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15 February 2022
CARE, - Medicines

In January 2022, EFA participated in a targeted workshop on the EU General Pharmaceuticals Legislation that the European Commission has opened for revision. EFA participated in one stakeholder consultation to bring the voice of allergy, asthma and chronic obstructive pulmonary disease (COPD) patients and was delighted to be invited to the targeted workshop.

During the workshop, the agency contracted to conduct a study on the evaluation and impact assessment of the general pharmaceutical legislation informed participants about the main trends of the consultation results. In general, stakeholders including patients welcome a revision of the general pharmaceuticals legislation.

The study also sheds light on the market authorisation process ran at the EU level through the European Medicines Agency and compared this to similar regulatory bodies such as the US Food and Drug Agency (FDA) and the Japanese agency. In comparison, the EMA appears as slower and less attractive for companies to get their medicinal products assessed, and a future revision of the legislation could help improve that.

The workshop served as a space to voice issues and concerns on specific topics, and EFA participated in a breakroom on facilitating innovation. We contributed to the discussion on existing legislative gaps in the regulatory chaos for drug-device combinations, the current limbo for medicines addressing the microbiome and the use of phage therapies, and our patient call to maintain hard copy Package Leaflets (PL) on top of the future digitalisation of this information.

On the topic of drug-device combinations, EFA has recently learnt from an analysis conducted by the European Federation of Pharmaceutical Industries Associations (EFPIA) that most of allergy, asthma and COPD medicines fall under this category of products. Their dual nature of being a medical device carrying a medicine such as inhalers or adrenaline auto-injectors make it difficult for a patient to assess the type of product they are using, a situation that also impacts the way these products are being assessed, evaluated, and monitored once in the market.

EFA is currently investigating the current legal framework for these medicines, that are of daily and widespread use among our disease areas. We will inform our members about the outcomes of our research accordingly.

To know more about the EU General Pharmaceutical legislation revision, visit the Commission website.