Guaranteeing access to quality medicines and healthcare to strengthen the health system in Europe

By Susanne Keitel, Director at European Directorate for the Quality of Medicines & HealthCare (EDQM)

Access to quality healthcare is one of the fundamental rights protected by the Council of Europe, which has entrusted its activities in this area to the European Directorate for the Quality of Medicines & HealthCare (EDQM). With multicultural staff and experts drawn from all over Europe, the EDQM works to support health systems at national and European level and enhance the protection of patients by providing legally binding quality standards in the form of the European Pharmacopoeia (Ph.  Eur.), which comprises strict quality standards for the production and control of medicines. The Ph. Eur. was one of the first building blocks in the edifice of European health co-operation.

Today, 39 European countries plus the EU collaborate and co-ordinate their efforts in the implementation of Ph. Eur. standards in their territories. As part of its pharmacopoeial activities, the EDQM also establishes and produces the physical reference standards necessary to confirm – through testing – that these quality requirements for medicines are met. These reference standards are essential to ensuring both the quality and availability of medicines for patients in every country that applies the Ph. Eur., in Europe and beyond. Furthermore, a rigorous procedure verifying and attesting the quality of active pharmaceutical ingredients, the Certification of Suitability to the Ph. Eur. Monographs (CEP), has been in place since 1994, contributing to health protection and facilitating marketing authorisations not only in Europe, but further afield.

Quality assurance in medicines stands on deep foundations, such as the analytical competence of the European Network of Official Medicines Control Laboratories (OMCLs), which was set up to ensure the quality of medicines on the market and brings together more than 70 official laboratories in 43 countries, and seven non-European partner laboratories.

Impartial and independent, the network facilitates the pooling of resources and information on the latest technologies to save public money and share expertise and best practices.

Its work gives participating states the support they need to monitor the quality of medicines at national level. The scope of the EDQM’s mission has progressively increased since its creation in 1964, extending to cover healthcare, standards for substances of human origin (SoHO), the fight against falsified medical products and consumer protection issues, such as cosmetics and food contact materials. Today, the EDQM’s remit also encompasses the definition of standards upholding the principles of good pharmaceutical care, i.e. that medicines, in addition to being of good quality, are also administered correctly; co-ordinating the European Network of Official Cosmetics Control Laboratories (OCCLs) to help enforce European regulations; and elaborating harmonised measures to ensure the safety of materials and articles for food contact, supplementing EU and national legislation. The COVID-19 pandemic has been a real stress-test for Europe’s health systems, as illustrated by efforts to develop and distribute vaccines. But the EDQM has contributed to ensuring the timely release of newly authorised COVID-19 vaccines to the market thanks to the work of its Network for Official Control Authority Batch Release (OCABR) acting as the cornerstone in the mandatory mutual recognition of official control authority batch release for human vaccines.

The EDQM also conducted critical work on viral vectored vaccines by defining control strategies for these new products.

In times of crisis, the EDQM can leverage expert networks to bring new contributions and perspectives that will anticipate the needs of professionals and manufacturers in the medicines sector.

By attracting and relying upon the best experts from all over the world and taking part in a number of joint programmes, co-operation activities and networks, the EDQM strengthens its positive impact, increases its reach and allows for agile and rapid responses. Moreover, it is widely recognised that the financial burden of protecting patient and consumer health is becoming increasingly onerous.

Activities run exclusively at national level – without sharing of resources and experience – tend to be more expensive.

The advantage of networking in this context is evident, since member states participating in the EDQM’s work can make the best use of limited resources. By providing legal frameworks founded in fundamental human rights, by sharing scientific excellence, technical expertise and know-how, and by coordinating surveillance activities, the EDQM therefore supports national authorities in delivering the best possible healthcare to their citizens.

At the forefront of standard-setting for the quality control of medicines and their safe use since 1964, the EDQM has helped shape the European regulatory system, building upon successive partnerships and joint programmes between the Council of Europe, the EU and their respective member states.

Everyone today is acutely aware that the demand for health and pharmaceutical standards that are consistent at European and global level has become increasingly important to safeguarding quality and improving access to medicines and good quality healthcare.

Having harmonised approaches and policies in establishing these standards can greatly contribute to achieving this goal, in addition to guaranteeing that fundamental rights remain deeply enshrined in health policies in Europe.