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Europe and medicines

 Editorial  The European Commission is due to propose changes to European pharmaceutical legislation in early 2023, in what has been presented as a major revision. No doubt the industry's lobby groups will attempt to shape the legislation in their favour. But civil society organisations will also have their say.

Within the European Union, many aspects of healthcare policy are handled at the national level. But pharmaceutical policy, as well as legal and administrative decisions concerning medicines, are mostly made at the European level. The European Commission, the Council of the European Union, the European Parliament and the European Medicines Agency (EMA) have a key role, from determining the legal framework governing medicines, through the granting of marketing authorisations or their withdrawal on pharmacovigilance grounds.

The European Union is not a distant or foreign entity that we are powerless to affect. European citizens participate in European decisions, responsibilities and activities through their members of parliament, various national institutions and patient groups.

If we are to advance healthcare policy, it is possible and useful to challenge European institutions, as shown by the non-governmental organisation Corporate Europe Observatory, which shines a spotlight on the influence of industry lobby groups on European bodies. It is also possible to take action alongside civil society, especially as part of a coalition, something that Prescrire does for example within the European Alliance for Responsible R&D and Affordable Medicines.

To cite another example, the European Commission had to abandon its plan to allow drug companies to advertise prescription-only medicines to the general public, thanks in particular to action taken by the Medicines in Europe Forum, in which Prescrire participated. More recently, Prescrire challenged the EMA's transparency policy, prompting a reaction from the Agency's Executive Director (see “European Medicines Agency: transparency policy marred by too many failings” Prescrire Int n° 237> HERE).

The European Commission is due to propose changes to European pharmaceutical legislation in early 2023, in what has been presented as a major revision (see "Impending changes to European pharmaceutical regulations: part I" Prescrire Int n° 243 > HERE). No doubt the industry's lobby groups will attempt to shape the legislation in their favour. But civil society organisations will also have their say. The fact that the Commission has included issues such as drug shortages and affordability among its priorities already reflects the concerns of patient groups and healthcare professionals.

There is every good reason, therefore, to mobilise and join forces with representatives of European civil society who are committed to seeing more consideration given to the interests and concerns of Europe's citizens.

©Prescrire 1 December 2022

Source: "Europe and medicines" Prescrire International 2022; 31 (243): 283. Free

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