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TIF’s Point of View: Medicines Regulatory Systems – Continued Strengthening Is Required

Access to quality-assured medical products improves health and saves lives. Nevertheless, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF). National Regulatory Authorities (NRAs) are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient.

Today, the unrelenting COVID-19 pandemic has highlighted more than ever before the need to effectively address challenges to access essential medicines and other health commodities. Drug shortages, stockpiling of medication and supplies, high prices, lack of coverage, poor purchasing and distribution, and the circulation of falsified health products have already exacerbated this once in a century global health emergency.

Way before the COVID-19 pandemic, it was already estimated that 2 billion people lacked regular access to essential medication[1]. Narrowing this gap has been a long-standing global public health priority, but despite decades of donor funding and international programmes, availability of essential medicines remains suboptimal. In light of the development of vital products to treat and prevent COVID-19, rational policy decisions about how to secure equitable access and affordability of these products globally, are indispensable.

In an endeavor to promote the development of high-priority medicines and vaccines for patients in low- and middle- income countries outside the European Union (EU), the European Medicines Agency (EMA) has developed the EU-M4all procedure. Through this procedure, the European regulatory authority can assess innovative or generic medicinal products that address unmet medical needs or are of major public health interest for use outside the EU, in collaboration with the WHO and the relevant non-EU authorities to ensure that specific disease expertise and local knowledge are taken into account. Thanks to the EU-M4all evaluation, 90 non-EU countries have authorized several medicines for use from 2004 to date[2].

More recently, the EMA has taken another step forward, offering to pharmaceutical companies the possibility to apply in parallel for both a centralized EU-marketing authorization and a scientific opinion under EU-M4all for their medicines to be utilized outside the EU. The novel EMA initiative aims at time-saving on the one hand, and reduced duplication of efforts on the other, thus allowing a greater number of patients to gain easier and more timely access to essential medication in order to preserve their health and well-being.

National regulatory authorities (NRAs) and pharmaceutical regulatory regimes are key to promoting access and quality of life-saving drugs. However, NRAs that have fragmented, unnecessarily convoluted, ineffective, and poorly enforced regulations contribute to poor health outcomes, wider health and socioeconomic inequities, and higher patient spending on healthcare[3]. Bolder international action to establish a global access to a medicines regime charged with ensuring that no one is left behind and that anyone who requires essential treatment for COVID-19 or other health maladies will get it, entails, amongst other things, the reduction of the often overwhelming regulatory frameworks´complexity, particularly prominent in low- and middle-income countries, such as in Sub-Saharan Africa.

The importance of regulatory harmonisation and the urgent need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner, has recently been brought to the forefront with the African Medicines Agency (AMA) Treaty made at the 32nd ordinary session of the Assembly of the African Union (AU) in 2019.

A strong unified regulatory system would greatly contribute to combating falsified and substandard medicinal products on the African continent. Coordinated market surveillance, centralised information collection and sharing of data between countries is expected to complement and strengthen national efforts to reduce the circulation of falsified products and increase access to safe and innovative products. Furthermore, the establishment of the African Medicines Agency (AMA) will open-up more opportunities to boost local manufacturing capacities, country participation in clinical research and other scientific development activities.

Although there has been political support, legal commitment from more countries remains to be secured for the continent-wide regulatory African Medicines Agency to finally become a reality. The Treaty has so far been signed by 19 countries, but only 8 out of the necessary 15 have ratified it. Further delays in the establishment of an African Medicines Agency (AMA) undermine the timely access to effective, quality therapies, and vaccines for all patients across Africa.

The Thalassaemia International Federation fully supports the International Alliance of Patients΄ Organisations (IAPO)‘ call to Heads of State of the African Union to ratify the AMA Treaty, firmly believing that the latter will unquestionably strengthen our efforts for the safety of patients with thalassemia and sickle cell disease living on the African continent, and their access to quality, safe & effective medicines.


[1] Access to medicines: making market forces serve the poor. 2017.

[2] Medicines for use outside the EU –EU-M4all.

[3] Barton, Iain, et al. „Unintended consequences and hidden obstacles in medicine access in Sub-Saharan Africa.“ Frontiers in public health 7 (2019): 342.

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