Europe’s planned legislative overhaul is a chance to make our voices count, writes Bernard Mallee
In the coming weeks, the Government will publish a White Paper on Enterprise. It will explore strategic policy options facing the enterprise sector. It comes as the European Commission prepares to publish legislative proposals this year that will reset the operating environment for medicines innovation.
In our submission here to the Department of Enterprise, Trade and Employment ahead of the publication of the White Paper on Enterprise, we urged the Government to protect the conditions for innovation as the basis for better healthcare outcomes, competitiveness, jobs and investments.
Although our economy is strong now, the global outlook is uncertain, especially with inflation, war in Europe and the ongoing impact of Covid-19. Our industry’s footprint is significant – but it must not be taken for granted. Product life cycles, industry consolidation patterns, the draw of emerging markets, skills readiness and sub-optimal speeds of adoption of new medicines in the health services are creating headwinds that could decelerate the pace at which the industry scales into the future.
More partnership and structured dialogue between the State and our industry can yield growth opportunities for the country, as well as identifying risks such as a loss of competitiveness or a diminution in standards of care.
The EU Pharmaceutical Strategy, published by the European Commission about a year ago, will reset the operating environment for medicines innovation, with implications for how medicines are discovered, developed, manufactured and adopted. At stake for Ireland, and for all other EU Member States, are healthcare outcomes, competitiveness, jobs and investments.
We understand that the Regulatory Scrutiny Board recently rejected the Commission’s follow-on draft legislative proposal based on perceived considerable negative implications for the European biopharmaceutical industry. The Commission’s proposals are now expected to be delayed, with adoption likely in the first quarter of next year, subject to Regulatory Scrutiny Board approval.
We hope that Ireland, alongside other countries with a deep biopharmaceutical manufacturing footprint, can be a strong voice in favour of innovation as the catalyst for new medicines, cures and vaccines, and the jobs and investments that go with them. In the past 20 years, hundreds of new orphan and paediatric medicines have emerged as a result of stable IP rights. It is vital that we protect these rights.
Equitable access to medicines for all of Europe’s citizens is a European Commission priority. It is for our industry, too. We are bringing forward proposals at European policy level to support improved access, even as national health systems remain key. By contrast, suggestions that medicines access and availability can be improved by weakening European IP rights are incorrect. Weakening IP rights principally dilutes the incentive to invest in the discovery and production of innovative medicines in the first place.
Our industry is not against a reform of the pharmaceutical legislation. We have outlined to the Commission and to MEPs proposals which can future-proof the operating environment for innovation. These proposals include:
- Refinements in IP rights for orphan and paediatric medicines through modulations in the market exclusivity periods so that we can continue to tackle unmet medical needs.
- A commitment to providing timely information about the filing of medicines reimbursement applications in the EU27 using a real-time online portal that improves traceability and transparency.
- A commitment to filing reimbursement applications in all Member States within two years of a medicine’s central EU market authorisation.
- A pricing framework, known as equity-based tiered pricing, that assures less well-off Member States that they are getting value for medicines appropriate to their economic circumstances.
- A ‘pull’ incentive to stimulate anti-microbial research, building on a recent announcement by the industry of almost €1 billion for antibiotic development.
These steps would, we believe, position Ireland for growth in the globally traded biopharmaceutical industry. The wrong policy moves could set that project back and erode our competitiveness, both in clinical outcomes and in investment decision-making. Let’s make our voice count in Europe.
Bernard Mallee is Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association.
