As the past 2 years have been dominated by COVID-19, the upcoming revision of the EU pharmaceutical legislation could not come at a more critical time.
The pandemic increased the relevance and power of the pharmaceutical industry as a key provider of vaccines and therapies. Yet, COVID-19 has also revealed important weak spots. The negotiation of contracts with vaccine manufacturers put the lack of transparency around pharmaceutical prices and costs in the spotlight. And even though industry received massive public funding, global access to vaccines and therapies remains out of reach.
The revision of the EU pharmaceutical legislation should be a turning point. The EU should not lose sight of the 3 key aims of pharmaceutical laws and policies: (1) to ensure timely and affordable access to safe and effective medicines; (2) to spur meaningful, needs-driven, patient as opposed to drug-centric innovation, and (3) to contribute to sustainable health systems, an essential pillar of a fairer and more inclusive European Union. Achieving these objectives, and especially a balance between innovation incentives and access to affordable medicines are not easy tasks. However, the success of the ambitious Pharmaceutical Strategy for Europe, depends on this.
In its response to the open public consultation, EPHA highlighted critical aspects for the forthcoming revision of the pharmaceutical legislation:
- The generation of further safety and quality information, including comparative data on the benefits and harms of new drugs and high-risk devices both before and after their market entry, should be facilitated and incentivised.
- As shortages of drugs need to be increasingly addressed, the possibility of compounding, which allows hospital pharmacists to deal with some important shortages, should not be precluded.
- The problem of unequal access to centrally authorized medicines not marketed in many EU countries should be tackled. Access to medicines (and the lives of patients depending on them) cannot be left to the commercial decisions of private companies.
- The added value of new medicines as well as their impact on national healthcare budgets needs to be systematically evaluated.
- As incentives are provided for medicines addressing “unmet medical needs,” the quality of life of patients and broader societal concerns should be amongst the criteria required to categorize medicines receiving additional incentives.
- Different pharmaceutical incentives and exclusivities require further fine tuning. It will be critical to steer innovation where it is needed. Pharma incentives should be dependent on transparent reporting of R&D costs considering that EU patients already pay the R&D costs through taxes.
- Generics and biosimilars should be allowed into the market right after the protection periods are over and any attempt of hampering this should be punished.
- The authorization of treatments developed in academic settings for non-commercial purposes should be facilitated.
- As the EU reflects on further strategies to address the lack of innovation for new antibiotics, and the increasing challenge of antimicrobial resistance (AMR), it is important that incentives and exclusivities that have failed elsewhere are not replicated.
- The current regulatory system has contributed to guaranteeing the safety, efficacy, and quality of pharmaceutical products. It has also proven to be flexible enough, for instance, to allow the extremely fast approval of medicines and vaccines during the current pandemic. Therefore, new loopholes such as expedited approval pathways should be dealt with caution.
Each of these aspects, and many others highlighted in our response, deserve further attention and the input of all involved stakeholders.