‘I am very concerned with this situation’ – PM Robert Abela calls for EU medicine reform

Malta’s Prime Minister Robert Abela has written to the European Council requesting a review of the EU’s pharmaceutical market, it was revealed on Monday.

In his letter to the European Council President Charles Michel, acquired by Politico, Dr Abela revealed that “with the United Kingdom’s departure from the EU, Malta has lost its main legal vehicle to supply medicinal products to its patients”.

In light of this, he sees a need to reform the pharmaceutical market, saying he is “very concerned with [the situation] since shortages of medicinal products will undermine the effectiveness of [Malta’s] healthcare system”.

The problem is that, as things stand, whilst the EU is able to approve medicines for all its member nations’ markets, those medicines are currently not necessarily made available for acquisition by all member states.

In the words of Dr Abela, “access to pharmaceuticals is dependent on the financial viability of the pharmaceutical product on the market of each Member State”, which has led to a “long-standing structural problem, particularly for smaller Member States”. 

In the future, he proposes that “access should not continue to be driven by market forces,” and that instead, “a more balanced approach is required, through which the public health dimension of medicinal products is given more prominence”.

“The industry’s current right to place products on the markets of all 27 Member States of the European Union should be mirrored by empowering all 27 member states to get access to the products placed on the EU Single Market”, he writes.

Detailing how this would look, he envisions “the introduction of an obligation on the industry to place products on the Market of all Member States within a reasonable time, once a product is marketed in a single Member State”.

Dr Abela writes that whilst Malta may accept price discrimination, this should be through a transparent and fair mechanism. 

Furthermore, he indicates that Malta “would favourably consider more joint procurement initiatives at EU level, led by the Commission, for certain categories of products,” and reveals that he has written to European Commission President von der Leyen to call for “concrete action” with regards to this. 

In the letter, the Prime Minister also proclaims the EU vaccine strategy as a “success story which provides “tangible benefits to all [the EU’s] citizens.”

Dr Abela believes that his proposed changes would remain in line with the European Council’s commitment to further integration in the Single Market, by addressing “fragmentation, barriers and weaknesses”, thus sending “tangible messages to our citizens about [the bloc’s] commitment to strengthening the resilience of [its] health systems”.

Whilst the issue may be contentious, Dr Abela believes that “addressing the problems that [the bloc has] internally will also give [it] more credibility as a Union on the international stage and within multilateral fora”.