Europe

The pharmaceutical legislation is a once-in-a-generation opportunity: let’s make sure the focus is right

The pharmaceutical industry had been looking forward to the revision of legislation as an opportunity to fix long-standing problems, update a 20-year-old regulatory system and make it fit for purpose for the innovations of the future.

But, somewhere along the line, the ambition moved from futureproofing an outdated regulatory framework to fixing national prerogatives, such as access and uptake of medicines, via EU legislation.  

The proposed changes being put forward — on top of the impact of the perma-crisis — risk alienating this dynamic industry from Europe even further.

The proposed changes being put forward — on top of the impact of the perma-crisis — risk alienating this dynamic industry from Europe even further.

Improving access and availability of medicines requires solutions to be developed in partnership with member countries, not ill-repurposing of the EU legislation that provides the basis for an entire European research and development (R&D) ecosystem for the benefit of its patients.

It is beyond doubt that the current situation, where patients in one European country do not have access to — or have to wait seven times longer for — a given medicine than in another country or region is untenable, and grossly unfair. Indeed, all stakeholders including the industry share the goal of faster, more equitable access to medicines for patients across Europe.

EFPIA has already taken concrete action and developed a raft of measures that, as a package, we believe can create a more predictable and timely step change in access to medicines for patients across Europe, without harming our life-science competitiveness or impinging on member countries’ health competence. *

Any proposal to try to improve access by linking it to incentives such as intellectual property rights in a review of EU legislation aimed at approving or incentivizing medicinal products, will be ineffective and unworkable. While intellectual property rights are the sole responsibility of the innovative company, access to market is not.  Making the former dependent on the latter leads us nowhere, except less attractive as a region to do R&D. 

And where does that leave the pharmaceutical legislative review focus?

Right back where it started.

Our industry has two requests of the European Commission: 

First, the entire industry is relying on the EU pharma legislative review delivering just that: a first-class, 21st-century regulatory framework that will help reduce regulatory burden, speed up access and ensure Europe is a globally competitive region for medical innovation. 

Our industry is crucial to Europe’s patients and to economic resilience.

It takes the EMA 426 days to approve a new active substance, compared to 244 days in the U.S., 306 in Canada, 313 in Japan or 315 in Australia. This means that Europe has become less attractive to developers, with the percentage of global clinical trials being carried out in Europe declining from 29 percent to 25 percent over the past 10 years. Right now, many European patients miss out on the latest innovative treatments that are available in Asia and the U.S.

EFPIA has four proposals for legislative improvement that could take our current framework to the next level. The industry also proposes eight nonlegislative actions that could ensure we improve the competitiveness of our EU regulatory system even before the legislation is revised. 

Furthermore, the world has recently emerged from a pandemic, is dealing with a cost-of-living crisis, high inflation, an energy crisis and geopolitical turmoil.

Our industry is crucial to Europe’s patients and to economic resilience.  

Our request is that while legislators focus the revision of the pharma legislation on the regulatory review to make our region competitive again, we all commit now, to working together to find predictable, practical and timely solutions to improving access to medicines, outside of the review of legislation. 


* In April of this year, industry committed to file for pricing and reimbursement approval in all 27 member countries within two years of receiving marketing authorization, where local systems allow, and following that commitment by means of the Access Portal. 

Through EFPIA’s Access Portal,industry will provide greater transparency on manufacturers’ launches and reimbursement applications at member country level, which will ensure that the root causes of delays can be properly understood and overcome. Modelling by IQVIA predicts that the industry’s commitment to file would increase the availability of medicines from 18 percent up to 64 percent in several countries and critically, reduce the time patients wait for new medicines by four-to-five months in countries such as Bulgaria (-179 days), Poland (-129 days) and Romania (-155 days).  

The above access actions are supported by a series of other measures, which if taken together will help address inequality of access: Evidence generation; horizon scanning; improved public procurement processes; and the implementation of novel pricing and payment methods, including equity-based tiered pricing reflecting member country ability to pay to help address access, affordability and availability challenges, as well as the correct implementation of the EU Health Technology Assessment regulation.  




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