Swissmedic's commitment Pioneering work for Africa

Lodovico Paganini, what can Swissmedic do to help people in poorer countries get better access to therapeutic products?

That depends on various players and factors, such as local shortages of staff and resources. In general though, we need better and more effective therapeutic products authorities. This will require several things, including a legal framework and a mandate to employ other tools, such as work-sharing and basing decisions on other authorities’ assessments. It will also require close international collaboration and dialogue between authorities. Swissmedic is active in several bodies internationally. We are helping harmonise standards and processes in medicinal products regulation, as well as sharing our know­ledge in the context of development cooperation. For instance, we contribute to various guidelines and guidance documents in joint working groups.”

Can you give us a real-life example?

“We have been conducting regulatory training in collaboration with the World Health Organization (WHO) since 2018. At one of these sessions recently, we used a case study involving a counterfeit medicinal product in a particular country. By coincidence, one of the participants, who worked for the Egyptian regulatory authority, had exactly the same issue, so we were able to put the two authorities in touch so they could resolve the problem together.”

“Major progress has been made in recent years.”

What do these regulatory training sessions involve, exactly?

“They take place twice a year, and we invite regulatory authorities from all round the world to Swissmedic in Bern. During the pandemic, training took place virtually. In addition to holding presentations, discussion sessions and workshops, we explain to attendees what we are doing to continuously improve and increase the efficiency of our processes. This helps them recognise areas for improvement in their own work environment and take appropriate action, for example by adapting their authorisation processes. Regulatory training sessions are always coordinated closely with the WHO, since it has the best overview of which authorities need most support and are also most likely to have an issue of their own to share and discuss with the group. To date, more than 250 people from over 40 national authorities have taken part. There is major interest both from within and outside Africa.”

What is the situation as regards therapeutic products authorities in Africa?

“Major progress has been made in recent years. The African Medicines Agency (AMA) has been launched, even though it is not yet operational (see box). To date, 15 member states of the African Union (AU) have ratified a common treaty. Huge efforts are being made to mobilise the remaining countries and raise awareness, but an undertaking of this type requires patience and costs money.”

In January, you were in Ghana for a conference on regulatory harmonisation. How did it go?

“The conference I attended takes place every two years under the auspices of the African Medicines Regulatory Harmonization Programme (AMRH). It provides a forum for managers, political decision-makers and regional economic communities in Africa. It is primarily about African cooperation at national, regional and continental level, but foreign or external partners are also involved, such as Swissmedic or the European Medicines Agency (EMA). African countries and regions obtain support in setting up effective regulatory networks for medicinal products. The aim of the programme is to improve access to vital medicines. We were invited as a technical partner and are involved in planning and implementing the technical working groups’ activities. These include designing specific courses, for example, promoting knowledge sharing or developing guidelines and work procedures.”

What are the biggest challenges associated with therapeutic products oversight in Africa?

“The primary challenge is overcoming the lack of resources. This includes a shortage of staff and money, as well as the disadvantageous legal framework. There are also political issues that often get in the way of efficiency. Nevertheless, significant progress has already been made. Many countries have modified their legal requirements, for example.”

What role can Swissmedic play in this process?

“We can’t implement projects on our own, but our expertise is in demand in many processes relating to medicinal product authorisation and monitoring. For example, we work closely with the WHO, which has a good overview of all activities and involves us as needed. That means we can consult with them on all enquiries.”

Swissmedic was elected chair of the technical partners at the AMRH. What does this election mean for Swissmedic?

“We see it as an honour, but also a major responsibility because we now have direct influence on how the participating authorities plan their activities and set priorities. When gaps are identified, support activities can be coordinated with all the organisations that make a contribution to development cooperation, such as other therapeutic products authorities, foundations and international organisations. At the bottom line, it’s about all participating partners contributing their knowledge and capabilities. Swissmedic has been an official partner since 2018 and attends AMRH Steering Committee meetings as an observer. Our election is proof that people have confidence in our agency and in Switzerland’s humanitarian tradition.”

Which other key players are on board?

“Our closest partners are the Swiss Agency for Development and Cooperation (SDC), the World Health Organization (WHO) and the Bill & Melinda Gates Foundation (BMGF). These organisations have a very strong presence on the African continent and are committed to improving healthcare provision worldwide, combating poverty and providing access to education. The BMGF has huge experience of regulatory systems and is financing our activities in this area. The finance agreement between Swissmedic and the BMGF guarantees project-specific financial support that is intended to improve access to therapeutic products in low- and middle-income countries.

In addition we also maintain close cooperation with the responsible authorities and organisations on the ground, particularly AUDA-NEPAD, the African Union Development Agency, which is comparable to the SDC in Switzerland.”

One project concerning the authorisation of global health products, in other words therapeutic products that are also used outside Switzerland, is up and running. What are the latest developments on that front?

“The aim of this project is to try to speed up authorisation applications in the target countries. It was launched six years ago and is one of the focal areas of our efforts alongside regulatory training. As yet, we have only been able to completely review and authorise one application under this framework – a medicine to prevent uterine bleeding. We had invited nine authorities to deal with this submission with the aim of building up their own capacities and trust in the process. Ultimately, we achieved an outcome where all participating authorities were able to authorise the medicinal product in their country within an average of six months. This is very fast compared to the authorisation times we are otherwise familiar with in Africa. The main aim is to make the important products available to patients.”

Where is the greatest potential in overall cooperation?

“Definitely in dialogue with other authorities. We are one of the few authorities to provide its own training. We are currently finalising a study that demonstrates the successes and effects of our regulatory training sessions, which we hope will motivate authorities in other resource-rich countries to get actively involved. In this respect, Swissmedic is a kind of pioneer.”