EU-Mercosur FTA puts at risk access to medicines in Brazil, new impact assessment study finds

EU-Mercosur FTA puts at risk access to medicines in Brazil, new impact assessment study finds


  • Marcela Fogaça Vieira – human rights and IP lawyer, master in Public Health, consultant Shuttleworth Foundation
  • Gabriela Costa Chaves – pharmacist, PhD in public health, researcher at Department of Medicines Policy and Pharmaceutical Services (NAF), Sergio Arouca National School of Public Health, Oswaldo Cruz Foundation (ENSP/Fiocruz)

The European Union (EU) is currently negotiating a free trade agreement (FTA) with the four founding members of Mercosur (Argentina, Brazil, Paraguay and Uruguay), which comprises a chapter on intellectual property rights (IPR). A new round of negotiations is taking place from November 29th to December 8th in Brussels[1]. Word is that they aim to announce the closure of the agreement at the next World Trade Organization (WTO) Ministerial Conference that will be held from 10-13 of December in Buenos Aires and the clock is ticking to close all the chapters before that. As usual, the negotiations are taking place in secrecy, but the EU released a draft proposal of the IPR chapter in September last year, which has provided the general public some knowledge about what is been negotiated. Continue reading

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South Centre statement on EU-MERCOSUR trade negotiations


South Centre statement on EU-MERCOSUR trade negotiations

EU-MERCOSUR trade negotiations must not impose TRIPS Plus provisions on protection and enforcement of intellectual property rights.

The South Centre is deeply concerned over intellectual property rights (IPRs) provisions put forward by the European Commission in the negotiations for a free trade agreement (FTA) between the European Union and the Mercosur. Continue reading

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Hepatitis C: In Argentina INPI rejected a key patent on Sofosbuvir

Argentina has made an important step forward to protect  local production of generics of an essential medicine to treat Hepatitis C. This brings significant advantages for Public Programs which procure the medicines.

Buenos Aires, December 4, 2017. In Argentina, the INPI (National Institute of Industrial Property) rejected GILEAD PHARMASSET LLC patent application on Sofosbuvir prodrug, an essential medicine to treat HepC.

The resolution PN 066898 of INPI that rejects the patent, is based on the same arguments filed by FGEP in the oppositions. In May, 2015, FGEP filed an opposition in which we highlighted Gilead does not comply with the legal requirements of Argentine patent Law. The article 4 requires novelty, inventive step and industrial application. In addition, the Law in articles 12 and 20 requires the invention must be described in the application in a sufficiently clear and complete manner. All requirements that were not met by Gilead application. Continue reading

Posted in Hepatitis C, Patent, Sofosbuvir, Uncategorized | Leave a comment

Moment of truth for global TB response

On Thursday 16 November 2017, Russian president Vladimir Putin told a hall full of health ministers in Moscow that TB is a “serious problem”, and said, “I am confident that the only way we can stand up against this truly global threat is if we join forces.” Over the next day and a half, the meeting at which President Putin was speaking – the first World Health Organisation (WHO) Global Ministerial Conference: Ending Tuberculosis in the Sustainable Development Era – positively resonated with such talk of the “urgency” of the TB crisis, and calls to “work together”. Continue reading

Posted in BRICS, R&D, Tuberculosis (TB), Uncategorized | Leave a comment

TWN Health Info: WHO’s Study on Substandard and Falsified Medical Products: Questionable Data and Analysis

Geneva, 28th November (Third World Network): There are significant concerns
that WHO’s study on public health and socio economic impact of substandard
and falsified medical products to be released during a press conference
today afternoon in Geneva, is based on questionable data, lacking in
rigorous analysis.

A virtual press conference (VPC) is being organised at CET 15to launch a
report on the Global Surveillance and Monitoring System (GSMS) and a study
on substandard and falsified medical products. Continue reading

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Medicines Excitement in the Netherlands – New Health Minister announces firm action on “absurd” medicines pricing and gets the European Medicines Agency.

The new Minister of Health of the Netherlands, Bruno Bruins, came in guns blazing when he put the pharmaceutical industry on notice and announced on 22 November to “change the rules of the game” to tackle, what he called “absurd” medicines pricing.

He specifically told the Dutch parliament that he plans to “extensively explore” the use of compulsory licensing of patents of medicines that are too expensive. (See here for media coverage in Dutch). Compulsory licensing lifts the monopoly effect of a patent by allowing others to produce generic versions. The Dutch patent law provides for compulsory licensing, including for reasons of public interest, which presumably covers addressing “absurd pricing” of needed medicines.  EU medicines regulations may stand in the way of the Minister’s plans when data exclusivity rules prevent the registration of the generic. For a detailed discussion of the need to ensure coherence in EU law on this matter see our paper here. He will also explore if he can authorise pharmacists to prepare medicines al lower cost for individual patients. Continue reading

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Doctors Without Borders contests Pfizer’s patent on pneumonia vaccine

Pfizer has come under fire for holding exclusive patent rights that bars competition on its pneumonia vaccine worldwide, which is being challenged in patent litigations in several countries, an aid group said Monday.

Doctors Without Borders will challenge Pfizer in the High Court of Delhi in India Tuesday to overturn a patent court ruling that granted the pharmaceutical giant a “monopolistic” control over a pneumonia vaccine, Prevnar 13, it said. Continue reading

Posted in Patent, Patent examination system, Patent Opposition, Uncategorized, Vaccines | Leave a comment