A leading Irish pharma body, Medicines for Ireland, which represents the generics industry here, with members such as Mylan, Teva, Pinewood, Clonmel Healthcare, met with MEPs on Tuesday to discuss the current Commission proposal to amend the Supplementary Protection Certificate regulations (SPC) which forces the European generic and biosimilar medicines industry to transfer production outside of Europe.

Currently, pharmaceutical companies with patent protected medicines enjoy protection from competition through an SPC. An SPC can afford the holder additional patent protection for up to 5 years.

Under the Commission’s proposal published on 28 May last, the Commission wants to introduce an ‘export manufacturing waiver’ across the EU to allow pharmaceutical companies to manufacture and export medicines to countries outside the EU, where the patent has already fallen.

Given the size and scale of the pharmaceutical industry in Ireland if this proposal delivers its full potential, Ireland and many other European countries stand to gain a significant amount of inward investment in employment and R&D.

Independent analysis, shows that reform of the current SPC regulation has the potential to create up to 25,000 additional manufacturing jobs in the sector across Europe, with Ireland well positioned to secure many of these jobs.

With minor amendments to the Commission’s current proposal, this development could also result in more Day 1 launches, yielding quicker patient access to medicines, earlier treatment for patients and huge savings for the HSE and other European health systems, in addition to shorter, safer supply chains in Europe.

The proposal for an SPC manufacturing waiver has undergone a very rigorous assessment process starting with the Single Market Strategy, an impact assessment and several independent studies e.g. by Charles Rivers Associates and the Max Planck Institute.

Tuesday’s event took place in the European Parliament hosted by Medicines for Europe, the European-wide representative body for the generics industry across the EU and was organised to mobilise MEPs, including Ireland’s, to back the European Commission reform proposal.

Currently, European-based manufactures are protected from competition inside and outside the EU, even where the patent has expired.

The Commission’s current proposal for a waiver will only allow European based medicine manufacturers to commence production and supply of these medicines to countries outside the EU, once a patent expires.

However, Europe’s generics industry argues that its sector should also be permitted to manufacture for countries within Europe, so that patients can access more affordable medicines from the first day on which patent protection ends in Europe.  The current delay on medicine manufacturing until after patent expiry stifles industry R&D, facility expansion and recruitment.

This week’s event in the European Parliament brought together a range of stakeholders who are supportive of the waiver proposal, including officials from European Commissioner for Internal Market, Industry and Entrepreneurship Elizbieta Bienkowska’s office, the Director General of Medicines for Europe Adrian van den Hoven, representatives from the pharma manufacturing, ingredients sector and medicine regulatory sector. Medicines for Ireland were represented by the organisation’s Vice-Chairman David Delaney. Irish MEP Sean Kelly, leader of the Irish EPP Group in the Parliament attended, discussed the proposals and impact for Ireland with stakeholders.

The proposal will require the support of both the European Council and European Parliament. However, the process moved a step further last Friday (22 June) when six Member States – Slovakia, Poland, Portugal, Romania, Greece and Italy, joined Hungary in voicing their support for the waiver proposal. Ireland has yet to set out its position, notwithstanding the opportunity for Ireland from such reforms.

Commenting on the event and the proposal itself, David Delaney, Vice-Chairman Medicines for Ireland and European Director Policy & Market Access Mylan, commented: “I am met with MEPs and other relevant stakeholders this week because Medicines for Ireland recognises the value of this proposal for the pharma sector here. If this waiver is introduced properly there is a massive opportunity to grow our sector further.

There will be tens of thousands of jobs up for grabs. Ireland can and must be in pole position for these jobs. As a country we have already proven our ability to be a global leader in pharma and Medicines for Ireland want to see our existing footprint expand. With high-end jobs with a significant research and development component, this reform represents a huge opportunity for Ireland, so I would encourage all stakeholders to support this proposal”.

“For patients this reform will result in a more competitive medicines market, drive greater earlier and access to medicines in Europe not just outside Europe, with locally produced medicines, and spur on the development of more affordable generic and biosimilar medicines  across Europe,” added Mr. Delaney.