Licensing for equity: Why access to medicines needs a new global approach A ccess to medicines in low- and middle-income countries has always been an issue but deaths from AIDS catapulted it into the global consciousness. The Covid-19 pandemic As the world prepares for future pandemics and tackles non-communicable diseases, the voluntary licensing model must evolve to serve a broader range of health challenges and ensure access is equitable
voluntary licensing has become widely accepted as an access strategy for infectious diseases, it has not for non-communicable diseases: more than 50 billion doses of infectious disease medicines have been manufactured and delivered under licences from MPP, while few have for NCDs. This is due to less advocacy for NCDs, an apparent split in how pharmaceutical companies think about infectious and non-communicable disease medicines, as well as a lack of precedent for the model, availability and affordability, the complexity of the new NCD drugs, and, since 2020 an extremely volatile public health environment. A PROVEN MODEL Indeed, given today’s pricing and tariff pressures, the pharmaceutical industry may be more concerned with income than access. It is therefore necessary to show that access and income are not mutually exclusive. In upper-middle-income countries, where originator companies have been unable to sell significant volumes at their lowest acceptable price, fixed royalties can provide a commercially attractive solution. At the same time, affordable prices are viable for governments, enabling them to purchase large quantities. The 2020 MPP agreement with ViiV Healthcare is a fine example of a win-win-win solution, because, most importantly, people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia now have access to the best HIV treatment available. The size of royalties can financially incentivise pharmaceutical companies; so too does the timing. There is a long lag between when essential medicines are launched in the US and when they are launched in LMICs – an average of 4.5 years
reinforced the pressing need for access to health products in LMICs, especially in Africa, and the consequences of its lack. Some pharmaceutical companies have tried different approaches to access: donations, tiered pricing, second brand, direct bilateral licensing and non-exclusive voluntary licensing. All have their pros and cons. One advantage of licensing to multiple generic manufacturers, through mechanisms such as the Medicines Patent Pool, is creating competition among the manufacturers, typically driving down prices. Seeing the value of non-exclusive voluntary licensing, especially if the goal is to improve public health, Unitaid established MPP in 2010, to address inadequate access to affordable HIV medicines in LMICs. The model depended on persuading patent-owning pharmaceutical companies to ‘do the right thing’ and give MPP licences to the best new drugs, so it could sub-license them to generic companies to make high-quality, affordable versions and, where needed, develop new formulations to meet LMIC needs, such as fixed dose combinations and paediatric formulations. The importance of civil society, governments and key public health institutions such as the World Health Organization in bolstering that persuasion cannot be overestimated. This success led MPP to expand into hepatitis C and tuberculosis in 2015 and then into essential medicines across health in 2018. However, whereas
Charles Gore, executive director, Medicines Patents Pool
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