The pharmaceutical industry looked forward to the legislative review as an opportunity to resolve long-standing issues, update a 20-year-old regulatory system and adapt it to the goals of future innovations.
But, somewhere along the line, the ambition shifted from perpetuating an outdated regulatory framework to fixing national prerogatives, such as access to and use of medicines, via EU legislation. .
The proposed changes put forward – in addition to the impact of the perma-crisis – risk driving this dynamic industry even further away from Europe.
Improving access to and availability of medicines requires solutions to be developed in partnership with member countries, not an abusive reorientation of EU legislation which forms the basis of an entire European research and development (R&D) for the benefit of its patients.
There is no doubt that the current situation, where patients in one European country do not have access to a given medicine – or have to wait seven times longer – than in another country or region, is untenable and totally unfair. Indeed, all stakeholders, including industry, share the goal of faster and fairer access to medicines for patients across Europe.
EFPIA has already taken concrete steps and developed a series of measures which, taken together, we believe can create a more predictable and timely incremental change in access to medicines for patients across Europe, without harming our competitiveness in life sciences or encroaching on member countries. health competence. *
Any proposal to improve access by linking it to incentives such as intellectual property rights in a review of EU legislation to approve or encourage medicines will be ineffective and unworkable. While intellectual property rights are the sole responsibility of the innovative company, market access is not. Making the former dependent on the latter gets us nowhere, if not less attractive as a region for doing R&D.
And where does that leave the focus on the review of pharmaceutical legislation?
Where it started.
Our industry has two demands from the European Commission:
First of all, the whole industry is relying on the revision of the EU pharmaceutical legislation to achieve exactly this: a first class, 21stregulatory framework of the last century that will help reduce the regulatory burden, accelerate access and make Europe a globally competitive region for medical innovation.
It takes 426 days for the EMA to approve a new active substance, compared to 244 days in the United States, 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 conducted in Europe falling from 29% to 25% over the past 10 years. Currently, many European patients do not benefit from the latest innovative treatments available in Asia and the United States.
EFPIA has four proposals for legislative improvement it could take our current framework to the next level. The industry also proposes eight non-legislative actions that could allow us to improve the competitiveness of our European regulatory system even before the legislation is revised.
Additionally, the world has just emerged from a pandemic, is facing a cost of living crisis, high inflation, an energy crisis and geopolitical turmoil.
Our industry is crucial for European patients and for economic resilience.
Our request is that as lawmakers focus pharmaceutical legislation review on regulatory review to make our region competitive again, we all now commit to working together to find predictable, practical and timely solutions to improve the access to medicines, apart from the examination of legislation.
*In April this year, the industry pledged to file for pricing and reimbursement approval in all 27 member countries within two years of receiving marketing clearance, when local systems allow it, and following this commitment by means of the access portal.
Through the EFPIA Access Portal, the industry will provide greater transparency on manufacturer launches and reimbursement requests at member country level, which will ensure that the root causes of delays can be properly understood and overcome. . Modeling by IQVIA predicts that the industry file commitment would increase drug availability by 18% to 64% in several countries and, most importantly, reduce patient waiting times for new drugs 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 actions which, taken together, will help to tackle inequity of access: Generating evidence; skyline analysis; improving public procurement processes; and implementing new pricing and payment methods, including tiered equity-based pricing reflecting member countries’ ability to pay to help address access, affordability and availability challenges, as well as the correct implementation of the EU regulation on health technology assessment.