By Tove Iren S. Gerhardsen
Participants at a recent United Nations seminar on developing country production of essential medicines agreed that such a scenario should be possible but they disagreed on the means to get there.
While there was disagreement about the practicalities of certain intellectual property-related regulations (such as when and who should use compulsory licences), there was general agreement that political will, industry participation and the ability for civil society to exert pressure are necessary to enable the use of available regulations intended to increase access to medicines in least developed and developing countries.
“The political will of governments as well as the private sector is essential to determining whether or not matters are effectively addressed,” said Frederick Abbott, international law professor at the Florida State University College of Law. “If the government and its private sector are not committed, very little may be possible.”
Jonathan Berger of the AIDS Law Project in South Africa also emphasised the need for “political space” in terms of laws and freedom of speech to promote access to medicines.
The 19-20 October “brainstorming seminar” was held by the United Nations Conference on Trade and Development (UNCTAD). The event was part of its newly established technical assistance programme on medicine production and access in Africa, in particular Botswana, Ethiopia, Kenya and Tanzania, UNCTAD said.
Most of the IP policy discussed was related to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). One participant asked why no government has used the option to issue compulsory licenses for production of medicines at home or for export to countries without adequate production facilities. This relates to paragraph six of the TRIPS agreement, which was amended in December 2005 to allow exports under compulsory license (IPW, WTO/TRIPS, 6 December 2005).
Franck Schmiedchen of the German Federal Ministry of Economic Cooperation and Development said that India was the key to why this had not been used, as before 2005 India did not have patents on medicines and therefore was able to export to other developing countries. But he suggested this may change now.
Abbott said that the paragraph six solution was “not as brilliant as could have been.” Sergio Balibrea of the European Commission said that we are “still in the testing mode” after the TRIPS flexibilities were put in place, and suggested that it would be better to try out those that are in place before putting in place new mechanisms.
Both Carsten Fink of the World Bank Institute and Kathy-Ann Brown, legal adviser of the Commonwealth secretariat, said that self-reliance and drug production capabilities would be best for developing countries. “Access to medicines is not the same as access to cars,” said Brown, as it is a critical need.
Fink illustrated this with an example of an economics professor walking down the street with a student who sees a $100 bill and wants to pick it up. But the professor says no, it is fake, because if not, somebody already would have picked it up.
Fink suggested focusing on market failures and carefully thinking of what barriers may exist to developing local industries when considering establishing a pharmaceutical industry in a certain country.
Regine Qualmann, head of the trade programme at the non-governmental GTZ, a German development cooperation agency, asked why the market is not supplied if one assumes that there is a market.
Schmiedchen said that to solve the market failure, we “have to do it together with industry,” saying that the failure over the past years had been to try to limit industry.
Schmiedchen talked about Tanzania, Congo, Rwanda, Kenya, Syria, Ethiopia, Bangladesh and Uganda where the German development ministry is helping out with establishing local production through “concrete financial and technical assistance, political collaboration and networking activities,” and Jerome Reichman, professor of law at Duke University (US), referred to Ethiopia, where local production is working.
Reichman favoured creating generic industries in Africa as was done in India before 2006 because one cannot have “public health supply depend on other countries,” and once this production would get going in Africa, there would “spill-over effects” and benefit developed countries as well. He talked about developed and developing country collaboration that would help fulfil TRIPS Article 66.2, which requires developed countries to provide incentives to their private sector to transfer technology to least developed countries.
Roger Kampf of the WTO said that there has not really been any dialogue in the TRIPS Council as to what role technology transfer can play, what it is and what the incentives are, and said it would be useful to have some concrete technology transfer examples.
Reichman called for regional collaboration, but this was questioned by Brown and Qualmann saying it would be difficult to define the regions. Eric Noehrenberg of the International Federation of Pharmaceutical Manufacturers and Associations said that regional projects in Latin America had not worked, and referred to Brazil, which does not have the capacity to supply all of Latin America, he said.
Sangeeta Shashikant of the Third World Network said that compulsory licenses have been issued in India, Ghana and Zimbabwe and “the trend is picking up.” She said voluntary licenses would not be used unless there is pressure.
Berger agreed, saying that voluntary licenses were not granted in a vacuum without civil society pressure. He said there have been only three applications for compulsory license in South Africa and none of them have been granted for medicines. This, Berger said, “seems to be quite a difficult route to take.”
Noehrenberg said that in terms of local production, the best option would be off-patent medicines first, and if that was not an option, consider voluntary licenses. Only after these options have been considered, should one think of compulsory license, he said.
Pascale Boulet of Médicins Sans Frontières provided a number of specific examples of how intellectual property can limit access to specific drugs, such as combination drugs or drugs which are possible to store at high temperatures, but which are “not available to a single developing country.”
Boulet also pointed to the fact that the active pharmaceutical ingredients from which medicines are made are almost exclusively produced in China and India. She also suggested that the incentive mechanisms for producing medicines for neglected diseases should change and alternatives to the patent system should be considered, especially as India and China were tending to produce for the lucrative developed country market.
Jan Gajowski, project manager of the energy and cleaner production branch of the UN Industrial Development Organization, said that one anti-malaria drug based on wheat growing in developing countries is sold to developed countries where companies add value and sell it back. This “should not be so,” and “should be done also in developing countries,” he said.
Berger talked about licenses and competition rules. He warned that while it is currently unlawful in the European Union for a company to refuse to grant a license when it prevents market entry of innovative products, the EU position seems to be leaning toward the US position, which is that companies have the freedom to choose whether to license a product.
Tove Iren S. Gerhardsen may be reached at tgerhardsen@ip-watch.ch.