Access to Medicines Program

The Access to Medicines Program aims to strengthening civil society organizations to improve health public policies and to increase access to  essential medicines, especially through overcoming intellectual property (IP) barriers. Under this program FGEP assumed a noticeable role since it has filed oppositions to patent applications, defending the Argentine ‘Joint Resolution’ that approves guidelines for chemical and pharmaceutical patents (Joint Resolution N° 118/2012, 546/2012 y 107/2012) as well as presenting technical recommendations for regulatory and political reforms that promote the issuance of compulsory licenses. In this way, through legal and advocacy actions we aim to use and defend public health protection tools in order to increase access to essential medicines, promoting the usage of TRIPS’ health safeguards.

In order to achieve this, the program is supported by four basic strategies:

 

 1) Legislative changes

FGEP focuses on:

  • Advocating for legislative reforms to expand and strengthen patentability criteria in favor of public health, the patent opposition system and the mechanism of voluntary licenses issuance in Argentina.
  • Holding an interdisciplinary dialogue on public policies with high-level stakeholders (officials from the Argentine Government, the Patent Office, the Ministry of Health and the Ministry of Industry, and with organizations and representatives of PLHIV and other highly vulnerable groups).
  • Making visible the impact that the regulatory reform of IP would have on public health, through a comprehensive communication strategy.

 

2) Advocacy

FGEP advocates for the maintenance and implementation of the Joint Resolution N°. 118/2012, 546/2012 and 107/2012 that approves guidelines for the patentability exam of patent applications of chemical and pharmaceutical inventions and focuses on:

  • Monitoring the implementation of the patentability guidelines (Joint Resolution N° 118/2012, 546/2012 y 107/2012)
  • Defending the resolution against judicial challenge of pharmaceutical lobbies. Since the patentability guidelines have been attacked by pharmaceutical companies, FGEP considers important to monitor its correct implementation to guarantee the patent system transparency.
  • Promoting the official adoption of:
  1. Bylaws resolutions within the Patent Office (INPI) that give priority to pharmaceutical patents with high relevance in public health.
  2. A presidential decree that regulates the National Patent Law, and includes patentability criteria that defend public health.

FGEP has set up a strategic alliance to defend pro-health public policies relevant to health with both the Ministry of Health and the Ministry of Industry, and since then they have been working together on improving access to medicines and treatments for HIV and HepC and the mitigation of IP-related barriers.

FGEP has achieved to influence decision making processes regarding HIV/AIDS public policies within the Ministry of Health. Through several meeting and workships, FGEP has managed to influence decisions around these topics that have had an important impact on the regional and global policy on HIV:

  • Purchase of generic version of TDF+FTC+EFV: FGEP has been making interventions and advocating for the purchase of generic medicines since 2013, holding meetings with various government authorities, issuing declarations that evidenced the savings generated through the purchasing of generic medicines from India and filing patent oppositions to patent application requested by Gilead & Bristol Myers Squibb. Recently, the buying of generic medicines from CIPLA by the Ministry of Health resulted in a cost reduction of AR$ 181.026.130, which had a very positive impact on the sustainability of the free and universal procurement of medicines programs, and the general access and availability of HIV essential medicines.
  • The addition of a new goal to UNAID’s 90-90-90 Strategy: FGEP proposed Argentine Government to include a fourth goal (‘4th 90’) in the local adoption of this Strategy: that 90% of medicines and other medicinal products be acquired at reasonable prices. The aim of this new goal is to guarantee availability and access to HIV medicines, prevention and diagnosis equipment for all. After a meeting with the UNAIDS Director, Michael Sidibé, the Ministry of Health insisted on the adoption of “the fourth 90” in the global agenda. The UNAIDS´s Director complimented the proposal and stated that ‘it is an strategy that should be implemented worldwide’.

 

 

3) Patent opposition

FGEP aims to file pre-grant patent oppositions on ARVs and other essential medicines to treat HIV/AIDS and Hepatitis C. This proposal is aligned with the Doha Declaration, which establishes that members of the WTO can freely exercise provisions in order to safeguard health from TRIPS measures.

FGEP has filed three oppositions at the Patent Office in Argentina (INPI) in collaboration with Redar Positiva on the following essential medicines:

  •    ATRIPLA® (Efavirenz+Tenofovir+Emtricitabina).
  •    TRUVADA®(Tenofovir 300mg + Emtricitabina 200mg (TDF+FTC)).
  •    SOVALDI® (Sofosbuvir) for Hepatitis C.

 

4) Compulsory licenses

FGEP aims to promote the issuance of compulsory licenses in order to enhance access to medicines. Following these strategies, FGEP is working:

  • To analyze the implementation of compulsory licenses and to explore reasons why it has not been implemented in our country yet.
  • To develop legislative reform strategies to promote proper use of compulsory licenses.
  • To maintain dialogue with the government about the issuance of compulsory licenses on essential medicines.
  • To submit a formal request, asking for the issuance of compulsory licenses.

FGEP is also investigating the feasibility of the implementation of compulsory licenses in Argentina.