Access to medicines

Hindrances to access

Most obstacles to access stem from market competition or its absence. Patents grant an owner exclusive rights to a product or process for 20 years in a given territory, allowing the patent holder to prevent manufacture, use, sale, import, or distribution. This protection is argued to give pharmaceutical companies a monopoly on particular drugs. Data exclusivity is a regulatory measure that temporarily restricts the use of clinical trial data, giving the trial conductor exclusive rights.

Critics contend that extending exclusivity periods reduces the availability of generic drugs, especially in developing countries, while proponents note that extended patent terms can fund research and development or support drug donations. In some nations, pharmaceutical companies control the pricing of their patented products, setting prices based on manufacturing costs and desired profit, with purchasers having little influence. Price gouging—the excessive increase in prices of essential goods—is argued to leave buyers vulnerable and create inequitable access across socioeconomic groups, particularly for treatments for HIV/AIDS, hepatitis C, and cancer.

Legislation

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), effective January 1995, is a multilateral agreement among all WTO member nations that introduced global standards for enforcing and protecting intellectual property rights, including patents and data protection. Member nations must adjust their laws to minimum IPR standards and follow enforcement guidelines and dispute resolution procedures. TRIPS is argued to have significantly affected the pharmaceutical industry and access to medicines, negatively impacting generic drug industries in countries like India.

However, the agreement includes a clause allowing compulsory licensing, which permits generic manufacture of patented drugs at competitive prices during national emergencies. The HIV/AIDS crisis in Africa and Southeast Asia, with inadequate access to essential medications, has been cited as such an emergency.

Epidemics and access

Generic manufacturers in low-income countries such as India and Brazil were key to expanding HIV/AIDS treatment access in low- and middle-income countries. Competition from generics reduced first-line antiretroviral drug prices by over 99%, from $10,000 per patient per year in 2000 to less than $70 in 2014. Civil society organizations in India, led by the Sankalp Rehabilitation Trust, are opposing Gilead Sciences' patent applications for the HIV drug lenacapavir, arguing that generic competition is essential for affordability in middle-income countries.

Gilead Sciences has agreed to voluntary licensing deals allowing generic production of lenacapavir for 120 low- and lower-middle-income countries. In 2015, Turing Pharmaceuticals raised the price of Daraprim, an essential anti-parasitic drug for HIV treatments, from $13.50 to $750 per tablet. Johnson & Johnson announced in 2023 it would not enforce its patents on bedaquiline for multidrug-resistant TB in 134 LMIC countries and granted a license for generic supply.

Campaigns

Several countries and organizations have initiatives to improve access to medicines. Canada's Access to Medicines Regime allows developing countries to obtain lower-cost medicines and permits Canadian companies without ownership rights to manufacture medications for export to certain developing nations. Médecins Sans Frontières ran the Campaign for Access to Essential Medicines from 1999 until June 20, 2024, when it announced closing the campaign to focus on products needed for its own relief efforts, a move criticized by some advocates including the Treatment Action Group.

In Tanzania, the Ministry of Health, the Tanzania Food and Drugs Authority, and the Strategies for Enhancing Access to Medicines Program, with aid from the Bill & Melinda Gates Foundation, introduced accredited drug dispensing outlets to create a nationwide chain providing quality pharmaceutical drugs and services. The GAVI vaccination alliance, an international public-private partnership founded in 2000, works to improve vaccine access in low-income countries, partnering with developing nations, donor governments, research agencies, vaccine companies, and organizations including WHO, UNICEF, the World Bank, and the Bill & Melinda Gates Foundation.

Did You Know?

• In low-income countries, more than 90% of deaths from pneumococcal disease, 95% from Hib, and 80% from hepatitis B occur.
• The human papillomavirus (HPV) vaccine is considered the most expensive vaccine in history, yet the majority of cervical cancer cases are in developing countries.
• In the mid-1990s, Brazil began manufacturing generic versions of vital AIDS medication, leading to a decline in AIDS mortality of almost 50%.