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HERA must address outstanding weaknesses in EU pharma framework to be successful

Date

16 Sep 2021

Sections

Health & Consumers

Brussels, 16 September 2021

Medicines For Europe strongly supports the EU’s drive to learn from COVID-19 and to improve its crisis preparedness and response. The proposal to establish a European Health Emergency Preparedness and Response Authority (HERA) is an important contribution to that policy and we support its creation and will contribute to its work for the security of all Europeans.

Having been at the front lines of the COVID-19 pandemic, supplying critical medicines in a crisis, we acknowledge the efforts of the European Commission and the need for more efficient policies to manage future crises

HERA will need to be an efficient agency with strong links to healthcare industries, including Medicines for Europe.

A successful HERA must:

  • Ensure coordination between manufacturing associations & EU authorities via the joint industrial cooperation forum
  • Make sure EU regulations are adjusted to prioritise supply of essential medicines
  • Eliminate the proposal for redundant manufacturing capacity
    • It is not possible to predict which medicines will be needed in a future crisis and maintaining redundant manufacturing capacity is neither feasible nor a good use of taxpayer money. Instead, pharmaceutical policy should encourage the sustainability of manufacturing investment in a wide range of medicine production types as outlined in the Structured Dialogue.
    • In a crisis, regulatory flexibility and competition law adaptations are more successful tools to enable manufacturers to respond to surges in demand for medicines. 
  • Include provisions for efficient strategic reserves of medicines that factor in waste and costly destruction that should be avoided. Reserve policies must be coherent and avoid distorting supplies of medicines to certain (smaller) EU countries.
  • Overcome the significant regulatory differences applied by Member States to most emergency (nationally licenced) medicines which limits the possibility to allocate stock efficiently in a crisis.
  • Digitalise the sector and its regulatory systems. This includes putting order on to existing digital health initiatives. 

Dysfunctional joint procurement policy must change

The European Commission must correct the joint procurement system before using it for HERA. Most importantly:

  • Joint procurement should not create distortions into the internal market.
  • Provide accurate demand estimates with clear volume commitments in joint tenders.
  • Should operate only under an exclusivity principle where participating countries commit to source their supplies from the winners of the joint procurement procedure. 
  • Be able to efficiently and swiftly contract awarded suppliers and provide clear timelines and specifications for delivery of purchased goods.
  • Be more transparent with the possibility for industry to comment on tender criteria and the obligation for the Commission to clarify that criteria publicly and to reply to individual queries from companies in a timely manner.

 

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