Brussels, 09 November 2021

Having been on the front line of the pandemic, supplying critical medicines needed in Intensive Care Units, Medicines for Europe strongly supports the establishment of the European health emergency preparedness and response authority (HERA).

The EU must be able to react quickly and in a coordinated manner in future health crises.  Some key lessons learned from the Covid-19 crisis should be included in the current regulation for the management of future health crises:

1. HERA should develop advanced planning scenarios with relevant industry to prepare for future risks. The current regulation is too reactive.
2. A definition of “surge demand projection” is essential for industry to reorganise production to meet high demand in a crisis. The standard EU definition of a shortage is inadequate for a crisis situation.
3. HERA should focus on allocation rather than production capacity. In a crisis, industry needs to reallocate production to the demand surge while protecting the supply of medicine to the patients that rely on that production for chronic or other (non-crisis) health needs. In a crisis, the Commission must also enforce EU solidarity regarding the allocation of critical medicine to prevent hoarding.
4. Joint Procurement should be used only in a serious healthcare crisis setting, rules should be more transparent and adapted to the specificities of generic medicines which are usually licenced nationally (only 10% of medicines have EMA or EU-wide approvals).
5. European strategic reserves should be smart and targeted. They should not distort the Internal Market. They should be targeted based on a risk assessment to determine medicines or therapeutic focus areas and they should be proportionate to prevent the wasteful destruction of unused medicine.

For more information, see our position paper on Lesson learned from Covid-19- June 2020