Title: Regional training for patent office representatives
Date: 4 June, 2019
Venue: Kyiv, Ukraine
Organizers: The South Centre, International Treatment Preparedness Coalition (ITPC Global), Scientific Research Institute of Intellectual Property (National Academy of Law Sciences of Ukraine) and All-Ukrainian Network of People Living with HIV
South Centre Statement on Access to Biosimilars/Biogeneric Medicines at the WHA 72
The revision of the guidelines on similar therapeutic products mandated by Resolution WHA67.21 is crucial for promoting the availability of and access to biosimilars. The reduction in prices ensuing from the introduction of these products has become essential to address public health needs in developed and developing countries. The WHO Document A72/59 under consideration by the WHA 72 (agenda item 21.3) states in paragraph 80 that “WHO expert committees have approved guidance on (…) biotherapeutics, including an update of the 2009 similar biotherapeutic products guidelines”. This statement is not accurate, as the guidelines were not updated as mandated by Resolution WHA67.21. Below is the South Centre statement in relation to this issue.
The US-Mexico-Canada Agreement: Putting Profits Before Patients
In the US-Mexico-Canada Agreement (USMCA, NAFTA 2.0), the U.S. Trade Representative negotiated intellectual property provisions related to pharmaceuticals that would enshrine long and broad monopolies. This policy brief focuses primarily on the negative effects of the USMCA intellectual property provisions on access to medicines in the U.S. Such effects may be even worse for Canada and Mexico. The impact of this trade agreement goes well beyond the three countries involved as this is the first one negotiated by the Trump Administration and is likely to set a precedent for future trade agreements. A careful review of the USMCA text raises very serious concerns about the impact that this agreement would have on the generic/biosimilar industry and therefore on access to more affordable drugs throughout the world.
The ‘obvious to try’ method of addressing strategic patenting: How developing countries can utilise patent law to facilitate access to medicines
The current patentability standards for pharmaceutical inventions, as well as strategic patenting used by pharmaceutical companies, have substantially impacted access to affordable medicines. This has been especially detrimental for developing countries, which are under significant pressure to remain compliant with their international and bilateral obligations, while also providing their people with essential drugs. In order to improve access to medicines, developing countries may choose from a range of various mechanisms that may help to facilitate such access, while also allowing them to remain compliant with their international and bilateral obligations. This policy brief suggests that one of such mechanisms is to strengthen the obviousness requirement by applying the ‘obvious to try with a reasonable expectation of success’ test to pharmaceutical follow-on inventions. It is argued that the application of this test may be an effective tool in addressing the negative effect of strategic patenting. It may help to prevent the extension of patent protection and market exclusivity of existing drugs by pharmaceutical companies and, as a result, may open such medicines up to generic competition.
Will the Amendment to the TRIPS Agreement Enhance Access to Medicines?
An amendment to the TRIPS Agreement by incorporation of the text of the decision of the WTO General Council on 30 August 2003 (as article 31bis) has been made in response to the problem identified in paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. This paragraph sought a solution to situations where patented pharmaceuticals which are not available in a country with no or insufficient manufacturing capacity can be supplied by a foreign provider. As originally adopted, the TRIPS Agreement did not allow the grant of compulsory licenses for exports only, thereby preventing generic manufacturers from exporting the required products to countries unable to produce them. While the new article 31bis is a step forward as it reflects public health concerns, it would be necessary to streamline the procedures to effectively ensure broader access to pharmaceutical products at low cost and in a timely manner.
The Use of TRIPS Flexibilities for the Access to Hepatitis C Treatment
In late 2013, a new Hepatitis C treatment called direct-acting antivirals (DAAs) was introduced in the market at unaffordable prices. The eradication of the disease is possible if medicines can be purchased at AFFORDABLE prices within health budgets. IF THIS IS NOT THE CASE, governments should consider the use of the TRIPS flexibilities to facilitate access to the treatment.
The South Centre is pleased to announce that it is scaling up its services to developing country governments in the area of intellectual property rights and public health, thanks to the support of Unitaid. The project “Expanding the use of TRIPS flexibilities to promote affordable access to medicines” will allow the South Centre to roll out a number of training activities at regional and national level and a global advisory service on the use of TRIPS flexibilities for public health.
South Centre Statement for the Informal Consultation on the Roadmap on Access to Medicines
The draft roadmap is an important work in progress that needs to be further detailed with clear deliverables and timelines. The roadmap will need to ensure complementarity of its work and the implementation of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA).
The International Debate on Generic Medicines of Biological Origin
The debate on generic medicines is not new. What makes it different today is that attacks levelled against biological generic products are couched in even more “technical” and abstruse language. The high price of biological drugs stems mainly from the introduction of barriers to the entry of generics into the market. In any debate on the feasibility of producing biological generic products identical to the ‘original’ ones, it should be made clear that what are at stake are not identical products but therapeutic equivalents.