Increased penetration of generic, biosimilar, and value-added medicines will be critical to enhancing treatment accessibility for patients, while managing the healthcare spend of EU member states. That’s the message from Medicines for Ireland (MFI) to European election candidates in its ‘Manifesto for Europe’ published recently, setting out the association’s key European policy asks.
In its manifesto, MFI is calling for:
- Equitable access to essential medicines through the introduction of pro-competitive measures that ensure early entry of generic, biosimilar, and value-added medicines into the Irish market.
- Safeguarding of Europe’s pharmaceutical production through the adoption of a Critical Medicines Act to bolster manufacturing competitiveness, mitigate supply risks, and support investments in cutting-edge, sustainable manufacturing technologies and workforce upskilling.
- The establishment of a contemporary regulatory framework to keep pace with scientific and technological progress by fast-tracking digital and regulatory efficiency measures within new EU pharmaceutical legislation.
- Promotion of healthcare innovation through the introduction of legislative measures that reward innovation while ensuring affordability.
Commenting, Chair of MFI Mr Paul Neill said: “Access, affordability, and availability are central to our future vision of healthcare in Ireland and must be championed in Europe by our new cohort of Irish MEPs. Pro-competitive measures in EU pharmaceutical and intellectual property legislation need to act as a key enabler to facilitating earlier entry of generic, biosimilar, and value-added medicines in the Irish market. Under the direction of the 10th European Parliament, we urgently need to see EU pharmaceutical laws reformed to drive greater competition, and support investment in affordable off-patent innovation.
“A shift in policy thinking is also required to secure availability of medicines for patients, which is a challenge member states, including Ireland, continue to grapple with,” he continued. “Fostering timely competition and sustainable uptake of generic, biosimilar, and value-added medicines would significantly help shape a future where shortages are an exception rather than the norm. Furthermore, we would like to see the adoption of a Critical Medicines Act to promote open strategic autonomy in healthcare and restore medicines manufacturing competitiveness across Europe. This in turn would reduce dependency risks for essential medicines, also easing pressures on supply.”
Ms Kelly concluded: “In reforming EU pharmaceutical legislation we want the bolar clause exemption to be explicit on facilitating any activities that need to be undertaken to allow generic or biosimilar medicines launch immediately after the expiry of an originator patent. Furthermore, the definition of repurposed medicines needs to be expanded beyond new indicators to include value-added medicines. These issues are of utmost importance for health systems to realise increased value from their medicine spend and to broaden patient access to medicines.”
MFI’s ‘Manifesto for Ireland’ calls align with those made by its European sister association Medicines for Europe (MFE), which will host its 30th Anniversary Annual Conference in Dublin from 12th-13th June. The themes focus on access to medicines, innovation, and sustainable healthcare solutions.
MFI member companies include Accord Healthcare, Celltrion Healthcare, Clonmel Healthcare, Consilient Health, Fannin, Fresenius Kabi, Pinewood Healthcare, Sandoz trading as Rowex, Teva, and Viatris.
