by | April 29, 2015 | Uncategorized

Joint Procurement of medical countermeasures: A Solidarity Tool?

On 29 April 2015, Public Health England organised a workshop for the European Commission in Luxembourg on the joint procurement of medical countermeasures, which featured a host of speakers from different Commission Directorate Generals, EMA, ECDC, WHO, and industry. One of the key messages was that the new Joint Procurement Agreement (JPA) tool is potentially available for many different countermeasures as long as they fall into the legal framework of serious cross-border health threats.

The purpose of the meeting was to discuss the state of play of the Joint Procurement Agreement signed by the Commission in June 2014, identify good practices and explore how the EU and the Member States can work together effectively to make best use of this voluntary tool for any type of serious cross-border health threat.

John Ryan, Acting Director of the DG SANTE’s public health unit, explained that what makes the JPA unique is that it takes the form of a ‘budgeting implementing act’ which is not subject to the regular legislative process of (co)-decision. hence it is designed to free Member States of existing barriers including at national level, with full administrative and operational support by the Commission.

In practice, at least four Member States need to come together in order to ask the European Commission to launch a joint call for tender. The benefits of joint procurement differ depending on the stakeholder: for Member States – especially smaller countries with lower purchasing power – it translates into, inter alia, increased means and negotiating power, more equitable access to medical countermeasures and better security of supply. For industry, potential benefits that were mentioned include the reduction of administrative burden and costs, predictability of turnover, improved production planning (in terms of capacities, resources, etc.) and better predictability of required supplies. Hence the JPA was described as ‘an important step for solidarity in Europe’.

There are two important Committees under the JPA, namely the Joint Procurement Agreement Steering Committee (JPASC) tasked with general issues such as the type of medical countermeasures to be procured and decisions regarding the order of procurement procedures, and the so-called Specific Procurement Procedure Steering Committee (SPPSC) whose decisions are technical and include the type of procurement procedure (e.g., open call for tender, restricted, competitive dialogue, innovative partnership) and type of contract (e.g. direct, framework, managed stockpiling, reservation contract) to be used, as well as other considerations e.g. what type of vaccine should be purchased, dosage, packaging, etc. Moreover, it is important to decide on clear selection criteria (e.g., on what basis are tenderers accepted / rejected?), as well as on criteria for awarding the contract (e.g. on what basis should tenders be rated?).

So far only two joint procurement processes have been initiated, the first on pandemic vaccines and the second on personal protective equipment, an issue that has come to the fore during the ongoing Ebola crisis. The Commission’s role will also be to analyse emerging problems in national markets (e.g. vaccine shortages) and then bring this information to the JPASC which will decide if and when to launch a new JPA procedure.

All Member States have either signed up to the JPA or expressed an interest, with the exception of Poland. However, the possibility to join at a later stage is there.

Crucially, the JPA covers many types of cross-border threats including pandemic situations, communicable diseases, antimicrobial resistance, protective equipment, etc. as referred to in Decision 1082/2013/EU. Hence the JPA may also be used as a preventative tool for better preparedness. The term ‘medical countermeasures’ is equally broad and comprises medicines, medical devices, and other services and goods that could be used to ‘mitigate or combat serious hazards to health of biological, chemical, environmental or unknown origin’.

During the discussion a number of issues were raised including various financial, legal and administrative implications for the participating Member States, but also potential uses and misuses of the JPA. For example, commentators noted that it would not be desirable to deploy this tool as a way to subsidise industry to maintain the production of certain medical countermeasures in areas where need is non-existent, or to put pressure on national health policies.

The Belgian representative – Belgium was instrumental in initiating discussions about the JPA mechanism during its 2010 Presidency – also noted that it would be good to create a priority list of medical countermeasures that may be purchased in the future.

The remainder of the workshop focused more closely on pandemic vaccines and discussion included the various available types of marketing authorisation processes in Europe, challenges related to the ‘lessons learned’ on the labelling and packaging of pandemic vaccines and liability issues, e.g. potential side effects of pandemic vaccines such as narcolepsy.

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