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The EU is establishing a Health Emergency Response Authority to deal with future threats(Source:Alamy)

Plans to create an EU Health Emergency Response Authority have been welcomed by European off-patent industry association Medicines for Europe. However, the group has emphasized that current policy and regulatory weaknesses – particularly in relation to procurement policies – must be addressed if HERA is to successfully counter future health threats.

In her “state of the union” address on 15 September, European Commission president Ursula von der Leyen spoke about establishing HERA – seen as an equivalent to the US Biomedical Advanced Research and Development Authority – and its mission to support the development, manufacturing and deployment of medical countermeasures deal with future health threats. (Coronavirus Notebook Nobel Laureates Press Germany To Back Vaccine IP Waiver)

Von der Leyen said the EU had the “innovation and scientific capacity, the private sector knowledge, we have competent national authorities. And now we need to bring all of that together, including massive funding.” The Commission is proposing a new “health preparedness and resilience mission” for the whole of the EU, backed up by investment of €50bn ($58.9bn) by 2027.

In response, Medicines for Europe welcomed the move but underlined that “HERA must address outstanding weaknesses in the EU Pharma framework to be successful.”

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

HERA “will need to be an efficient agency with strong links to healthcare industries, including Medicines for Europe,” the association said. And “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.”  

Joint Procurement System Is ‘Dysfunctional’

But the association said that for HERA to be successful, the current “dysfunctional joint procurement policy must change” before being used for the new authority.

“Joint procurement should not create distortions into the internal market,” Medicines for Europe insisted, urging the provision of “accurate demand estimates with clear volume commitments in joint tenders.”

The procurement system “should operate only under an exclusivity principle where participating countries commit to source their supplies from the winners of the joint procurement procedure,” the association said, underlining the need to “be able to efficiently and swiftly contract awarded suppliers and provide clear timelines and specifications for delivery of purchased goods.”

Medicines for Europe also said it was important to improve transparency around procurement, suggesting “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.”

Aside from its specific criticisms around procurement, Medicines for Europe also maintained that HERA’s success would rely on effective co-ordination between manufacturing associations and EU authorities, “via the joint industrial co-operation forum.”

EU regulations should be adjusted to prioritize the supply of essential medicines, the association urged, also calling for the elimination of proposals for redundant manufacturing capacity.

“It is not possible to predict which medicines will be needed in a future crisis,” Medicines for Europe commented, “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 dialog” (see sidebar). (EU Structured Dialog Offers Opportunity To Secure Supply)

“In a crisis, regulatory flexibility and competition law adaptations are more successful tools to enable manufacturers to respond to surges in demand for medicines,” Medicines for Europe said, with the association having been at the forefront of efforts in this area during the early stages of the COVID-19 pandemic. (EU Rips Up Competition Rulebook To Allow Collaboration On Coronavirus)

Other priorities highlighted by the association include making provisions for “efficient strategic reserves of medicines that factor in waste,” adding that “costly destruction that should be avoided.” Reserve policies “must be coherent and avoid distorting supplies of medicines to certain (smaller) EU countries,” the association underlined.

Medicines for Europe also urged the EU to work to “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.”

Finally, the association repeated its call to “digitalize the sector and its regulatory systems,” including “putting order on to existing digital health initiatives.” (EU Industry Renews Call For Digital Regulatory Infrastructure)

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