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Info Service on Health Issues (Feb25/08) Penang, 20 Feb (Kanaga Raja) — The first batch of a generic version of dolutegravir (DTG), a key antiretroviral drug used in the treatment of HIV, has arrived in Colombia under a compulsory license (CL) issued by the country, the Make Medicines Affordable (MMA) campaign reported on 19 February. In a post on its website, the MMA campaign, which is led by the International Treatment Preparedness Coalition (ITPC) and partners, said that this marks a significant milestone for the Colombian government in prioritizing patients over the profits of pharmaceutical companies. Through the CL, the price of DTG was reduced from almost US$100 to US$3 for 30 tablets, the equivalent of a monthly course of HIV treatment, which should be taken by a person living with HIV during their whole life, it said. In what was widely viewed as a “landmark move”, the government of Colombia on 24 April 2024 issued its first- ever CL aimed at enabling access to less-expensive generic versions of the key HIV drug DTG, which now has the potential to treat 28 people for the price of treating just one. (See SUNS #9997 dated 2 May 2024). The World Health Organization (WHO) recommends dolutegravir as the first- and second-line treatment for all population groups. MMA said that in Colombia, access to this medication was delayed or limited due to the patent holder, namely British pharmaceutical company ViiV Healthcare, imposing extremely high prices that left the drug out of the reach of patients in Colombia. (The company was created as a joint venture by GSK and Pfizer in November 2009, joined by Shionogi in 2012. As of December 2023, 76.5% of the company is owned by GSK, 13.5% by Pfizer and 10% by Shionogi.) According to MMA, the Latin American Network for Access to Medicines (RedLAM) reports that a comparative price study revealed very high costs of dolutegravir in Colombia due to a patent-created monopoly. To counteract this, the government of Colombia issued a CL in April 2024, MMA reported. Incidentally, also in April 2024, Colombia had tabled a proposal (IP/C/W/712) at the World Trade Organization on the review of the implementation of the TRIPS Agreement, as mandated by its Article 71. In its proposal, Colombia said that a comprehensive review of the implementation of the Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) is both “an unfulfilled commitment and a necessity.” Colombia said carrying out the review mandated in Article 71, along with the 30th anniversary of the TRIPS Agreement, will provide an opportunity to: (i) increase dialogue and transparency on the impact of international rules on Intellectual Property (IP) issues; (ii) start overcoming the existing impasse of the TRIPS discussions and negotiations at the TRIPS Council; (iii) support political and technical discussions that are taking place in other forums and settings; and (iv) identify/produce relevant metrics to inform better implementation in the future. Colombia said that it aims to engage in collaborative discussions at the WTO to identify (or produce) relevant analytical metrics and data, “which are currently non-existent, incomplete, or not appropriately used, to better assess the implementation of the TRIPS Agreement over the years, and better guide the discussions and domestic policymaking process of Members.” These new metrics could become part of a permanent source of information at the TRIPS Council, at Trade Policy Reviews of individual Members, or at the Trade Monitoring exercise by the Secretariat, among others, it added. To attain these objectives, Colombia proposed to address discussions on the following implementation aspects: a. To analyse both domestic and international concentration of production in knowledge-intensive sectors over the years, based on relevant metrics. b. A global stocktake on royalties paid in and out by country for the use of Intellectual Property Rights, as expressed in the Balance of Payments of countries. c. A global stocktake on the use of Compulsory Licences since 1996, with a focus on the problem of export limitations faced by “sandwich” countries (not too small, not too large). d. A global stocktake on the residency/nationality of innovators across Members, coupled with an examination of Patenting activity by Office of Subsequent Filing – OSF – (to better understand who is patenting internationally and domestically, and the incentive mechanisms that exist for innovators to go abroad). e. A related discussion on the exploitation of “disclosures” after IPRs (intellectual property rights) finish their terms of protection. As an implementation matter, are these innovations/creations publicly available? Are they used by Members (especially developing ones)? Are they available for training of artificial intelligence models? (optional trigger questions). f. The utilization of Article 44(2) of TRIPS by WTO Members. At a WTO TRIPS Council meeting on 26 April 2024, the Colombian proposal, which was supported by many developing countries, was resisted by the pharmaceutical-producing nations such as Switzerland (see SUNS #9997 dated 2 May 2024). The review of the implementation of the TRIPS Agreement is expected to take place in the TRIPS Council sometime this year. Reporting on the arrival of the first batch of the HIV drug DTG in Colombia, MMA said Colombian President Gustavo Petro announced the shipment on the social media site X, with a photo of the first shipment, containing 300,000 doses of DTG. MMA quoted President Petro as saying: “It [dolutegravir] was very expensive in the market… The EPS [public health insurance system] did not prescribe it due to its price, and many people died of AIDS, which was avoidable.” “Now, thanks to the progressive Ministry of Health, it comes at such a low price that we are ready to reduce the disease as much as possible,” said President Petro. As reported by MMA, granting compulsory licensing to this and other medications is an important step towards reducing prices and making treatment more accessible. It will also increase the number of people who can access DTG. MMA quoted Juliana Lopez from iFarma in Colombia as saying: “We appreciate the efforts of the national government, as well as of so many people and organizations in Colombia, the region, and the world, who have worked tirelessly to make the use of public health safeguard contemplated in international intellectual property regulations a reality.” “This progress allows Colombia to optimize the use of public resources in health and respond more effectively to the prevalence and incidence of HIV,” Lopez added. ADVOCACY IN BRAZIL Last year, the MMA campaign had reported that the Brazilian Interdisciplinary AIDS Association (ABIA), an advocacy group in Rio de Janeiro and a partner of the MMA campaign, had called on the Ministry of Health to issue a CL for DTG. MMA had quoted Susana van der Ploeg, the coordinator of the Working Group on Intellectual Property, and project assistant at ABIA as saying: “What we are seeing here in Brazil is an abuse of the patent system and a high price for DTG.” “We believe that to combat the abusive pricing, the Ministry of Health should issue a compulsory license for DTG,” she added. According to the MMA campaign, affordable antiretrovirals are essential for Brazil, which has the highest HIV prevalence in Latin America – nearly a million people are living with HIV – and a steadily rising rate of new HIV infections, which reached 51,000 in 2022. It said currently, Brazil spends nearly two-thirds of its HIV budget on treatment, leaving prevention and testing programs underfunded. MMA said today, a single tablet in Brazil costs R$4.40 (about US$0.80), when it could be 0.70 cents. In 2023, the government purchased 180 million units of DTG at a price of R$4.40. DTG was patented by ViiV Healthcare, which initially priced the drug at US$3,606 per person, per year in Brazil. MMA said as a result of ABIA’s efforts, the government changed its treatment guidelines to include DTG as part of first-line treatment, thus increasing demand for the drug. The government also negotiated a 75% price reduction with ViiV Healthcare (from US$3,606 to US$558 per person, per year), said MMA. +
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