How improving access to essential medicines can help reduce inequities

A stable supply of essential medicines is a prerequisite for any functioning healthcare system. Yet basic health products are all too often unavailable to people in low- and middle-income countries (LMICs), even though the vast majority of these medicines are off-patent. This gives generics companies enormous power to ensure that vital drugs are widely available and affordable where they are needed most.

Given the strides being made by science in tackling diseases afflicting rich and poor alike, the case for action has never been greater. The spectacle of poor countries struggling for a fair share of vaccines and other critical supplies during the COVID-19 pandemic underscores the shortcomings of the current system. Without decisive steps by industry and governments to close this chronic healthcare supply gap, millions of patients and their families will be condemned to more suffering, unnecessary deaths, and loss of livelihoods.

When it comes to getting crucial medicines onto pharmacy shelves in rural villages across Africa or poor areas of megacities in Asia and Latin America, the world’s generic pharmaceutical manufacturers have an unparalleled role to play. By manufacturing at scale, they can supply billions of doses of medicines that offer the same benefits as brand-name versions but at a lower cost. Indeed, their products have become a bedrock of global healthcare, given that 90% of medicines included on the World Health Organization (WHO) Model List of Essential Medicines are no longer under patent.

Yet a lack of reliable local production and disjointed supply chains mean that generic medicines are too often out of reach.

The good news is that there are numerous opportunities to improve the situation, ranging from smarter procurement and an overhaul of regulatory systems to technology transfers and increased local manufacturing. Delivering on these action points, however, requires coordination and commitment from businesses and political will from governments.

In a bid to address these bottlenecks and mobilise a coordinated response, the Access to Medicine Foundation and the World Economic Forum convened a meeting of industry leaders, policy-makers and regulators involved in generic medicine on the side-lines of the 76^th World Health Assembly in Geneva in May 2023.

This group of nearly 60 high-level experts concluded that the world had a unique window, in the wake of COVID-19, to stabilise supplies and solve global access through stepped-up action by companies working alongside governments and multilateral organizations.

Specifically, the generics industry can do more to collaborate with local manufacturers in LMICs to create a wider pool of producers. This can help prevent shortages and stockouts caused by over-reliance on international suppliers. Technology transfer, which gives local manufacturers the technical know-how to make high-quality medicines, will be a key component of this.

There are also growing opportunities for the generics industry to strike licensing agreements with big pharmaceutical companies to allow for the generic production of on-patent medicines. Such licences issued by Big Pharma give lower-cost producers a chance to supply patients in poor countries with a wider range of innovative therapies.

The importance of this kind of voluntary licensing is only going to increase as a greater number of novel medicines are developed – not only for infectious diseases but also non-communicable ones like cancer, which are a growing burden in poorer countries. In some areas, such as HIV treatment, voluntary licensing agreements are already well established and are delivering important results, as exemplified by a new injectable HIV-prevention medicine that is to be manufactured as an affordable generic in South Africa for the first time. But there remains huge scope to increase the use of voluntary licensing in more areas of medicine.

In addition, the generics industry has a chance to both grow its business and expand patients’ access by investing in adaptive R&D to make appropriate products for low-income settings, such as the development of heat-stable medicines for hot countries.

Finally, a whole new market is emerging for off-patent biological medicines, known as biosimilars. These products have been sold in high-income countries for more than a decade, but many more opportunities are now opening up as patents expire on a range of blockbuster biological products to treat cancer and immune system disorders.

So far, biosimilars have made limited inroads in poorer countries. However, several companies have demonstrated it is perfectly viable to manufacture these complex medicines low-income settings, while the WHO has given impetus to their use by covering the first biosimilars in its prequalification assessment scheme.

But none of these actions will cut through for patients on the ground unless public sector actors, including governments and multinational health organizations, also play their part. In particular, public procurement practices need to change so that local manufacturers of medicines are encouraged to invest in locally based factories.

This means taking a much more holistic approach to public tenders for bulk purchases of medicines and making sure that contracts do not go exclusively to multinational suppliers. Fundamentally, tenders should not be based on price alone; they must also take account of quality and supply-chain resilience.

Governments can also do more to work together on coordinated or pooled procurement – and similar cooperative efforts are also needed when it comes to regulation.

Africa is especially hampered by a patchwork system of medicine regulation that is often inefficient, resulting in poor quality controls and unnecessary obstacles to the rollout of products. This makes it critical to get the proposed African Medicines Agency (AMA) up and running, to improve access to safe, effective, affordable and quality products. Although the AMA came a step closer to reality recently when Rwanda agreed to host the body, several major African nations have still yet to ratify its founding treaty.

Clearly, there is much work to do by all stakeholders across the private and public sectors to build a supply system with the resilience to withstand future shocks. We cannot afford to wait for the next health crisis or pandemic to ramp up investments in local manufacturing capacity and to overhaul the procurement and regulatory systems that billions of people in LMICs need to ensure access to essential medicines.