Swiss Member of Parliament Hildegard Fässler-Osterwalder has asked the Swiss government for clarification and official positioning regarding the data protection issue in the European Free Trade Association-India FTA.
She notes the role of India as the main source of pharmaceuticals for the world’s poor, and points to warnings from the UN Special Rapporteur for the Right to Health and UNAIDS that overly strong data protection can harm the right to health. (The European Free Trade Association consists of Norway, Switzerland, Iceland and Lichtenstein, and its agreement with India is separate from the EU-India FTA, also currently under negotiation.)
An unofficial translation of the interpollation from Patrick Durisch from the Berne Declaration follows –
Interpellation Nr 11.4079 introduced at the Swiss Parliament by Hildegard Fässler (Swiss Socialist Party MP) on 19/12/2011
Original in German; ´Quick & Dirty´ translation in English made by Patrick Durisch/The Berne Declaration
Interpellation (Parliamentary intervention)
India as the “Pharmacy of the developing world” – securing access to affordable medicines
Switzerland requests a broadening of intellectual property rights that would encompass test data in the free trade agreement negotiations between EFTA and India. This would entail high compensations to be paid during several years to allow the drug regulation authorities to rely on the test data of the first applicant for the marketing approval of a generic medicine. Access to lifesaving and affordable medicines would thereby be further compromised, as their commercialization would be either delayed or authorized at higher cost.
- Does the Federal council share the concerns expressed by the UN Special Rapporteur on the Right to Health and by UNAIDS (the latter being also supported financially by Switzerland) that – especially in India – an increased protection of test data would undermine access to lifesaving medicines for millions of people, with dramatic consequences for the right to health?
- Indian generic producers provide 80% of the global donor-funded antiretroviral (ARV) medicines for AIDS-treatments in developing countries. 96 out of 100 countries, including the poorest with high HIV-burden, purchase Indian generic ARVs. How does the Federal council ensure that India will continue to play its role of “Pharmacy of the developing world”? How does this reconcile with the claimed protection on test data?
- Western multinationals (and the State Secretariat for Economic Affairs / SECO) refer to article 39.3 of the TRIPS Agreement to justify the need to protect test data against “unfair commercial use”. The relevant WHO Commission CIPIH and Prof. Carlos Correa (Buenos Aires), among others, contest however that this article implies any obligation to confer exclusive rights on test data or any obligation to pay for compensation. So far, no country has ever tried to push this issue through to the WTO Dispute settlement mechanism. What is the position of the Federal council with regard to this legal dispute?
- One Switzerland (SECO) requests through increased data protection a strengthening of intellectual property rights in the health domain. Another Switzerland (Swiss Development Cooperation / SDC) “advocates for the priority of public health matters in debates on intellectual property and in trade considerations” (SDC website). Which one of those applies then?
- In its latest periodic state report review, the UN Committee on Economic, Social and Cultural Rights recommended to Switzerland to undertake an impact assessment to consider the possible negative consequences on access to medicines prior to demanding TRIPS-plus provisions. How does the Federal council intend to implement these recommendations with regards to India?