Access to medicines
[12] It is argued that pharmaceutical companies have dramatically increased prices for treatments that are essential in treating diseases such as HIV/AIDS, hepatitis C, and cancer.
[13] Many argue that generic brand production in developing countries increases competition and therefore is essential to bridge the global drug gap.
[11][9] As argued by various sources, the push for more measures such as market and data exclusivity, hinders low-income countries' ability to manufacture and produce generic drugs.
Developing countries often lack air conditioning, stable electrical power, or refrigerators to store samples and chemicals.
[14] It also argued that international aid, state investment, and measures for infection prevention are necessary to allow for generic brand production in low-income countries.
Under the TRIPS Agreement, WTO member nations, with a few exceptions, are required to adjust their laws to the minimum standards of IPR protection.
A clause in the TRIPS agreement allows compulsory licensing, which permits the manufacture of generic brands of patented drugs, at prices set in a competitive market in cases of national emergencies.
[9] For example, many believe that the HIV/AIDs crisis in Africa and South East Asia and the inadequate access to essential AIDs medications constitute a national emergency.
[18] The Doha Declaration on the TRIPS Agreement and Public Health, effective November 2001, was adopted by WTO Ministerial Conference of 2001.
Many argued that the TRIPS Agreement hindered developing countries from implementing measures to improve access to affordable medicines, especially for diseases of public health concern, such as HIV, tuberculosis, and malaria.
It refers to specific parts of TRIPS, such as the use of compulsory licensing for pharmaceutical drugs only in the case of a national emergency and circumstances of extreme urgency and the right to determine what constitutes this—such as to address public health issues.
[21][22][23] Another mechanism to enable access to essential medicines in low- and middle-income countries (LMICs) is a voluntary license (VL).
[25] A study in The Lancet suggest that voluntary licensing was an effective tool in advancing access to Hepatitis C antiviral medicines.
In compliance to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), India reintroduced patent laws for drugs in 2015.
[11] Civil society organizations in India, led by the Sankalp Rehabilitation Trust, are opposing Gilead Sciences' patent applications for the HIV drug lenacapavir.
[32] Lenacapavir, a twice-yearly injection, has shown strong potential for HIV prevention, offering hope for ending AIDS if widely accessible.
[33] Gilead Sciences has agreed to voluntary licensing deals allowing companies to produce generic versions of its HIV drug, lenacapavir, for 120 low- and lower-middle-income countries.
[34][35] This decision follows clinical trials showing the drug’s effectiveness in preventing HIV, particularly as a twice-yearly injectable, which could address the challenges of daily pill adherence and stigma.
[40] During the 2024 opening of the World Conference on Lung Health in Bali, Indonesia, numerous tuberculosis activists took to the stage to call on Cepheid and its parent company, Danaher, to lower the price of GeneXpert TB diagnostic tests to $5 in low- and middle-income countries.
Lowering the cost of these tests is crucial, as tuberculosis has regained its position as the world’s deadliest infectious disease, surpassing COVID-19.
[42] In 2024, South African regulators have concluded that Vertex Pharmaceuticals has adequately addressed access to its cystic fibrosis treatments, closing a contentious investigation that highlighted the high costs of the company’s medications.
[43] However, this decision has drawn criticism from patient advocacy groups, who argue that the outcome remains unfair and that some individuals with cystic fibrosis.
The case gained international attention when a coalition of families and activists petitioned governments in South Africa, India, Brazil, and Ukraine to allow access to lower-cost generic versions of Trikafta, a highly effective triple-combination therapy.
Over the years, similar advocacy efforts have fueled disputes between the company and financially constrained governments, as patients and their families push for more affordable options.
[47] On June 20, 2024, MSF announced closing down its Access-to-medicines campaign focused on enabling access to medicines in resource limited settings.
