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TWN
Info Service on Health Issues (Nov25/05) UNGA draft resolution on rare diseases silent on IP barriers and TRIPS flexibilities New Delhi, 27 November (K.M. Gopakumar) – A draft United Nations General Assembly resolution on rare diseases is silent on the intellectual property barriers to access to treatment and the use of TRIPS flexibilities to overcome such barriers. The revised draft resolution dated 7 November is co-sponsored by Armenia, Austria, Bosnia and Herzegovina, Brazil, Cyprus, Germany, Honduras, Kuwait, Lebanon, Lesotho, Luxembourg, Malta, Oman, Philippines, Poland, Portugal, Qatar, Spain, Viet Nam and Yemen. This would be the third UNGA resolution on rare diseases since 2021. The second resolution was adopted in 2023. None of these resolutions contains any operational paragraph regarding the use of TRIPS flexibilities. This is a departure from other UNGA resolutions on various health issues such as HIV/AIDS, non-communicable diseases and universal health coverage. The preamble of the current draft resolution recognizes there are barriers to affordable access, stating: “… Reaffirming the right of every human being, without distinction of any kind, to the enjoyment of the highest attainable standard of physical and mental health … and to the continuous improvement of living conditions, with particular attention to the alarming situation of millions of people for whom access to healthcare services and medicines remains a distant goal, owing to a number of different barriers, such as inequitable access, high prices and financial hardship, in particular people who are in vulnerable situations, including those in developing countries….” However, there is no elaboration of the reasons behind “inequitable access, high prices and financial hardship”. One important reason for the inequitable access and financial hardship is the exorbitant prices of medicines and therapies available for rare diseases due to patent and trade secret protection. As reported earlier by the Third World Network, affordable access is a major concern in the context of rare diseases. Relevant parts of that report showing the high cost of many rare disease medicines and therapies are reproduced below: “In 2024, of the 50 novel drugs approved by the USFDA [US Food and Drug Administration], 26 … or 52% … were for rare diseases. While the benefits of these newer drugs and therapies are remarkable, their high prices render them inaccessible outside high-income countries. Despite the increase in approvals for drugs for rare diseases, innovation is not translating to accessibility, especially for developing countries as all such new drugs are being commercialized almost exclusively in high-income countries, with prices set as high as USD 4.25 million per patient (for a rare disease metachromatic leukodystrophy, or MLD). “The table below displays the exorbitant cost associated with several newly approved medicines and treatments for rare diseases:
“The high price of medicines for rare diseases is a major concern at a time when national governments face economic difficulties, and budget‐constrained healthcare systems find it difficult to meet the escalating demand for treatments.” Use of TRIPS flexibilities Flexibilities allowed under the World Trade Organization (WTO)’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) can significantly facilitate the availability of affordable medicines for rare diseases. Two recent developments clearly demonstrate their utility. On 17 October, India’s Supreme Court rejected the transnational pharmaceutical firm Roche’s appeal seeking a stay of a Delhi High Court order which had upheld a lower court's decision denying Roche a preliminary injunction to prevent generic manufacturers from producing and marketing risdiplam, a treatment for spinal muscular atrophy. Roche's patent monopoly allowed it to charge approximately USD 7,500 per bottle, with adults requiring three bottles monthly – totalling roughly USD 22,500 per month. The Supreme Court's judgment enabled generic production at prices 98% cheaper than Roche's. This outcome was made possible by TRIPS flexibilities incorporated into India's Patents Act, particularly safeguards against evergreening patents and Bolar provisions which permitted generic manufacturers to develop alternatives before patent expiration. In a separate development, Beximco, a Bangladeshi pharmaceutical company, announced the generic production of a triple combination therapy for treating cystic fibrosis. The originator company, Vertex, charged USD 320,000 per person annually. However, Bangladesh's status as a least developed country (LDC) exempts it under the TRIPS Agreement from providing product patent protection, thereby enabling generic production at USD 12,775 annually for adults and USD 6,387.50 for children – 96% cheaper than Vertex's price. Notably, although Vertex obtained patents in countries with generic production capabilities, such as India, it strategically avoided seeking marketing approval there. This demonstrates how patents can be misused to prevent generic competition rather than serve their intended purpose of promoting innovation. Silence on critical gap in affordable access Out of 20 proposed operative paragraphs (OP) in the draft UNGA resolution, three directly deal with the treatment of rare diseases, i.e., paragraphs 1, 13 and 19. OP 1: Calls upon Member States to strengthen health systems and referral systems between primary health care and other levels of care, in order to provide universal access to a wide range of healthcare services that are safe, of quality, accessible, available and affordable, timely, clinically and financially integrated, and gender-responsive, with full respect for human rights, which will help to empower persons living with a rare disease, whether genetic or acquired, including those with rare infections and rare allergic conditions, as well as those with an undiagnosed rare disease, in addressing their physical and mental health needs to realize their human rights, including their right to the highest attainable standard of physical and mental health, to enhance health equity and equality, end discrimination and stigma, eliminate gaps in coverage and create a more inclusive society; OP 13: Calls upon Member States to accelerate efforts towards the achievement of universal health coverage by 2030 to ensure healthy lives and promote well-being for all persons, including those persons living with a rare disease, as well as those with an undiagnosed rare disease, all throughout the life course, and in this regard re-emphasizes the resolve: (a) To progressively cover persons living with a rare disease, and those with an undiagnosed rare disease, with quality essential health products, health services, including adequate preventive measures such as newborn screening, and quality, safe, effective, affordable and essential medicines and therapies, diagnostics, with the particular aim of shortening and easing the pathway to a diagnosis and treatment for persons living with a rare disease, health technologies, and strengthened primary healthcare, referral pathways, multidisciplinary care coordination plans, increased registration efforts, and access to specialized care, with a view to completely covering all persons living with a rare disease by 2030; (b) To reverse the trend of catastrophic out-of-pocket health expenditure, which carries psychosocial and economic consequences for both persons living with a rare disease and their families, by providing measures to ensure financial risk protection and eliminate impoverishment due to health-related expenses by 2030, with special emphasis on persons living with a rare disease; OP 19: Invites Member States to continue to consider, at future sessions of the General Assembly, addressing the multidimensional challenges faced by persons living with a rare disease, including with respect to access to quality, safe, effective and affordable diagnostics and therapies, as well as the challenges faced by their families and caregivers, while identifying possible implementation gaps in the protection of the human rights of persons living with a rare disease, including options for the elaboration of an agreement, guidelines, an international convention or other international standards; OP 1 calls for strengthening health systems and referral mechanisms to ensure universal access to a comprehensive range of healthcare services that are safe, of high quality, accessible, available and affordable. OP 13(a) and OP 19 both reference access to affordable diagnostics, medicines and therapies. However, they diverge in language and scope. OP 13(a) specifically uses the term "essential medicines and therapies", while OP 19 omits the word "medicines" and refers only to "therapies". OP 19 calls for future sessions to address various issues related to rare diseases, including access to quality, safe, effective, and affordable diagnostics and therapies. The draft resolution notably omits any discussion of a critical barrier to rare disease treatment: lack of availability of affordable medicines and therapies stemming primarily from patent and trade secret protections. This silence on intellectual property barriers creates a significant problem – it allows transnational pharmaceutical corporations to avoid scrutiny while shifting responsibility to governments, particularly those in developing countries, for the unavailability of affordable medicines and therapies for people living with rare diseases.
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