natgillin/translations-raw huggingface dataset:
This provision does not provide any direction as to what constitutes adequate remuneration.
This provision does not provide any direction as to what constitutes adequate remuneration.
The absence of predictability creates considerable uncertainty for prospective users of the system (both potential producer companies and importers of pharmaceutical products) and may give rise to litigation as to whether the determined remuneration is adequate.
The absence of predictability creates considerable uncertainty for prospective users of the system (both potential producer companies and importers of pharmaceutical products) and may give rise to litigation as to whether the determined remuneration is adequate.
The specification of what is to be considered “adequate remuneration” will also provide guidance on what would be considered a “reasonable royalty” to be agreed upon in negotiations on a voluntary licence between the patent holder and the generic producer.
The specification of what is to be considered “adequate remuneration” will also provide guidance on what would be considered a “reasonable royalty” to be agreed upon in negotiations on a voluntary licence between the patent holder and the generic producer.
In order to enhance the predictability of the remuneration, the Commission should establish guidelines.
In order to enhance the predictability of the remuneration, the Commission should establish guidelines.
2.9 Technology transfer and capacity building
2.9 Technology transfer and capacity building
The establishment of local manufacturing capacity is an important element in order to ensure that countries with insufficient or no manufacturing capacity in the pharmaceutical sector could make effective use of compulsory licensing.
The establishment of local manufacturing capacity is an important element in order to ensure that countries with insufficient or no manufacturing capacity in the pharmaceutical sector could make effective use of compulsory licensing.
In the WTO Decision, WTO Members recognise the desirability of technology transfer and capacity building in the pharmaceutical sector.
In the WTO Decision, WTO Members recognise the desirability of technology transfer and capacity building in the pharmaceutical sector.
Therefore, the Regulation should specify that the Community recognises the necessity of promoting technology transfer and capacity building in the pharmaceutical sector in order to overcome the problem recognised in paragraph 6 of the Doha Declaration.
Therefore, the Regulation should specify that the Community recognises the necessity of promoting technology transfer and capacity building in the pharmaceutical sector in order to overcome the problem recognised in paragraph 6 of the Doha Declaration.
It should further be specified that the Regulation encourages the use of the established system in a way that would promote such technology transfer and capacity building.
It should further be specified that the Regulation encourages the use of the established system in a way that would promote such technology transfer and capacity building.
Moreover, the Community should actively support the implementation of the WTO Decision in importing countries and the establishment of regional patent systems through its technical assistance activities.
Moreover, the Community should actively support the implementation of the WTO Decision in importing countries and the establishment of regional patent systems through its technical assistance activities.
The Doha WTO Ministerial in 2001 produced a landmark agreement, the Doha Declaration on TRIPS and Public Health, which clearly defined the primacy of public health in relation to intellectual property rights.
The Doha WTO Ministerial in 2001 produced a landmark agreement, the Doha Declaration on TRIPS and Public Health, which clearly defined the primacy of public health in relation to intellectual property rights.
The EC draft regulation aims to provide the detail on the measures needed to implement the subsequent WTO General Council Decision of August 30th 2003 within the European Union.
The EC draft regulation aims to provide the detail on the measures needed to implement the subsequent WTO General Council Decision of August 30th 2003 within the European Union.
The relevant paragraph in the Doha Declaration recognises that WTO members with insufficient, or no manufacturing capacity, in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS agreement.
The relevant paragraph in the Doha Declaration recognises that WTO members with insufficient, or no manufacturing capacity, in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS agreement.
Historically, pharmaceutical companies and governments have argued that the high cost of research and development dictates that there should be strong patent protection, likely to provide incentives for that investment.
Historically, pharmaceutical companies and governments have argued that the high cost of research and development dictates that there should be strong patent protection, likely to provide incentives for that investment.
TRIPS, in theory, exists to reward innovation but, as things stand, the system lacks a mechanism likely to ensure that, in particular, the diseases of the poor and developing country's health priorities are addressed.
TRIPS, in theory, exists to reward innovation but, as things stand, the system lacks a mechanism likely to ensure that, in particular, the diseases of the poor and developing country's health priorities are addressed.
The reality is that only 10% of global research in development are actually directed towards illnesses that account for 90% of the world wide disease burden.
The reality is that only 10% of global research in development are actually directed towards illnesses that account for 90% of the world wide disease burden.
Millions of people in developing countries are dying every year because the only drugs available to treat tropical diseases are either old, toxic or ineffective.
Millions of people in developing countries are dying every year because the only drugs available to treat tropical diseases are either old, toxic or ineffective.
The draft EC regulation is intended to establish the conditions under which compulsory licences for export can be granted.
The draft EC regulation is intended to establish the conditions under which compulsory licences for export can be granted.
However, the test of the current regulation is whether it actually has the potential to maximise developing country access to low-priced, essential medicines through making full use of the flexibilities which clearly are in the WTO text.
However, the test of the current regulation is whether it actually has the potential to maximise developing country access to low-priced, essential medicines through making full use of the flexibilities which clearly are in the WTO text.
Although there has been an acknowledgement by a number of commentators that there are positive elements in the regulation, some concerns remain.
Although there has been an acknowledgement by a number of commentators that there are positive elements in the regulation, some concerns remain.
Indeed, the European Generic Medicines Association has concluded that, "the procedures are complicated, the terms under which new producers must operate are very restrictive and the various measures proposed are ambiguous."
Indeed, the European Generic Medicines Association has concluded that, "the procedures are complicated, the terms under which new producers must operate are very restrictive and the various measures proposed are ambiguous."
The process, therefore, should be simplified in order to encourage European suppliers to operate under the system.
The process, therefore, should be simplified in order to encourage European suppliers to operate under the system.
Clearly, there need to be safeguards which ensure that generic pharmaceutical products do not find their way into the European market.
Clearly, there need to be safeguards which ensure that generic pharmaceutical products do not find their way into the European market.
Since, however, trade in pharmaceutical products is subject to stringent national regulations, the risk of diversion is not high.
Since, however, trade in pharmaceutical products is subject to stringent national regulations, the risk of diversion is not high.
Indeed, the Commission itself has noted that there has been no evidence of the re-importation of medicines from the poorest developing countries into the EU.
Indeed, the Commission itself has noted that there has been no evidence of the re-importation of medicines from the poorest developing countries into the EU.
Therefore, these provisions should not and need not impose unnecessary restrictions.
Therefore, these provisions should not and need not impose unnecessary restrictions.
The fact that the Dutch legislation is less restrictive is an indication that it should be possible to take more advantage of the opportunities which exist in the WTO text to address those public health objectives, which are at the heart of the Doha Declaration.
The fact that the Dutch legislation is less restrictive is an indication that it should be possible to take more advantage of the opportunities which exist in the WTO text to address those public health objectives, which are at the heart of the Doha Declaration.
Regrettably, the regulation consistently applies conditions which are not featured in the WTO decision and which could potentially discourage suppliers.
Regrettably, the regulation consistently applies conditions which are not featured in the WTO decision and which could potentially discourage suppliers.
Serious consideration should now be given to the need for some relaxation of what is an over zealous interpretation of the WTO decision.
Serious consideration should now be given to the need for some relaxation of what is an over zealous interpretation of the WTO decision.
The draft regulation also includes a requirement which does not feature in the WTO decision.
The draft regulation also includes a requirement which does not feature in the WTO decision.
This appears to exclude the right of NGOs and international institutions such as the UN to import medicines under the rules of the regulation under the system, and, indeed, fails to take into account the critical role NGOs play in the supply of healthcare services and treatment.
This appears to exclude the right of NGOs and international institutions such as the UN to import medicines under the rules of the regulation under the system, and, indeed, fails to take into account the critical role NGOs play in the supply of healthcare services and treatment.
In addition, it takes no account of the NGOs' role in, for instance, disasters or conflicts, where governments, for whatever reason, cannot be present.
In addition, it takes no account of the NGOs' role in, for instance, disasters or conflicts, where governments, for whatever reason, cannot be present.
Again, we should note that the Dutch regulation includes a clear reference to the role of NGOs.
Again, we should note that the Dutch regulation includes a clear reference to the role of NGOs.
Also, unlike the EC regulation, the Canadian, Norwegian and Dutch regulations all include clear reference to non-WTO members - 40 of which are least developed countries.
Also, unlike the EC regulation, the Canadian, Norwegian and Dutch regulations all include clear reference to non-WTO members - 40 of which are least developed countries.
In addition, the EC regulation imposes restrictions which are more severe than those included in the TRIPS agreement.
In addition, the EC regulation imposes restrictions which are more severe than those included in the TRIPS agreement.
Voluntary licences do not need to be negotiated in declared situations of national emergency or other circumstances of extreme urgency.
Voluntary licences do not need to be negotiated in declared situations of national emergency or other circumstances of extreme urgency.
The EC regulation in fact does not apply these exceptions, and is therefore applying so-called "TRIPS plus" conditions.
The EC regulation in fact does not apply these exceptions, and is therefore applying so-called "TRIPS plus" conditions.
This regulation should therefore not be seen as the last word and it should be understood that a further review and assessment will be necessary.
This regulation should therefore not be seen as the last word and it should be understood that a further review and assessment will be necessary.
It does, in fact, call for an annual report on the implementation of its recommendations.
It does, in fact, call for an annual report on the implementation of its recommendations.
It should also be noted that the WTO decision allows for such an annual review.
It should also be noted that the WTO decision allows for such an annual review.
We also require greater clarity on provisions for further action.
We also require greater clarity on provisions for further action.
Indeed, any future amendment of TRIPS in order to incorporate the WTO decision would, it seems, require an immediate review of the EC regulation and its operation should be monitored at regular intervals.
Indeed, any future amendment of TRIPS in order to incorporate the WTO decision would, it seems, require an immediate review of the EC regulation and its operation should be monitored at regular intervals.
Issues related to the transfer of technology to developing countries, as well as the need for capacity building in the production of pharmaceuticals, are a serious omission from the draft regulation.
Issues related to the transfer of technology to developing countries, as well as the need for capacity building in the production of pharmaceuticals, are a serious omission from the draft regulation.
These elements are clear objectives of the WTO decision.
These elements are clear objectives of the WTO decision.
There needs to be a clear understanding that the research and development of medicines is a global, public good and, therefore, requires global action including sustainable and long-term financing, including through the Seventh Framework Programme.
There needs to be a clear understanding that the research and development of medicines is a global, public good and, therefore, requires global action including sustainable and long-term financing, including through the Seventh Framework Programme.
The European Parliament's study by Carlos Correa (Directorate General External Policies) estimates that the impact of the draft regulation on developing country health problems "will probably be modest".
The European Parliament's study by Carlos Correa (Directorate General External Policies) estimates that the impact of the draft regulation on developing country health problems "will probably be modest".
It is therefore a matter of some concern that its ability to meet the Doha vision of how we "promote access to medicines for all" could remain elusive.
It is therefore a matter of some concern that its ability to meet the Doha vision of how we "promote access to medicines for all" could remain elusive.
Clearly much remains to be done - both in terms of adequate funding and ensuring flexible intellectual property frameworks.
Clearly much remains to be done - both in terms of adequate funding and ensuring flexible intellectual property frameworks.
Výbor pro rozvoj vyzývá Výbor pro mezinárodní obchod jako příslušný výbor, aby do své zprávy začlenil tyto pozměňovací návrhy:
The Committee on Development calls on the Committee on International Trade, as the committee responsible, to incorporate the following amendments in its report:
Toto nařízení stanoví postup pro udělování nucených licencí v souvislosti s patenty a dodatkovými ochrannými osvědčeními týkajícími se výroby a prodeje farmaceutických výrobků, jestliže jsou tyto výrobky určeny pro vývoz do oprávněných zemí.
This Regulation establishes a procedure for the grant of compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible countries.
The proposed regulation would exclude non-WTO members from the provisions, including 40 LDCs.
The proposed regulation would exclude non-WTO members from the provisions, including 40 LDCs.
If we are achieving the Doha objective of promoting access to medicines for all, this must include these 40 poorest countries.
If we are achieving the Doha objective of promoting access to medicines for all, this must include these 40 poorest countries.
Nothing in the WTO Decision prevents such an extension as is demonstrated by the legislation presented in Norway, Canada and the Netherlands.
Nothing in the WTO decision prevents such an extension as is demonstrated by the legislation presented in Norway, Canada and the Netherlands.
(3) „dovážejícím členem WTO “ se rozumí název člena WTO, kam se má farmaceutický výrobek vyvézt.
(3) “importing WTO member ” means the name of the WTO member to which the pharmaceutical product is to be exported;
(3) „dovážející zemí “ se rozumí název člena WTO nebo nejméně rozvinuté země , kam se má farmaceutický výrobek vyvézt.
(3) “importing country ” means the name of the WTO member or developing country or least developed country to which the pharmaceutical product is to be exported;
Non-WTO-member LDC´s should be able to make use of the system.
Non-WTO-member LDCs should be able to make use of the system.
a) jakákoliv nejméně rozvinutá členská země WTO ,
(a) any least-developed country member of WTO
a) jakákoliv nejméně rozvinutá nebo rozvojová země ,
(a) any least-developed or developing country
Nicméně člen WTO , který před WTO prohlásil, že nebude režim využívat jako dovážející člen WTO , není oprávněným dovážejícím členem WTO .
However, any WTO member that has made a declaration to the WTO that it will not use the system as an importing WTO member is not an eligible importing WTO member .
Nicméně země , který před WTO prohlásil, že nebude režim využívat jako dovážející země , není oprávněným dovážejícím země .
However, any country that has made a declaration to the WTO that it will not use the systems as an importing country is not an eligible importing country .
Jestliže ten, kdo žádá o nucenou licenci, podává žádosti k příslušným orgánům ve více než jednom členském státě na stejný výrobek, vyznačí tuto skutečnost v každé žádosti a uvede informace o množství a předmětných dovážejících členech WTO .
If the person applying for a compulsory licence is submitting applications to competent authorities in more than one Member State for the same product, he shall indicate that in each application, together with details of the quantities and importing WTO members concerned.
Jestliže ten, kdo žádá o nucenou licenci, podává žádosti k příslušným orgánům ve více než jednom členském státě na stejný výrobek, vyznačí tuto skutečnost v každé žádosti a uvede informace o množství a předmětných dovážejících zemích .
If the person applying for a compulsory licence is submitting applications to competent authorities in more than one Member State for the same product, he shall indicate that in each application, together with details of the quantities and importing countries concerned.
The possibility of applying fast-track procedures is of particular importance given the risk of patentees not engaging in negotiations in good faith.
The possibility of applying fast-track procedures is of particular importance given the risk of patentees not engaging in negotiations in good faith.
g) doklad o zvláštním požadavku zmocněných zástupců dovážejícího člena WTO vůči žadateli s označením požadovaného množství výrobku.
(g) evidence of a specific request to the applicant from authorised representatives of the importing WTO member and indicating quantity of product required.
g) doklad o zvláštním požadavku:
(g) evidence of a specific request to the applicant from :
i) - zmocněných zástupců dovážející země nebo dovážejících zemí;
i ) authorised representatives of the importing country or countries;
ii) - nevládní organizace jednající s úředním souhlasem jedné nebo více dovážejících zemí;
ii) a non-governmental organisation acting with the formal approval of one or more importing countries;
iii) - organizací v rámcí OSN nebo jiných mezinárodních zdravotnických organizací jednajících s úředním souhlasem jedné nebo více dovážejících zemí;
iii) organisations from the UN system or other international health organisations acting with the formal approval of one or more importing countries;
vůči žadateli s označením požadovaného množství výrobku.
and indicating quantity of product required.
Countries should be able to file an application together and the system should offer the possibility to NGO´s, organisations of the United Nations or other international health organisations to act for one or more importing countries in the search for a producer and to import the pharmaceutical products in the importing countries.
Countries should be able to file an application together and the system should offer the possibility to NGOs, organisations of the United Nations or other international health organisations to act for one or more importing countries in the search for a producer and to import the pharmaceutical products in the importing countries.
Příslušný orgán smí stanovit další formální nebo administrativní požadavky na účinné zpracování žádosti.
The competent authority may prescribe additional formal or administrative requirements for efficient processing of the application.
This requirement is absent from the WTO Decision and adds unnecessary complication.
This requirement is absent from the WTO Decision and adds unnecessary complication
Příslušný orgán ověří, zda každý dovážející člen WTO uvedený v žádosti podal WTO oznámení v souladu s rozhodnutím Generální rady WTO ze dne 30. srpna 2003 o provádění odstavce 6 prohlášení z Doha o dohodě TRIPS a veřejném zdraví (dále jen „rozhodnutí“) v souvislosti s každým výrobkem uvedeným v žádosti, která:
The competent authority shall verify that each importing WTO member cited in the application has made a notification to the WTO pursuant to the Decision of 30 August 2003 of the General Council of the WTO on the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, hereinafter “the Decision” in respect of each of the products covered by the application that:
Příslušný orgán ověří, zda každá země uvedená v žádosti podala WTO oznámení v souladu s rozhodnutím Generální rady WTO ze dne 30. srpna 2003 o provádění odstavce 6 deklarace z Doha o dohodě TRIPS a veřejném zdraví (dále jen „rozhodnutí“) v souvislosti s každým výrobkem uvedeným v žádosti, která:
The competent authority shall verify that each country cited in the application has made a notification to the WTO pursuant to the Decision of 30 August 2003 of the General Council of the WTO on the implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, hereinafter “the Decision” in respect of each of the products covered by the application that:
b) jestliže dovážející člen WTO není nejméně rozvinutou zemí, potvrdí zjištění dovážejícího člena WTO , že buď nemá žádné výrobní kapacity ve farmaceutickém odvětví nebo své výrobní kapacity v tomto odvětví prověřil a zjistil, že jeho kapacity, vyjma kapacity vlastněné nebo ovládané držitelem práva, nepostačují v současné době k naplnění potřeb;
(b) unless the importing WTO member is a least-developed country, confirms that the importing WTO member has established that it either has no manufacturing capacities in the pharmaceutical sector or has examined its manufacturing capacity in that sector and found that, excluding any capacity owned or controlled by the right holder, it is currently insufficient for meeting its needs;