Workshop Highlights IP Hindrances For Avian Flu Drug Stockpiles 14/11/2005 by Tove Iren S. Gerhardsen for Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Panelists at a Geneva workshop on intellectual property issues related to a possible avian influenza pandemic argued that IP rules and prices could make it difficult for nations to prepare sufficient stockpiles. Panelists argued that practical problems could arise with the application of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to preparations for a possible pandemic. The 10 November panel was sponsored by Consumers International and the Consumer Project on Technology (CPTech). Debate centred on a statement read out by the WTO General Council chairman on 30 August 2003 when a temporary waiver to the TRIPS Agreement was adopted, allowing poor countries to import generic drugs produced under compulsory licenses. The waiver was mandated under paragraph six of the 2001 Doha Declaration on TRIPS and Public Health, and WTO negotiators are currently discussing the status of that chairman’s statement as they work to make the waiver permanent. Roger Kampf, counsellor at the WTO intellectual property division, said that the chairman’s statement was “not specifically adding anything new.” CPTech Director James Love contested this, saying that the chairman’s statement seemed stronger than the actual waiver. The chairman’s statement refers to a number of countries who committed to not using the waiver. Love pointed out that many of the developed countries that had opted out of the waiver — saying that they would not import generic medicines produced under compulsory license — would not be able to produce generic Tamiflu (oseltamivir). Tamiflu is marketed by Roche and is believed to be most effective in case of an avian flu pandemic. The chairman’s statement also prevents developing countries from using the waiver as those countries that had opted out had taken the “moral high ground,” Love said. Sisule Musungu of the South Centre said that the fact that the debate was not about whether the system was working but just about the chairman’s statement, “illustrated the lack of seriousness of all countries.” So far no country has used the paragraph six waiver. Love referred to a European Union case from 2000 involving Canada, in which it was stated that Canada was too small in terms of its gross domestic product (GDP) per capita of US$30,711 to have generic producers manufacture on an economic scale, unless they exported. This calls into question the situation for countries such as Latvia ($5,918) or Slovakia ($7,623), which do not have the economy of scale to produce generics themselves but have opted out of the waiver, Love said. Jennifer Brant of Oxfam agreed, saying that it seemed like many developed countries had “shot themselves in the foot” by opting out of the waiver, and that the Tamiflu situation illustrated how “rules had gotten out of control.” Musungu said that it did not seem like countries such as the United States were worried about having opted out of the waiver decision as they believed local production would be the solution. He referred to a US politician saying that in the case of an avian flu pandemic, they would make sure that no products would leave the country. Ellen ‘t Hoen of Médecins Sans Frontières (MSF) said that the paragraph six decision was very difficult to use in practice, and in many ways countries were less well off with the TRIPS agreement as in the past there had been no regulations standing in the way of a country importing generics. As Canada is one of the few nations to have implemented the TRIPS waiver, MSF has tried to use the TRIPS agreement to obtain exports from there to poor countries for the past two years. MSF started right after Canada announced that it wanted to adopt it into national law, but the organisation still has not managed to make use of it because of the complexity of the process, ‘t Hoen said. She said that hopefully, at one time in the future, “a box of drugs would be exported to a country.” Others pointed out that MSF’s problems could be caused by extra demands in the Canadian law. She noted that MSF had placed an order for Tamiflu with Roche earlier this year at EUR15.80 ($18.50) per treatment, but the signal was that it would not get it as the “order book of Roche is full until 2007.” Sangeeta Shashikant of the Third World Network said that many African countries were not even aware of how to issue compulsory licenses. A compulsory license would have to be issued in the exporting country as well as the importing country (if the product is patented), and this could take time, Shashikant said. Moreover, if further supplies were needed, a new license would have to be issued. Canadian law also requires that every party handling the order on the way to the receiver (during transport) has to be identified, causing extra “procedural hazards,” Shashikant said. Test Data Presents Possible Obstacle Test data exclusivity is another potential intellectual property right hurdle which could get in the way of countries trying to use the TRIPS agreement to issue compulsory licenses, said Carsten Fink of the World Bank Institute. A medicine’s test data refers to safety and efficacy studies which provide the basis for a product’s approval. This data is subject to proprietary rights but in many countries generic companies applying for regulatory approval after the patent of the original medicine has expired may refer to the original studies. However, some countries have signed so-called “test data exclusivity” period agreements meaning that the data (originator dossier) may not be used for, say, five years, and regulators “cannot approve based on previous tests,” Fink said. The United States has signed bilateral trade agreements with such provisions with a number of countries, he said. This means that in some countries where a medicine is not even patented, generic companies will have to wait until the end of the data exclusivity period to have their products approved. For generic companies it is costly and unethical to carry out new tests, Ross Duncan of the World Health Organisation said. Fink said that the test data exclusivity periods are legally a different instrument and often used as “protection against compulsory licenses,” adding, however, that TRIPS says nothing about test data. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related "Workshop Highlights IP Hindrances For Avian Flu Drug Stockpiles" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.