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Measures to stop the sale of unauthorised advanced therapy medicinal products in the EU
Following the detection by European regulatory authorities of some cases of unauthorised sales of advanced therapy medicinal products in the EU, the Spanish Agency of Medicines and Medical Devices (AEMPS) warns of the health risks that adverse reactions to these unauthorised advanced therapy medicinal products may cause, and highlights specific situations in which the general public should be particularly vigilant:
- Offering of the product as experimental or novel outside of an authorised clinical trial.
- When it is not possible to confirm that the use of the product has been authorised or approved for use by the AEMPS (or the national authority where the patient is located or resides).
- When the claimed benefits are superior to those of authorised treatments (where these exist) and are not documented in the medical literature.
In view of this situation, national authorities are constantly monitoring these medicines and implementing measures when unauthorised advanced therapy medicines are detected.
The European Commission proposes the Critical Medicines Act
In order to address shortages and ensure access to medicines, on 11 March the European Commission proposed the Critical Medicines Act, which aims to ensure that patients in the EU have access to the medicines they need when they need them. The text aims to:
- To improve the availability of essential medicines in the EU.
- To protect human health.
- To improve access to other medicines of common interest, which may not be available in certain markets.
Update on the draft law establishing the State Agency for Public Health
Last week the Health Commission of the Spanish Parliament approved the bill creating the State Agency for Public Health (AESAP). It is expected to pass through the plenary next week.
The AESAP will have roles in public health surveillance, in preparedness and response to future emergencies, in assessment and evaluation, in international public health and in health risk information and communication.