Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

14 March 2019

Today, the Danish Medicines Agency signed an agreement with WHO to help build up drug regulatory authorities in low- and middle-income countries, including countries in Africa.

How can we strengthen the drug regulatory authorities in low- and middle-income countries to make sure essential medicine reaches the populations in these countries? And how can we improve the safety of the systems for distribution of medicines and medical devices in these countries? These are some of the challenges that WHO has put particular focus on in recent years as regulatory capacity building in the pharmaceutical area has been selected as a highly prioritised action area in low- and middle-income countries. 

Agreement signed in Geneva

As one of the first countries in Europe, Denmark will be contributing specifically to this work. Today, Director General of the Danish Medicines Agency, Thomas Senderovitz, has therefore signed an agreement between the Danish Medicines Agency and WHO in Geneva on this contribution.

Under the agreement, the Danish Medicines Agency will contribute in various ways to capacity building in the drug regulatory authorities of the selected countries to enable them to better fulfil the tasks related to, for example, the licensing of new medicines and the monitoring of side effects of medicines used by the country's population.

For improved global public health

Minister for Health, Ellen Trane Nørby, said:

"It is incredibly positive that Denmark has been asked to participate in this important work. We are asked because we are a top-performing drug regulatory authority, and this is an opportunity for Denmark to contribute to the realisation of the UN's global goal of improving public health worldwide. From our European work, we have considerable know-how in building scientific and trustful collaborations, which means the European population has access to effective and safe medicines. We must pass on this knowledge to those parts of the world who need it the most”.

"Drug regulatory authorities around the world play an increasingly important role in healthcare systems. They provide an overview of the medicines available in the specific country and are essential in ensuring the distribution of medicines to the populations. And it is particularly important to protect the legal supply chains in low- and middle-income countries where falsifications could be a challenge. Besides this, the establishment of systems to monitor side effects has a high priority", said Thomas Senderovitz, adding that also the establishment of systems for sending out timely and reliable communication from the authorities to healthcare providers and patients is a matter of high priority.

The task is too much to handle for most of them

According to WHO, as many as 70% of the world's drug regulatory authorities are incapable of fulfilling the tasks sufficiently. Among the remaining 30%, considered as self-managing, not all are capable of fully performing all of the tasks. WHO has shown an interest in involving the Danish Medicines Agency in the work with regulatory capacity building in low- and middle-income countries. One of the reasons is the positive result achieved by the Danish Medicines Agency in the Benchmarking of European Medicines Agencies (BEMA) in 2018.