In September 2021, we posted about the European Commission's implementation of its new pharmaceutical strategy (which was also discussed in more detail in our posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response). Readers will be aware that the focus of the Strategy is on the availability, accessibility and affordability of medicinal products, based on the view that current incentive models do not provide an adequate solution for unmet medical needs or appropriately incentivise investment in innovation. As part of its work on the revision of the EU pharmaceutical legislation, the European Commission launched a public consultation to seek views on the current framework and on some of the proposals for changes in order to support the European Commission's impact assessment for the revision of the legislation.
Following this consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published an article entitled "Back Innovation, Boost Access" with its response to the EU pharmaceutical strategy consultations and some of the concerns raised by the Commission. This expresses EFPIA's position that innovation is only meaningful if patients have access to it, but highlights that access is not always in the control of the pharmaceutical companies. It also describes the current status of access to medicines in the EU Member States, some of the reasons for the delays to access and EFPIA's proposals to improve patient access to innovative medicines.
Access to medicines in EU
The EFPIA article sets out the situation of access to medicines in the EU Member States and highlights that millions of people across Europe may not always have access to the scientific breakthroughs in medicines when they need them. The article provides a link to the EFPIA Patients W.A.I.T. Indicator 2021 Survey, which shows that despite targets set out in EU legislation of 180 days, the time between approval of a medicine and when it reaches patients varies significantly across Europe. For example, 133 days in Germany versus 899 days in Romania.
Indeed, patients in Northern and Western Europe generally gain access to new medicines between 100 and 350 days after grant of the marketing authorisation (MA), but for patients in Southern and Eastern Europe, it can take between 600 and 850 days after grant of the MA before a medicine becomes available. This is clearly unsatisfactory for patients, and is understandably an area the Commission is seeking to address.
The issues regarding delays to access
EFPIA notes that there are many reasons for the delays of access to medicines. A recent analysis by EFPIA, covering the root cause of the unavailability and delay to innovative medicines, sets out 10 interrelated factors that cause delays to access, including:
- slow regulatory processes
- late initiation of market access assessment
- duplicative evidence requirements
- reimbursement delays
- local formulary decisions
The range of the issues covered in the analysis highlights that one stakeholder alone (e.g., competent authorities, payors, industry) cannot fix all of these identified issues, and indeed cannot solely be addressed by changes to the legislation, as proposed by the Commission. EFPIA therefore supports a multi-stakeholder approach to explore a range of initiatives, including:
- a process that would better align value and ability to pay
- more efficient value assessments of new vaccines
- as well as proposals to ensure solidarity across EU Member States
Bringing innovative solutions
As part of the approach, EFPIA members have made a number of commitments in relation to market access:
- In order to accelerate patient access to medicines, EFPIA members have committed to file for pricing and reimbursement (P&R) as soon as possible and in any case within two years after grant of MA in the EU (as set out in EFPIA's publication Addressing patient access inequalities in Europe).
- To assist with transparency of the process, information on the timing and processing of P&R applications across the 27 EU Member States will be systematically collected on a dedicated portal, with the aim of increasing transparency around market launches and gaining a better understanding of the kinds of solutions stakeholders need to develop to overcome key obstacles to access.
- With regards to the affordability of medicines, the pharmaceutical industry proposes a new pricing structure to address related barriers. For example, EFPIA's proposal for an Equity-Based Tiered Pricing framework seeks to ensure that the price countries pay for medicines reflects their ability to pay for them.
While EFPIA can control proposals 1 and 2, in relation to 3, EFPIA highlights that, in order for changes to payment structures to be put in place, the European Commission and EU Member States will need to amend external reference pricing systems. In practice, however, the European Commission can only have a limited role in such amendments as pricing of medicinal products is a domain of national competence for the EU Member States.
Further, the position of EFPIA is that the EU internal market rules need to be adapted to prevent parallel trade (i.e., the practice of buying medicines at lower prices in certain countries and selling them in markets where they can ask for a higher price). This will enable companies to offer different prices across the EU and meet local needs.
The article also highlights EFPIA and its members' proposal for a greater move towards novel pricing and payment models to make it easier for EU Member States to introduce highly innovative medicines, including cell and gene therapies. EFPIA acknowledges that, while the potential clinical benefits of these new therapies are significant, limited datasets and a lack of long-term experience with these therapies are inconsistent with the current reimbursement systems in the EU Member States.
The EFPIA article sets out ways that these challenges could be overcome through greater use of outcomes-based payment models and subscription models, as well as supporting sustainability by paying for medicines over time. It makes clear that more flexible pricing solutions would allow decision makers to manage uncertainty around long-term outcomes, while at the same time providing quick access to lifechanging and lifesaving medicines.
Next steps
The proposals are of course only proposals from EFPIA members, and do not directly feed into the legislative process or Commission consultation. However, the hope of industry is that such concrete measures will address some of the concerns and mean that some of the more drastic changes to legislation, which industry believe could be detrimental to research and development and to innovation, are not introduced in their current form.
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