One of the most heated debates relating to global health is undoubtedly the impact of the patents system on the cost of and access to essential medicines in developing countries. This post aims to quickly revisit the “A2M SAGA” and its new challenges, in particular in view of the need to address access to new drugs (e.g. second-lines) and the NCD global epidemic.
SETTING THE SCENE: THE ROLE OF PATENTS IN THE ACCESS TO MEDICINES DEBATE
While there is no denying that access to medicines is a complex issue implicating questions of quality, procurement, distribution, health systems and so on, the cost is a major factor behind the lack of access in developing countries. The monopoly conferred by patent rights enables pharmaceutical manufacturers to impose a high price on a medicine during 20 years. All high and middle-income countries have to grant patent rights on medicines by virtue of an international agreement of the World Trade Organization, namely, the Agreement on Trade-Related Aspects of Intellectual Property Rights (“the TRIPS “). However, the TRIPS also provides a series of flexibilities that countries can rely upon in prioritizing public health over patents.
This is what the black-letter law says. But how law is actually understood and implemented is a different matter. Indeed, some countries, taking up the case for their pharmaceutical industry, tend to have a very extensive view of patent rights and put pressure on developing countries that are willing to improve access to low-cost generics.
The recent Documentary, “Fire in the Blood” revisits the intense battles which have been fought by civil society in the past 10 years in this regard. In particular, it goes back to the momentum of access to ARVs generated in the early 2000’s. Indeed, the price of the first generation of HIV drugs came down dramatically from over $10,000 per patient per year to around $67 in 2010 thanks to the availability of generics. The “HIV momentum” also led to the adoption of the Doha Declaration in 2001, which recalls the rights to prioritize patients over patents.
Reminding the “Good, the Bad and the Ugly”, the “Constant Gardener” and “Breaking Bad”, this pitch has all the elements of a good story: David vs Goliath, worldwide Robin Hoods and historic wins … But where do we stand 12 years after Doha? And, what are the new challenges?
NEW CHALLENGES IN THE ACCESS TO MEDICINES DEBATE
Most middle-income countries are now applying the TRIPS and have to resort to specific flexibility mechanisms to continue to produce low-cost generics. The need for accessing generics is more pressing than ever. The rise of NCDs and related costly drugs, for example, for oncology drugs, call for national laws that would make the most out of the public health safeguards of the TRIPS agreement.
India and cancer drugs: In its 2005 IP law, India adopted a restrictive approach which consists in granting patents only to “new” drugs, refusing thus to grant patents to new forms of existing medicines. Countries are free to decide their interpretation of the patentability criteria (for example, the US FDA has an extensive view of the novelty requirement that results in renewing the 20 years patents for other forms of the same drug – see on this the recent NYT article – a must-read: the-soaring-cost-of-a-simple-breath). However, Novartis questioned the legality of this interpretation and decided to sue the Indian government. After 7 years of legal proceedings, the Indian Supreme Court recently decided to reject Novartis claims.
India is now considering granting several compulsory licenses for production of generic versions of some costly cancer drugs, which constitute a major source of revenue for pharmaceutical industries. While there seems to be nothing wrong with this from a legal standpoint, something tells me that it would not be an easy step (see this recent post from MSF).
With the global target of access to 80% of essential medicines for NCDs, including cancer, set forth in the WHO Global Action Plan adopted by the WHA in May 2013, much remains to be done in this area, beginning with the update of the cancer section of the WHO Model list of Essential Medicines and finding out the best balance in terms of IP when optimizing access to essential cancer medicines in LMICs (see in particular the very interesting article recently published on the role of generic medicines in oncology in low-income countries).
New laws in Brazil and South Africa: In view of similar challenges to ensure sustainable access to essential medicines, including for NCDs, Brazil and South Africa are starting to rethink their patent laws to make a full usage of the TRIPS flexibilities.
Indeed, the South African patent law, as it is implemented today, is regarded by the civil society as a clear impedement to the affordability of medicines.
These are only some tips of the iceberg in a saga which increasingly challenges the very viability of the patent system. The recent postponing sine die of the project of a global treaty on R&D foreshadows that adjusting the system of global protection of intellectual rights to strike a balance between affordability and innovation will not be easy.
The saga is thus likely to continue for long …
- Bollyky TJ, “Access to Drugs for Treatment of Noncommunicable Diseases”, PLoS Med, July 2013, 10(7).
- Hayden E.C., “India spurns cancer patents”, Nature, August 2013.
- Lexchin J., “Canada and access to medicines in developing countries: intellectual property rights first”, Global Health, 2013.
- Renner L., Nkansah F.A., Dodoo A.N., “The Role of Generic Medicines and Biosimilars in Oncology in Low Income Countries”, Annals of Oncology, Sept. 2013.
- Brazilian Deputy Center for Strategic Studies and debates, Brazilian Patent Reform: Innovation Towards Competitiveness, Brazilia, October 2013.