Is the time right for a Latin American Medicines Agency after the African Medicines Agency?
Everywhere you go now, there is fervent regional activity to harmonise medicines regulation. At the 17th International Conference of Drug Regulatory Agencies in Cape Town South Africa in November 2016, it seemed that even Africa had now joined the race.
The Continent already has the African Medicines Regulatory Harmonization Programme (AMRHP) to establish and improve standards and requirements related to the regulation of and access to safe, high-quality medicines for the African patients.
The AMRHP wants to develop national capacity within the 54 African national medicines regulatory authorities (NMRAs) to approve medicines in a timely manner and to ensure acceptable quality, safety and efficacy standards within their borders.
The African Union (AU) and its New Partnership for Africa's Development (NEPAD) together with the World Health Organization will then integrate all the NMRAs and create an African Medicines Agency (AMA) to be in place by 2018. The AMA like the European Medicines Agency (EMA) will be the one-stop-shop regulator to the entire continent.
Is the time right now for Latin America to have its own Latin American Medicines Agency (LAMA)? Can the 33 Latin American and the Caribbean countries enjoy the protection of one big regional agency when accessing quality and safe medicines in the region? Already there is a Pan American Network for Drug Regulatory Harmonization (PANDRH) programme underway.
The benefits of LAMA for Latin American patients can be extrapolated from Europe and the EMA that is serving over 500 million European patients and is one of the oldest regional medicines agencies
Set-up by the European Union in 1995, the EMA supports medicines regulation in 28 member states. The Agency is a single-entity responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the European Union (EU), ensuring quality, safety and efficacy standards for all patients in the EU market.
Just like in Africa, where the link between economic development and the medicines market in the region has been preserved by first delivering the AMRHP through the sub-regional development agencies like the East African Community and the Southern African Development Community, the LAMA and the harmonization programme could be rolled out in Latin America through sub-regional economic corporation bodies like MERCOSUR, Alianza del Pacífico, ALBA and Andean Community, preserving the link between economics, pharmaceutical markets and regulation.
Once sub-regional harmonization has been achieved, then the region could start looking at establishing LAMA and embedding it with the Union of South American Nations (UNASUR) whose goal is to build integration in the cultural, economic, social and political areas while respecting the current situation of each of the South American member nations.
A LAMA could go a long way in boosting patient confidence in the pharmaceuticals market in the region, especially with the introduction of innovative medicines like biotherapeutics and in particular biosimilars. This also means that we would have one body responsible for pharmacovigilance systems in the region. A common regulator would share market intelligence on the sale of substandard, spurious, falsely labelled, falsified and counterfeit medical products within the member states and rapidly address this problem through joint effort, and would also link up all patients, physicians, healthcare professionals and pharmacists to share information on adverse events in medicines usage in the region.
But there is something preventing this: Sovereignty! National Parliaments and National Medicines Regulatory Authorities view any external oversight of their medicines markets as a loss of their power and authority. They want to reserve the right to govern their markets themselves and consider any external regulatory mechanism as an interference with this right.
Very often lacking the expertise, infrastructure and trained professionals, National Medicines Regulatory Authorities try to introduce their own standards and regulatory pathways that do not meet international standards and best practice, or try to modify standards from the US Food and Drug Administration and EMA. The resultant national regulatory systems are disjointed, more so within the innovative medicines like biotherapeutics and biosimilars, and this puts at risk the health and wellbeing of patients though fragmented, weak, non-evidence based and very vulnerable national regulatory systems.
The Pan American Network for Drug Regulatory Harmonization, set-up in 1999, is trying to resolve the pre- asymmetries and anomalies within the framework of national and sub-regional health policies of ‘north-and-south’ and facing the challenge that all ‘Pan-American’ initiatives have had in the past when the large economies of the north try to work with the south. Latin American countries have very little in common with the large health systems of USA and Canada.
Patients in Latin America can drive this change and ensure they have a participatory, transparent and accountable Latin American Medicines Agency that not only establishes world beating evidence based standards, best practice and policy in regulating medicines, but also enforces the regulations to ensure quality and safe medicines for all.