Ministry of Health sources: The Commission recognizes that the lack of medicines is a global problem

The Commission recognizes that the lack of medicines is not only a Greek or European problem, but global problem, Health sources point out.

“The European Commissioner for Health Stella Kyriakidou accepted yesterday that the problem of drug shortages is global, and occurs not only in European countries but also in the USA, the UK and Canada” they say.

Ms. Kyriakidou, in response to the letter of the Minister of Health, Thanos Pleuris, who took the initiative to request that measures be taken at the EU level, even underlines that drug shortages are long term challenge in the EU but also worldwide.

Here is the Commissioner’s letter:

“Dear Minister,

I would like to thank you for your letter dated January 3, in which you describe your concerns regarding the shortages and continuity of supply of medicines in Greece and the EU.

The continued availability of safe, effective and affordable medicines for EU patients is my top priority. Patients should be able to access the medicines they need in both crisis and normal times. Therefore, our goal is clear: to ensure access to medicines for all patients in need and to avoid any disruption of the medicines market in the EU.

Drug shortages are a long-term challenge in the EU and worldwide. Looking ahead to try to make things better, our Medicines Strategy for Europe with the upcoming reform of medicines law is our answer to improving the supply of medicines in the EU and avoiding shortages. To inform appropriate policy measures, we have carried out extensive work on this issue. This includes the EU Commission’s study on shortages and a Working Paper published on security of supply, which is the result of a structured dialogue with industry, Member States including national competent authorities, health professionals, academia and patient representatives, to better understand the functioning of global supply chains and to prepare to take possible actions to improve their resilience. The findings of the structured dialogue will further update pharmaceutical law reform and may cover better coordination to monitor, manage and avoid shortages and stronger obligations for supply, early notification of shortages and withdrawals, and enhanced stock transparency.

Looking at the current situation, we have a coordinated system of monitoring and shortage mitigation mechanisms in place to address ongoing availability challenges. The European Medicines Agency (EMA) works with National Competent Authorities, industry and other relevant stakeholders in a collaborative way to resolve shortages. This includes information exchange between EMA and National Competent Authorities through the Single Point of Contact working group. Discussions with industry take place when the task force identifies critical deficiencies so that mitigation measures can be taken – this is really the critical point. We must realize that this is a very delicate process of cooperation between different authorities, representatives of Member States and industry. Where the working group cannot find a solution to a shortage, this issue is escalated to the Medicines Shortages Steering Group, which includes EMA executive-level representation.

In addition, Member States must refrain from taking national measures that could affect the EU’s internal market and prevent access to medicines for those in need in other Member States. In this regard, whenever we are notified of measures that could have such an impact, the EU Commission asks the Member State in question to withdraw them.

Last but not least, the Health Emergency Preparedness and Response Authority (HERA) will strengthen Europe’s ability to prevent, detect and rapidly respond to cross-border health emergencies, ensuring the development and the equitable distribution of essential medical countermeasures to address supply chain vulnerabilities and help prevent shortages.
I would encourage you to use existing mechanisms. So it will be important to be more specific in these forums about the type of product that is in short supply. I can assure you that the European Commission will support you in any such endeavour. The EU Commission and the EMA – also thanks to their new extended mandate on shortages – are fully committed to ensuring the timely and continuous supply of life-saving medicines to European patients under all circumstances and we count on your commitment and cooperation in this regard.” .

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