Compulsory licences for direct-acting antiviral drugs for hepatitis C
Unlike England, Italy does not have a NICE. The decision to ration treatment with the new direct-acting drugs against hepatitis C virus was taken behind closed doors by our Ministry of Health. No need to go through all the troubles well described by Gornall et al in their article.1 In Italy, a 12-week course of treatment with sofosbuvir costs 41,000 euros and the Ministry of Health has so far given permission for 55,000 treatments, about 5% of the estimated need. The explicit reason for this rationing decision is that universal access to treatment may jeopardize the sustainability of our NHS.
Several proposals have been made so far to overcome this problem and increase access to treatment. An economist in the UK thinks that governments should retain the lion’s share of intellectual property rights and limit patents.2 In the US, a “government patent use” law could be applied that would allow patients in federal programmes to be treated with inexpensive generic medicines.3 We think, however, that the adoption by governments of a compulsory license would radically solve the problem and would also deter other companies from playing financial games, as Gilead did with sofosbuvir.4
Compulsory licenses are possible under articles 27 and 31 of the TRIPs (Trade Related Aspects of Intellectual Property rights) in case of national emergencies.5 Several sources, from the US to China to the World Health Organization, affirm that the burden of death and disease associated with HCV is a national and global priority, and the World Health Assembly has recently deliberated a global strategy aimed at the elimination of hepatitis, as a major public health threat, by 2030.6 The Doha Declaration, adopted by the World Trade Organization in 2001, confirmed in paragraphs 5 that “each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted”.7 Compulsory licenses have already been adopted by many low and middle income countries, but there are examples of similar rulings also from high income countries, including Italy.8
Based on the above considerations, we drafted a petition that has been posted in a popular Italian website on international health,9 and that has so far been undersigned by a large number of individuals and organisations.10 Among them, some members of the Italian parliament, representatives of medical colleges and associations, many grassroots associations, and several academics and researchers. The search for signatures will continue, the plan being that by the end of September 2016 the petition will be delivered to the Italian Ministry of Health.
We know that our petition is, politically speaking, a hot potato, very unlikely to be handled and accepted by the Italian government, especially if this is left alone by other countries in the European Union (EU). The chances of success would be higher if similar petitions were submitted to the attention of other EU governments by their respective citizens. Representatives of the health professions should lead such a movement, if they firmly believe that access to medicines is a right that should not be denied in favour of free market.
1. Gornall J, Hoey A, Ozieranski P. A pill too hard to swallow: how the NHS is limiting access to high priced drugs. BMJ 2016;354:i4117
2. Mazzucato M. High cost of new drugs. BMJ 2016;354:i4136
3. Kapczynski A, Kesselheim AS. “Government patent use”: a legal approach to reducing drug spending. Health Affairs 2016;35(5):791-7
4. Roy V, King L. Betting on hepatitis C: how financial speculation in drug development influences access to medicines. BMJ 2016;354:i3718
5. World Trade Organization. Agreement on Trade-Related Aspects of Intellectual Property Rights. Marrakesh, Morocco, 15 April 1994 https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
6. Hepatitis C: global ambition, national realities. The Lancet 2016;387:1970
7. World Trade Organization. Declaration on the TRIPS agreement and public health. Doha, Qatar, 14 November 2001 https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
8. Reichman JH. Compulsory licensing of patented pharmaceutical inventions: evaluating the options. J Law Med Ethics 2009;37:247-63
9. Epatite C. Il diritto alla cura. 20 July 2016 http://www.saluteinternazionale.info/2016/07/epatite-c-il-diritto-alla-c...
10. Big Pharma. Una storia che si ripete. 25 July 2016 http://www.saluteinternazionale.info/2016/07/big-pharma-una-storia-che-s...
Competing interests: No competing interests