The European Union (EU) is on the cusp of approving clearer rules governing the joint procurement of medicines and medical devices by member states at the EU level. The imminent rule changes will apply to crisis-relevant supplies of medical countermeasures, including both vaccines and therapeutics, where the threshold of a ‘serious cross-border threat to health’ is met.
The imminent rule changes strengthen and clarify existing regulations, progressing past joint procurement of pandemic medical countermeasures. The aim is to build on ‘lessons learned’ during the Covid-19 pandemic by organising a collective EU response to future potential health emergencies. The pharmaceutical industry is relatively relaxed about most of the short-term policy implications so long as they also apply to emergency situations. However, this may have driven some complacency. The pharmaceutical industry hopes that cross-border purchases of medicines remain a limited possibility, but this appears to be a futile hope. Czechia and certain other participating countries have not let go of a lingering policy objective to broaden the concept of joint purchases into even more domains, and have made no secret of wanting future joint purchases of orphan medications.
The new mechanism for collaboration will undoubtedly lead to other uncertainties. Among these is how the definition of a serious cross-border health threat will be practically applied when the Health Emergency Preparedness and Response Authority (Hera) works with participating countries to identify and implement priorities for joint procurement. Scope within the regulations suggests that the definition should, for the most part, apply to communicable infectious disease health threats. Some non-communicable diseases are, however, clearly covered and openly talked about for possible joint procurement prioritisation.
The new guidelines take a narrow approach to dealing with the voluntary joint purchasing of essential and emergency medical countermeasures during health emergencies across participating European countries. This gives the EU a bigger role in reacting to infectious disease threats and other health threats that have a cross-border dimension. However, certain national-level officials have suggested that it may eventually mean more, leading to questions about how much more and whether this is politically too steep a course of action to take. Most observers are skeptical regarding possible collaborations beyond the scope of the new framework, at least over the short-to-medium term. Hindering factors include the basic tenet of EU-level policymaking, which has seen member states being unwilling to surrender certain powers in this field to the EU. Despite this, the ambition is present and not easily discounted.
While clarifying procedures for joint procurement, the text of the agreement also increases rules about transparency and introduces the possibility of an exclusivity clause in contracts. Regarding the provisions around transparency, the European Commission will be obligated to inform the European Parliament about all joint procurement procedures and grant access to Members of the European Parliament to relevant contracts, while ensuring the protection of confidential commercial agreements. The clause covering parallel procurement and negotiation strictly limits the establishment of parallel bilateral negotiations by participating countries for the joint purchasing of a product at the European level. This lever restricts national-level governments from running parallel negotiation processes alongside participating in joint EU procurement and is likely to force countries to make either-or decisions.
Some joint EU contracts for intensive care unit (ICU) medicines have been linked to procurement delays in 2020, thereby resulting in governments organising national procurement in addition to EU joint procurement. However, by ensuring that the only channel participants have for securing medical countermeasure supplies is either at the national or EU level, the outcome should see less in the way of EU fragmentation and solo policy efforts. The question of whether this will lead to more efficiencies and fewer contract delays remains debatable.
The new framework has many of the characteristics needed to succeed in delivering joint advance purchases. More extensive use of the multi-country regional procurement mechanism has the potential to support the development of a European Health Union, a concept that can be seen as a starting point for more EU integration in the healthcare field. The improved performance of centralised procurement actions is reasonably likely to facilitate equitable access to medical supplies, better security of supply and favourable prices, in addition to reducing some operational costs and administrative burdens.