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Info Service on Intellectual Property Issues (May24/02) The compulsory licence (CL) was issued on 24 April for use by Colombia’s Ministry of Health, which allows improved access to the generic versions of dolutegravir. Such a licence is a flexibility under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and does not require permission from the patent owner ViiV Healthcare (a joint venture of GlaxoSmithKline, Pfizer and Shionogi). Medecins Sans Frontieres (MSF), together with Public Citizen and Global Humanitarian Progress Corporation Colombia, welcomed the decision by the Colombian government. In a press release issued on 24 April, MSF said that this “landmark move” by the Colombian government is an encouraging example for countries in the region and beyond, on how a CL works in practice to improve access to medicines. “Colombia’s decision to issue a compulsory license for dolutegravir is great news because, until now, we have not been able to introduce dolutegravir in our medical operations, as the costs have been prohibitive,” said Dr Carmenza Galvez, medical coordinator for MSF in Colombia and Panama. “We therefore very much welcome today’s decision and news of the more affordable generic price, as this will facilitate the use of dolutegravir in our first-line treatment of HIV for the survivors of sexual violence whom we serve in our medical operations in Colombia, and it will allow more and more people living with HIV in Colombia to access the most effective medicine.” “The licensing of dolutegravir in Colombia will prevent HIV transmission, reach migrants who need treatment, support the financial sustainability of Colombia’s health system, and promote equity and human rights of people living with HIV,” said Luz Marina Umbasia Bernal, director of Global Humanitarian Progress Corporation Colombia. “At the regional level, implementing this mechanism generates a vital precedent for promoting access to essential medicines,” Bernal added. “It is necessary to move towards the elimination of HIV as a public health problem worldwide and contribute to compliance with the Sustainable Development Goals (SDGs). Latin American governments have the right to use TRIPS flexibilities to protect the health of their citizens,” said Bernal. “Colombia is planting a flag for global health equity. This will inspire new regional challenges to patent barriers and improve treatment access, towards an AIDS-free generation,” said Peter Maybarduk, Access to Medicines program director at Public Citizen. “Treatment activists have worked toward this decision for several years, helping Colombia stand up to pharma. Where global solutions fall short, countries can and must take control to secure access to medicines for all,” he added. The World Health Organization (WHO) has since 2019 recommended dolutegravir as part of the preferred first- line treatment regimen for people living with HIV for all population groups. MSF said it uses a dolutegravir-based first-line HIV treatment regimen across its HIV/AIDS programmes, and has seen patients benefit from the fewer side effects the drug causes and a lower risk of developing resistance. However, in many countries where MSF works, access to more affordable generic versions of dolutegravir remains a challenge, it added. In Colombia, due to patent barriers and high prices, MSF has not yet been able to introduce dolutegravir in its medical programmes. It said that although generic versions of dolutegravir are available internationally for a fraction of ViiV’s price through voluntary licenses with the Medicines Patent Pool (MPP) (in 2014), ViiV excluded Colombia and many middle-income countries from being able to benefit from its license with MPP, allowing ViiV to maintain its monopoly and continue to charge high prices in Colombia and other countries excluded from the license. According to the Colombian government, the estimated cost of treatment of dolutegravir, as sold by ViiV under the brand name Tivicay, was approximately US$1,224 per patient per year in 2023 in Colombia. MSF said this is an exorbitant mark-up when compared to the US$22.80 or US$44 per patient per year price of generic dolutegravir offered in 2023 through the Global Fund and Pan-American Health Organization (PAHO), respectively, and from which Colombia, however, could not procure. The price available to the Ministry of Health under today’s CL (US$44 per patient per year) is therefore a huge step towards enabling affordable access to more affordable generic versions of dolutegravir for all people who need it, including by opening the door for MSF to introduce dolutegravir in its medical programmes, it said. In contrast, a separate voluntary licence with MPP was granted by ViiV for generic versions of dolutegravir for Azerbaijan, Belarus, Kazakhstan and Malaysia in November 2020 following several years of advocacy by patient groups and health activists who criticised the exclusion of so-called upper-middle-income countries from the first round of voluntary licencing. However, ViiV imposed undisclosed royalty rates that are much higher for the four countries. Malaysia’s Ministry of Health, which provides free HIV treatment, still cannot afford to include dolutegravir for first-line treatment. IN THE PUBLIC INTEREST Meanwhile, back in October 2023, the Joint United Nations Programme on HIV/AIDS (UNAIDS) had applauded the government of Colombia for declaring the HIV medicine dolutegravir of public interest. It said this important breakthrough in public health measures will allow the government to issue a compulsory license, breaking the monopoly, and making it much more affordable for the Colombian government to purchase or manufacture. In a press statement issued at that time, UNAIDS said that the new decision could mean that the price of the life- saving medicine is reduced by as much as 80%. “When the power to produce health technologies is held by a few companies, the result all too often is that countries can’t afford the high prices and people who need newer products cannot access them,” said Luisa Cabal, UNAIDS Regional Director for Latin America and the Caribbean, in the press statement. “We are confident that this decision will have an impact across the whole region and beyond, as many middle- income countries are struggling to access generic markets of key health products to prevent and treat HIV infection,” she added. According to UNAIDS, as well as being effective, treatments incorporating dolutegravir-based regimens have demonstrated greater adherence, due to fewer side effects, while presenting enhanced safety, and reduced likelihood of drug resistance. “This decision represents a milestone for public health in Colombia. Since the Ministry of Health initiated the administrative procedures earlier this year, over 120 civil society organizations, other government agencies, academia and international organizations including UNAIDS supported this process,” Andrea Boccardi Vidarte, UNAIDS Director for the Andean Countries, said in the press statement. “Through our local, regional and global offices, UNAIDS will continue supporting the government on the implementation of this landmark decision,” Vidarte underlined. According to UNAIDS, with this decision, the Colombian government estimates that it will be able to put 28 people on dolutegravir for the same price that it is allocated today to treat just one person. It noted that the country hosts the largest number of Venezuelan migrants in the world (2.9 million as of October 2022). Recent studies have shown a 0.9% HIV prevalence among this migrant population, almost double the 0.5% HIV prevalence among the country’s adult population. “This decision provides the government with the legal conditions to manufacture or purchase more affordable versions of this essential first-line antiretroviral treatment for all people living with HIV in Colombia, including Venezuelan migrants,” said Cabal. SPECIAL 301 REPORT Meanwhile, in a separate press release issued on 25 April, Public Citizen drew attention to the annual Special 301 Report released by the US Trade Representative, Ambassador Katherine Tai, which criticizes countries’ intellectual property practices and establishes US positions on global controversies such as patents and access to medicines, including “TRIPS flexibilities” under WTO rules. However, Public Citizen pointed to an apparent shift in position this year, with the USTR stating its “policy of declining to call out countries for exercising TRIPS flexibilities, including with respect to compulsory licenses, in a manner consistent with TRIPS obligations.” In a statement, Peter Maybarduk, Public Citizen’s Access to Medicines program director, said: “President Biden has introduced measures to make medicines more affordable for Americans, including patented medicines. Now USTR, in an important evolution, is stating that it will not criticize other countries’ efforts to do the same, at least as regards compulsory licensing.” “Historically, the US government has sided with Big Pharma at the expense of access to medicines and vaccines in developing countries, contributing to suffering and preventable death during the early global AIDS crisis and accepting access delays at the height of the Covid emergency.” “Today’s statement gives reason for hope. Countries struggling under the burden of high-priced medicine monopolies should know that the United States will not interfere with their efforts to make medicine affordable for their people, consonant with WTO rules,” he added. “For example, Colombia yesterday [24 April] issued a compulsory license that attends to the needs of people living with HIV by allowing the country to purchase affordable generic drugs from the Pan American Health Organization, instead of relying solely on the expensive patented drug. Colombia’s license will reach migrants who need treatment and support the financial sustainability of Colombia’s health system while promoting equity,” said Maybarduk. “In years past, the US government sought to deter even consideration of such pro-health patent policies, in Colombia and many other countries, under potential penalty of trade sanctions, and provided cover for far more aggressive opposition tactics by powerful prescription drug corporations.” “Now, developing countries pursuing the access to medicine policies that are best for their people need not fear US reprisal,” Maybarduk added. [The Special 301 Report is annually issued by the USTR under Section 301 of the Trade Act of 1974; the provisions of this US law that authorises unilateral “investigation” of industry complaints, and sanctions against targeted countries contravenes WTO rules and has been widely criticised for a long time. [Use of TRIPS flexibilities by WTO Members, especially developing countries, has landed them in the annual Special 301 “watch list”, often creating a chill on legitimate actions to overcome patent barriers for public health purposes.] “This progress is constrained by the still-onerous and pharma-authored rules of the World Trade Organization,” Maybarduk said. +
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