92. Switzerland welcomed the entry into force of the revised TRIPS Agreement, incorporating the Paragraph 6 solution. While the Paragraph 6 mechanism could already be used since 2003 through the waiver decision, inserting the new Article 31bis into the TRIPS Agreement clearly adds transparency, clarity and legal certainty. It is also a positive signal illustrating that the WTO and its Members are willing and able to recognise relevant public policy challenges and find appropriate solutions to them. Switzerland ratified the amendment back in 2006 as the second WTO Member. We implemented the special compulsory licensing system in our national legislation in 2008.
93. Article 31bis of the TRIPS Agreement addresses the particular situation of developing countries with insufficient or no manufacturing capacity in the pharmaceutical sector. It removes a potential legal barrier for countries without a relevant pharmaceutical manufacturing industry to use the instrument of a compulsory license that may have occurred otherwise under Article 31(f) of the TRIPS Agreement. The new System was used when Rwanda imported medicines under the Paragraph 6 mechanism from Apotex in Canada.
94. The Paragraph 6 solution has been criticised earlier by some delegations and certain civil society actors as being complex and burdensome. My delegation disagrees with this view. We have not heard in the Council's past Paragraph 6 reviews from potential beneficiary Members about hurdles that they would have faced when wishing to make use of the mechanism. The WTO Secretariat has provided on its website an illustrative guide on how to use the Paragraph 6 mechanism efficiently, and we believe it demonstrates how straightforward this use can be.
95. Claims that the System is not working simply because it has been used only once so far are jumping to conclusions. A more likely explanation is that other modalities, instruments or mechanisms are just as, if not more relevant and efficient to facilitate access to pharmaceutical products, and are being made use of more regularly. In our view, it is wrong to consider the Paragraph 6 solution and the new Article 31bis as a silver bullet to the access to medicines issue. We should avoid raising overstated expectations of what the TRIPS Agreement can contribute.
96. Article 31bis is a special compulsory license. Compulsory licenses are a flexibility foreseen in the TRIPS Agreement. They may be used, provided a number of circumstances are present and conditions are fulfilled. However, my delegation considers compulsory licences, whether under Article 31 or Article 31bis of the TRIPS Agreement, neither an efficient nor a simple tool to use to gain quick access to essential medicines. Compulsory licensing may overcome a patent-related barrier. However, most of the time, other barriers are present, as well. Lack of infrastructure, of diagnostics and health care personnel, insufficient provider or patient knowledge may come into play and prevent access. Insufficient or inexistent public health care, mark-ups by intermediaries or customs duties imposed by governments also impact on affordability.
97. Pharmaceutical companies, whether R&D originators or generic manufacturers, need financial incentives to invest in the manufacturing of relevant medical products, i.e. a fair return on their investment. Even the production of medical products under a compulsory license costs money and so does getting the relevant marketing authorisation by regulatory agencies.
98. Many countries face challenges related to access to medical products. It is important to address these challenges in a holistic and sustainable manner. Switzerland has been a long-time supporter of strengthening health systems and sustainable financing, including through domestic resources. Our Government sees this as one of the primary avenues to facilitate access to medical products.
99. Instead of advocating the use of compulsory licenses, which are by nature contentious in their approach, this delegation strongly believes in the promotion of initiatives and approaches that incentivise research and development, add transparency, bring potential partners together to make use of synergies and, by the same token, improve access to affordable medical products for people in low- and middle-income countries.
100. We believe that building on voluntary and inclusive efforts, such as the Medicines Patent Pool, the Global Fund's e-procurement platform, WIPO Re:SEARCH, product development partnerships, such as DNDi, or the recent patent information transparency partnership Pat INFORMED launched by WIPO and the private sector, are the way forward and correspond to the collaborative spirit of the 2030 Agenda for Sustainable Development.
101. Switzerland has no comments on the draft report apart from expressing our gratitude to the Secretariat for preparing it.
102. As concerns the further extension of the period of acceptance, my delegation has, as others, a preference for a fixed deadline. This corresponds with the WTO as a rules-based organisation guided by procedures and deadlines. However, Switzerland is flexible whether this extension shall be for another two or four years and will, in this regard, join Members' consensus.
