natgillin/translations-raw huggingface dataset:
V případech, kdy se žádost o nucenou licenci týká léčivého přípravku registrovaného v souladu s článkem 6 směrnice 2001/83/ES, se nepoužijí ustanovení čl.
Where the application for a compulsory licence concerns a medicinal product authorised in accordance with Article 6 of Directive 2001/83/EC, the provisions of Article 24(4) and (5) and of Article 14(4) and (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council
10 odst.
1. shall not apply.
1 Směrnice 2001/83/ES se nežádá, aby žadatel předložil výsledky předklinických zkoušek a klinických hodnocení, pokud může doložit, že předmětný přípravek je generickým referenčním léčivým přípravkem, který je nebo byl registrován podle článku 6 uvedené Směrnice nebo podle článku 3 nařízení (ES) č. 726/2004.
For the purpose of the application of this paragraph, and by way of derogation from Article 10(1) of Directive 2001/83/EC, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the product concerned is a generic of a reference medicinal product which is or has been authorised under Article 6 of that Directive or under Article 3 of Regulation (EC) No 726/2004.
V případech, kdy se žádost o nucenou licenci týká léčivého přípravku, může žadatel využít
Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of
a) vědeckého stanoviska podle článku 58 nařízení (ES) č. 726/2004 nebo
a) the scientific opinion procedure as provided for under Article 58 of Regulation (EC) No 726/2004, or
b) jakékoli obdobné postupy podle vnitrostátního práva jako vědecká stanoviska nebo vývozní certifikáty určené výhradně pro trhy mimo Společenství.
b) any similar procedures under national law , such as scientific opinions or export certificates, intended exclusively for markets outside the Community.
V případech, kdy se žádost o nucenou licenci týká léčivého přípravku a žadatel o nucenou licenci není držitelem registrace předmětného přípravku , která platí uvnitř Společenství, může využít vědeckého stanoviska podle článku 58 nařízení (ES) č. 726/2004 nebo obdobného postupu stanoveného podle vnitrostátního práva.
Where the application for a compulsory licence concerns a medicinal product and the applicant for the compulsory licence is not the holder of a marketing authorisation valid within the Community for the product concerned, he may avail himself of the scientific opinion procedure provided for under Article 58 of Regulation (EC) No 726/2004 or any similar procedure provided under national law .
The content of Article 16 is not entirely clear and needs to be reformulated.
The content of Article 16 is not entirely clear and needs to be reformulated .
Pokud žadatel o nucenou licenci provádí studie a soudní řízení nutné pro získání vědeckého posudku nebo jiný podobný postup stanovený vnitrostátními právními předpisy podle odstavce 2 tohoto článku, nepředstavuje to porušení práv vzniklých na základě patentu (nebo dodatkového ochranného osvědčení uděleného podle nařízení Rady (EHS) č. 1768/92 ze dne 18. června 1992 o zavedení dodatkových ochranných osvědčení pro léčivé přípravky 1 ).
Where the applicant for a compulsory license conducts studies and trials necessary to obtain a scientific opinion or other similar procedure provided for under national law as referred to in paragraph 2 of this Article, this shall not constitute an infringement of the rights conferred by a patent (or supplementary protection certificate granted pursuant to Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products 1 ).
1 Úř. věst.
1 OJ L 182, 2.7.1992, p.
Licensees will wish to be confident that the acts preparatory to applying for a scientific opinion will not leave them open to litigation by patent holders.
Licensees will wish to be confident that the acts preparatory to applying for a scientific opinion will not leave them open to litigation by patent holders .
Toto se nijak nedotýká článku 16.
Article 16 a
The insertion of a ‘Bolar provision’ means that the studies and trials necessary for a pharmaceutical product to be authorised and the consequent practical requirements are not to be seen as an infringement of the patent.
The insertion of a ‘ Bolar provision’ means that the studies and trials necessary for a pharmaceutical product to be authorised and the consequent practical requirements are not to be seen as an infringement of the patent.
The absence of such a provision results in work on developing new generic products being done outside Europe , in countries which have such a provision.
The absence of such a provision results in work on developing new generic products being done outside Europe , in countries which have such a provision.
The consequence is that jobs are lost within the Community.
The consequence is that jobs are lost within the Community.
Given that the development of generic products during the period covered by patent protection is allowed internationally in any case, the patent protection enjoyed by the right holder will not be abridged in practice.
Given that the development of generic products during the period covered by patent protection is allowed internationally in any case, the patent protection enjoyed by the right holder will not be abridged in practice.
The insertion is in line with EU Directive 2004/27/EC, which also envisages the introduction of a ‘Bolar provision’.
The insertion is in line with EU Directive 2004/27/EC, which also envisages the introduction of a ‘ Bolar provision’ .
Tři roky po vstupu tohoto nařízení v platnost předloží Komise Evropskému parlamentu, Radě a Hospodářskému a sociálnímu výboru zprávu o fungování tohoto nařízení a jeho přínosu k provádění režimu zavedeného rozhodnutím.
Three years after the entry into force of this Regulation, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation and the contribution it has made to the implementation of the system established by the Decision.
Tři roky po vstupu tohoto nařízení v platnost, pak každé tři roky , předloží Komise Evropskému parlamentu, Radě a Hospodářskému a sociálnímu výboru zprávu o fungování tohoto nařízení a o jeho přínosu k provádění režimu zavedeného rozhodnutím.
Three years after the entry into force of this Regulation, and every three years thereafter, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation and the contribution it has made to the implementation of the system established by the Decision.
Komise předloží jakýkoliv návrh pro dosažení změn nezbytných pro zkvalitnění tohoto nařízení.
Where necessary, it shall present proposals for amendments to this Regulation.
Komise předloží Evropskému parlamentu a také Radě jakýkoliv návrh přezkumu tohoto nařízení nezbytný při jakékoliv změně dohody TRIPS.
The Commission shall also present to the European Parliament and the Council any necessary proposals for revising this Regulation when the TRIPS Agreement has been amended.
Publication of reports on implementation must be accompanied, where necessary, by proposals for amendments to Community provisions in order to address gaps found.
Publication of reports on implementation must be accompanied, where necessary, by proposals for amendments to Community provisions in order to address gaps found.
Furthermore, the Commission must propose any amendments to this Regulation necessary in order to take account of amendments to the TRIPS Agreement.
Furthermore, the Commission must propose any amendments to this Regulation necessary in order to take account of amendments to the TRIPS Agreement.
Consistency between the texts should be ensured.
Consistency between the texts should be ensured.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was adopted in April 1994 as part of the results of the Uruguay Round of International Trade Negotiations.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) was adopted in April 1994 as part of the results of the Uruguay Round of International Trade Negotiations.
The TRIPS Agreement combines an extension of basic World Trade Organisation (WTO) law principles to the area of intellectual property (IP), an increase in minimum protection standards for IP, enforcement obligations and provisions relating to dispute settlement.
The TRIPS Agreement combines an extension of basic World Trade Organisation (WTO) law principles to the area of intellectual property (IP), an increase in minimum protection standards for IP, enforcement obligations and provisions relating to dispute settlement.
The significant costs associated with the introduction of higher IP protection standards in developing countries created much discussion on how the TRIPS Agreement could best be implemented in view of developmental concerns.
The significant costs associated with the introduction of higher IP protection standards in developing countries created much discussion on how the TRIPS Agreement could best be implemented in view of developmental concerns.
The most ardently debated issue with regard to developing countries has been the question whether increased patent protection under the rules of the TRIPS Agreement impedes access to affordable medicines in poor countries.
The most ardently debated issue with regard to developing countries has been the question whether increased patent protection under the rules of the TRIPS Agreement impedes access to affordable medicines in poor countries.
At the Doha Ministerial Conference, the debate culminated in the landmark adoption of the “Doha Declaration on the TRIPS Agreement and Public Health”.
At the Doha Ministerial Conference, the debate culminated in the landmark adoption of the “Doha Declaration on the TRIPS Agreement and Public Health”.
In the Doha Declaration, WTO Members stressed that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.”
In the Doha Declaration, WTO Members stressed that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.”
The Doha Declaration mainly affirmed existing flexibilities in the TRIPS Agreement to achieve these goals.
The Doha Declaration mainly affirmed existing flexibilities in the TRIPS Agreement to achieve these goals.
However, paragraph 6 of the Doha Declaration also recognised that countries with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing.
However, paragraph 6 of the Doha Declaration also recognised that countries with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing.
It instructed the Council for TRIPS to find "an expeditious solution to this problem".
It instructed the Council for TRIPS to find "an expeditious solution to this problem".
The Decision of the General Council of the WTO of 30 August 2003 spells out the circumstances under which countries without pharmaceutical manufacturing capacity can import generic versions of drugs still under patent.
The Decision of the General Council of the WTO of 30 August 2003 spells out the circumstances under which countries without pharmaceutical manufacturing capacity can import generic versions of drugs still under patent.
The Decision temporarily waives Members' obligations under TRIPS Article 31(f) by allowing them to export pharmaceuticals produced under compulsory licence, subject to a large number of conditions in both the exporting and importing country.
The Decision temporarily waives Members' obligations under TRIPS Article 31(f) by allowing them to export pharmaceuticals produced under compulsory licence, subject to a large number of conditions in both the exporting and importing country.
In the Decision - the adoption of which was accompanied by a statement from the Chair of the General Council assuring that it would not be misused - Members agreed that the waiver would last until the TRIPS Agreement is permanently amended.
In the Decision - the adoption of which was accompanied by a statement from the Chair of the General Council assuring that it would not be misused - Members agreed that the waiver would last until the TRIPS Agreement is permanently amended.
Until now, Members of the WTO Council for TRIPS were unable to reach consensus on how to formally amend Article 31 of the TRIPS Agreement in order to facilitate the export of drugs produced under compulsory license.
Until now, Members of the WTO Council for TRIPS were unable to reach consensus on how to formally amend Article 31 of the TRIPS Agreement in order to facilitate the export of drugs produced under compulsory license.
The already-extended deadline to do this expired on 31 March 2005.
The already-extended deadline to do this expired on 31 March 2005.
Members will have to discuss how to proceed further.
Members will have to discuss how to proceed further.
The draft regulation
The draft regulation
The draft regulation aims at uniformly implementing, within the European Union, the WTO Decision.
The draft regulation aims at uniformly implementing, within the European Union, the WTO Decision.
The rapporteur welcomes the draft regulation as a positive step forward in the process of implementing the WTO-decision promoting public health in developing countries.
The rapporteur welcomes the draft regulation as a positive step forward in the process of implementing the WTO-decision promoting public health in developing countries.
However the rapporteur believes that the text should be further improved on the following points:
However the rapporteur believes that the text should be further improved on the following points:
2.1 Eligible countries
2.1 Eligible countries
As proposed, the draft Regulation would only benefit WTO member countries.
As proposed, the draft Regulation would only benefit WTO member countries.
The draft Regulation should be an instrument reflecting the link between EU trade and development policies.
The draft Regulation should be an instrument reflecting the link between EU trade and development policies.
Given that problems of lack of affordable medicines are not limited to WTO Member countries, the mutual beneficiality of trade and development policy can not be ensured if the potential beneficiary countries are limited to countries that are members of the WTO.
Given that problems of lack of affordable medicines are not limited to WTO Member countries, the mutual beneficiality of trade and development policy can not be ensured if the potential beneficiary countries are limited to countries that are members of the WTO.
It makes no sense from a public health perspective to limit the application of the system to WTO members.
It makes no sense from a public health perspective to limit the application of the system to WTO members.
Whether a country is a WTO member or not does not constitute a valid criterion for allowing or not exports of low priced drugs to address public health needs.
Whether a country is a WTO member or not does not constitute a valid criterion for allowing or not exports of low priced drugs to address public health needs.
Threats to public health do not recognise such arbitrary legal distinction.
Threats to public health do not recognise such arbitrary legal distinction.
In addition, public health problems in a non-WTO member may have serious implications in WTO members.
In addition, public health problems in a non-WTO member may have serious implications in WTO members.
While the WTO Decision was negotiated in the context of WTO and to benefit its members, WTO law does not restrict WTO Members in extending the implementation of the Decision to non-WTO Members.
While the WTO Decision was negotiated in the context of WTO and to benefit its members, WTO law does not restrict WTO Members in extending the implementation of the Decision to non-WTO Members.
If the EU allows exports of pharmaceutical products under the draft Regulation to WTO members, there is no reason to discriminate against other countries, as long as the conditions set forth by the draft Regulation are complied with.
If the EU allows exports of pharmaceutical products under the draft Regulation to WTO members, there is no reason to discriminate against other countries, as long as the conditions set forth by the draft Regulation are complied with.
Therefore, the scope of the draft regulation should be extended to include also non-WTO Members - both developing countries and least-developed countries - as potential beneficiary countries.
Therefore, the scope of the draft regulation should be extended to include also non-WTO Members - both developing countries and least-developed countries - as potential beneficiary countries.
2.2 Waiver of obligation to negotiate with the patent holder
2.2 Waiver of obligation to negotiate with the patent holder
Under article 31(b) of the TRIPS agreement, the obligation to obtain a voluntary license should be waived in situations of national emergency, other circumstances of extreme urgency and public non-commercial use.
Under article 31(b) of the TRIPS agreement, the obligation to obtain a voluntary license should be waived in situations of national emergency, other circumstances of extreme urgency and public non-commercial use.
In developing countries “public non-commercial use” is the most important ground besides emergency-situations to buy pharmaceutical products in order to face public health problems.
In developing countries “public non-commercial use” is the most important ground besides emergency-situations to buy pharmaceutical products in order to face public health problems.
Therefore “public non-commercial use” should be included in the draft regulation as a ground for waiving the obligation.
Therefore “public non-commercial use” should be included in the draft regulation as a ground for waiving the obligation.
2.3 Timeframe for the negotiation with the patent holder
2.3 Timeframe for the negotiation with the patent holder
The draft Regulation does not specify the ‘reasonable period of time’ for the prior negotiation with a patentee.
The draft Regulation does not specify the ‘reasonable period of time’ for the prior negotiation with a patentee.
This may create uncertainty and delays that may result in disincentives for generic producers to make use of the system.
This may create uncertainty and delays that may result in disincentives for generic producers to make use of the system.
2.4 Public tendering for pharmaceutical products
2.4 Public tendering for pharmaceutical products
The draft Regulation seems to exclude the possibility of using tendering procedures to purchase the needed pharmaceutical products.
The draft Regulation seems to exclude the possibility of using tendering procedures to purchase the needed pharmaceutical products.
However, international tendering is the preferred way of purchasing medicines and other medical supplies and is also often required by bilateral donors.
However, international tendering is the preferred way of purchasing medicines and other medical supplies and is also often required by bilateral donors.
2.5 Non-governmental procurement of medicines
2.5 Non-governmental procurement of medicines
Under the WTO Decision the importing country has to make a notification to the TRIPS Council, specifying the names and expected quantities of the products needed.
Under the WTO Decision the importing country has to make a notification to the TRIPS Council, specifying the names and expected quantities of the products needed.
However, this does not exclude that the importing country authorises another entity, such as the United Nations or an non-governmental organisation (NGO), to contract with a licensee in order to procure and distribute the medicines.
However, this does not exclude that the importing country authorises another entity, such as the United Nations or an non-governmental organisation (NGO), to contract with a licensee in order to procure and distribute the medicines.
Under the Regulation the request can only come ‘from authorised representatives’ of the importing country.
Under the Regulation the request can only come ‘from authorised representatives’ of the importing country.
This requirement, absent in the WTO Decision, may be interpreted as excluding the importation under the system by NGOs, as well as from other organisations, such as the United Nations.
This requirement, absent in the WTO Decision, may be interpreted as excluding the importation under the system by NGOs, as well as from other organisations, such as the United Nations.
Several NGOs, in particular, play an important role in the supply of health care services and treatment (e.g. for HIV/AIDS patients) in developing countries and LDCs, and work in areas struck by disasters, war or other circumstances where government authorities cannot reach people in need.
Several NGOs, in particular, play an important role in the supply of health care services and treatment (e.g. for HIV/AIDS patients) in developing countries and LDCs, and work in areas struck by disasters, war or other circumstances where government authorities cannot reach people in need.
Therefore the request from a NGO, acting with the authorisation of one or more importing countries, should also be eligible.
Therefore the request from a NGO, acting with the authorisation of one or more importing countries, should also be eligible.
2.6 Re-exportation to members of a regional trade agreement
2.6 Re-exportation to members of a regional trade agreement
The draft Regulation seems to exclude the possibility of export within a regional trade agreement.
The draft Regulation seems to exclude the possibility of export within a regional trade agreement.
Paragraph 6 of the WTO Decision permits the re-exportation of products imported under the system to other members of a regional trade agreement at least half of the membership of which is made up of LDCs.
Paragraph 6 of the WTO Decision permits the re-exportation of products imported under the system to other members of a regional trade agreement at least half of the membership of which is made up of LDCs.
2.7 Product differentiation
2.7 Product differentiation
The burden of proof is shifted, in a way that makes more difficult and less attractive for prospective suppliers to use the system.
The burden of proof is shifted, in a way that makes more difficult and less attractive for prospective suppliers to use the system.
Differentiation of the formulation would imply longer periods for registration in the exporting and in the importing country, since proof of bioequivalence is dependent on substantial similarity in formulation and dosage.
Differentiation of the formulation would imply longer periods for registration in the exporting and in the importing country, since proof of bioequivalence is dependent on substantial similarity in formulation and dosage.
Moreover, such differentiation may lead to reduced adherence with a treatment regime.
Moreover, such differentiation may lead to reduced adherence with a treatment regime.
2.8 Adequate remuneration
2.8 Adequate remuneration
The draft Regulation, consistently with the WTO Decision, requires the compulsory licence to pay an adequate remuneration to the patentee "taking into account the economic value of the use that has been authorised under the licence to the importing WTO member(s) concerned".
The draft Regulation, consistently with the WTO Decision, requires the compulsory licence to pay an adequate remuneration to the patentee "taking into account the economic value of the use that has been authorised under the licence to the importing WTO member(s) concerned".