Affordability of medicines for patients and health systems in small markets

Priority question for written answer  P-001634/2021
to the Commission
Rule 138
Alex Agius Saliba (S&D)

The single market for pharmaceuticals is currently unbalanced, as the acquis give the industry the right to place their authorised products on the markets of all Member States, while there is no mirroring right entitling the Member States to have access to those products. Price confidentiality clauses also contribute to this imbalance at Member-State level.

The decision to place a product on an individual market is determined by commercial and economic factors. Smaller countries are considered unviable and unattractive, which explains Malta’s strong dependency on the United Kingdom for its supply.

​Through its notice of 25 January 2021, t​he Commission has tried to mitigate the challenges that Malta, Cyprus and Ireland have been facing following Brexit[1]. Yet Malta continues to struggle sourcing essential products.

The European Pillar of Social Rights states that ‘everyone has the right to timely access to affordable, preventive and curative health care of good quality’, which is not possible without access to affordable medicines.

• 1.How does the Commission plan to address the continuity of medicines supply in countries particularly affected by Brexit?
• 2.What immediate and long-term solutions will it provide to address the lack of medicines in smaller markets?
• 3.How does it plan to create a genuine single market for pharmaceuticals to ensure that all EU citizens have equal access to safe and effective medicines through transparent pricing mechanisms?

• [1] Commission Notice of 25 January 2021 entitled ' Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period’ (2021/C 27/08).