in the Council of Ministers, the terms and conditions to meet the notification referred to in paragraph 1, rules for the amendment and stop activities as well as the measures that can be taken to ensure the implementation and control of this Act.
The objectives and activities of each BioBank subject to a favourable opinion of an Ethics Committee as referred to in article 11, § 3, paragraph 2, of the experiments on the human act of May 7, 2004.
Favourable opinion referred to in paragraph 3 is worth as a favourable opinion referred to in article 8, § 1, paragraph 1, 2 ° as the goal for scientific research survey of the objectives, purposes and activities of the concerned BioBank to which relates the notice referred to in paragraph 4.
Favourable opinion referred to in paragraph 3 as a favourable opinion referred to in article 21, paragraphs 1 and 3, 1 °, provided that the referred secondary use for scientific research is goals, purposes and activities of the concerned BioBank to which relates the notice referred to in paragraph 4.
Favourable opinion may be revised or withdrawn. Any revision or any withdrawal is motivated and communicated by the Ethics Committee to the Federal Agency for drugs and health products.
The King lays down the conditions which must be met so that favourable opinion referred to in paragraph 3 may be amended or withdrawn, as well as the terms and conditions under which the BioBank concerned must, as a result of this change, or withdrawal, stop completely or partially its activities or may pursue them temporarily.
The King may attach conditions and rules according to which the BioBank reports regularly on its objectives and activities to the Ethics Committee that delivered the favourable opinion. »;
2 ° in paragraph 2, two paragraphs worded as follows shall be inserted between paragraphs 2 and 3: 'the availability of human body material by a notified BioBank is the subject of an agreement between the Manager of the human body material in BioBank and the person or institution to which the human body material is made available.
The agreement referred to in paragraph 3 rule inter alia the possible treatment of the personal data of the donor by the person or institution to which the body material is made available, in accordance with the provisions of the law of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data. »;
3 ° in paragraph 2, paragraph 3, which becomes paragraph (5), is replaced by the following: 'The King fixed the modalities for the application of this paragraph.';
4 °, paragraph 3 is replaced by the following: "§ § 3 3» If the BioBank gets, stores or puts at the disposal of the human body material traceable, Manager of human corporeal material within the BioBank is a doctor.
If BioBank gets, stores, or makes available exclusively to human body material non-traceable, Manager of the human body material within the BioBank is a physician or a pharmacist.
Human body material within the BioBank Manager shall ensure that, for each unit of human body materials, articles 10, 20 and 21 of the Act are met.
In the case of appointment of a new Manager for the human body material within the BioBank, this designation shall be forwarded immediately to the Federal Agency for drugs and health products specifying the date of entry on the basis of the new Manager. »;
5 ° article is supplemented by paragraphs 4 to 9 worded as follows: ' ' § § 4 4 In what concerns the human body material of living donors and obtained by the BioBank, without prejudice to the provisions of the law of 7 May 2004 relating to experiments on the human person, the fact that concerned human body material is traceable or not depends on the consent of the donor or the person who, pursuant to this Act is entitled to give consent for the collection.
In the case of residual human body material or human body material which is taken from a deceased person, the option referred to in paragraph 1
lies in the head of the next person who provides human BioBank notified body material: 1 ° is the Manager of the body human material of the establishment concerned as referred to in the royal decree of 28 September 2009 laying down general conditions which banks of human body materials, intermediate structures and production facilities must satisfy to be approved;
2 ° is a doctor in the concerned laboratory for clinical biology.
The King may lay down more specific conditions which must satisfy this laboratory;
3 ° is the Chief doctor of the hospital concerned;
4 ° be a doctor in the institution as referred to in the Act of 5 July 1994 to blood and human blood derivatives.
§ 5. Where, pursuant to paragraph 4, it is opted for traceability, the human body material within the BioBank manager ensures anytime traceability with regard to human body material that is stored in the BioBank. Human body material within the BioBank Manager provides the encoding body human material to obtain it, except if this encoding has already taken place previously, either by the Manager of a Bank of human body material, either in application of the experiments on the human act of May 7, 2004.
This encoding allows to find anytime, so certain and unequivocal, the identity of the donor but also to avoid that this identity can be known by third foreigners in concerned BioBank.
The King may establish the methods of this encoding.
Where it is opted for traceability and that human body material is entrusted to its use, to a third party who is not a BioBank notified, the human body material within the BioBank manager ensures that traceability is continued and that the Act and its implementation orders are respected.
Where it is opted for traceability and the human body material is transferred between Biobanks, different human body material within the BioBank managers ensure continuity of traceability.
All persons conducting samples or operations with human body material traceable to or from a BioBank, are required to communicate to the human body material within the BioBank Manager all information necessary for the guarantee of the traceability.
All persons who are responsible for the use of human body material from a BioBank are required to take all necessary measures and to communicate all the necessary information in order to ensure traceability.
6. Where, pursuant to paragraph 4, it is opted for the non-traceability, this is done before the transfer of the human body material in notified BioBank.
§ 7. Human body material within the BioBank Manager can at any time throw the traceability of human body material it gets, stores, or makes available, if the donor or the person authorized to give consent for the removal has previously given consent therefor.
Where it is found that there is appropriate to apply article 11, traceability can be lifted once the procedure referred to in article 11 is fully respected.
§ 8. The personal data which are kept in the BioBank are preserved up fifty years after graduation of the human body material.
§ 9. The King determines, after the opinion of the Committee on the protection of privacy, the rules relating to the application of paragraphs 3 to 7 in order to ensure the traceability and identification of the donor in accordance with the provisions of the law of 8 December 1992 relative to the protection of privacy with regard to the processing of personal data.
S. 120A section 24, § 1, of the Act, the following changes are made: 1 ° in the paragraph 1, the words "§ 1/1," shall be inserted between the words "1 and 3," and '6 '.
2 ° in paragraph 2, the words ' 22, § 1, ' are replaced by '22 '.
3 ° in paragraph 2, the words, '8, § 2, paragraphs 1 and 2', shall be inserted between the words "paragraph 3", and "10";
4 ° in paragraph 3, the words ' and 9 °, 8, §§ 2, paragraph 4, and 2/1 ' shall be inserted between the words '1 °' and ', and 10.
S. 121. in the Act, it is inserted an article 45/1 as follows: "provisions modified by the law of the... with various provisions (I) health, which concern sections 22, §§ 3 to 8 apply only to human body material that is collected from the date of entry into force of this Act.".
S. 122. in article 46 of the Act, as amended by the law of December 23, 2009, the words ", with the exception of article 22, which comes into force on a date to be fixed by the King" are repealed.
Sub-section 2. -Amendment of the law of December 23, 2009, relating to the provisions on public health article 123. article 34 of the law of December 23, 2009, relating to the provisions on public health is hereby repealed.
Sub-section 3. -Entry into force art. 124. This section comes into force on a date to be determined by the King, by royal decree deliberated in the Council of Ministers.
CHAPTER 13. -Amendments of Act of 29 April 1999 on unconventional practices in the areas of medical art, pharmaceutical art, physiotherapy, nursing and paramedical professions s.
125. article 4, paragraph 2, of the Act of 29 April 1999 on unconventional practices in the areas of medical art, the pharmaceutical art, physiotherapy, nursing and paramedical professions is repealed.
CHAPTER 14. -Modification of the programme law (I) of 27 December 2006 article 126. article 245 of the programme law (I) of 27 December 2006, as amended by the laws of the December 23, 2009, July 4, 2011 and March 29, 2012, is replaced by the following: 12).
«Art.» 245 § 1. Grants from the budget for the administrative expenses of the national Institute for sickness and invalidity insurance referred to in article 12, 6 °, of the law on compulsory insurance health care and benefits, co-ordinated on 14 July 1994, are granted to the two associations of patients following: 1 ° ASBL "League of users health."
2 ° ASBL "Vlaams Patientenplatform".
The amount of the above grants charged to the budget of expenses of administration of the Institute, amounted annually to 138.412,35 euros respectively for each of the two associations mentioned in the preceding paragraph, and is fully supported by the health care sector.
§ 2. Grants charged to the budget of the cost of administration of the Institute are awarded annually to the association of patients ASBL "Rare Diseases United Belgium" (Belgian Alliance for rare diseases). These grants amounted annually to 40,000 euros and are fully supported by the health care sector.
3. The payment of the subsidy referred to in paragraphs 1 and 2 is done by granting in April to each recipient association a deposit whose amount is fixed by the King. The payment of the balance takes place after receipt of the documents referred to in paragraph 5, subject to paragraph 6.
§ 4. Grants are intended for personnel and operating costs that recipient associations has committed to the development and support for initiatives in relation to chronic diseases and rare diseases, which fall under federal jurisdiction.
§ 5. The award of grants shall be subject to compliance with the following obligations:-communication from the statutes and statutory modifications of the beneficiary association, as filed at the commercial court;
-communication of the annual financial report and the annual report of activities, including the information collected from the representative associations of patients at the request of the Minister of Social Affairs or the Minister of public health, on expectations of these patients or on the perception or the impact of measures taken on behalf of these patients.
§ 6. If the amount of the expenditure actually incurred is lower than the amount of allocated payments referred to in paragraph 3, the Institute retrieves the difference between the amount of the instalments and the expenses incurred, unless otherwise decided by the general Council in the event of reasoned justification.
If the amount of the expenses incurred exceeds the amount of the payments referred to above but less than the total grants, the Institute pays only the difference between these costs and the advance payment, unless otherwise decided by the general Council in the event of reasoned justification.
§ 7. The King lays down the rules and conditions of suspension and recovery total or partial breach of the conditions laid down.
The King may assign a specified amount of subsidies to the performance of a particular task it determines.
§ 8. The amounts referred to in paragraphs 1, 2 and 3 fixed for 2013 are adapted to 1 January of each year on the basis of the evolution of the value of the index health, as referred to in article 1 of the royal decree of 8 December 1997 laying down the detailed implementing rules for the indexing of benefits in the insurance scheme compulsory health care , between 30 June of the last year and June 30 of the previous year. ».
127. article 126 is effective January 1, 2013.
CHAPTER 15. -Changes in the programme act of 22 June 2012 s. 128 A article 128, paragraph 6, of the programme act of 22 June 2012 the following changes are made: 1 ° the words «31 May 2013» are replaced by the words 'July 31, 2013 '.
2 ° the words "30 June 2013" are replaced each time by '31 August 2013 '.
ALBERT by the King: the Minister of public health, Ms. L. ONKELINX sealed with the seal of the State: the Minister of Justice, Ms. A. TURTELBOOM _ Note records of the House of representatives: 53 - 2600 - 2012/2013 No. 1: Bill.
The Senate documents: 5 - 1995 - 2012/2013 N ° 1: project referred by the Senate.
No. 3: Report No. 4: Decision not to amend No. 5: text adopted annals of the Senate: March 7, 2013.