EFPIA statement on the WHO/Europe Tel Aviv ministerial lunch 12 September 2022
The research-based pharmaceutical industry operating in Europe, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), shares the vision of the WHO/Europe Oslo Medicines Initiative (OMI) to improve the access to novel therapies for patients in Europe and reduce access inequalities, and has therefore engaged in close dialogue with the OMI from its inception in 2020.
The last few decades have seen consecutive waves of breakthrough and patient-centered therapeutic innovations being developed and launched by the industry in areas such as cancer, HIV/AIDS, immunological conditions, rare and genetic diseases, hepatitis C and most recently COVID-19, improving healthcare and changing the lives of patients throughout Europe. During this time, despite all these and other innovations coming to market and creating benefits for patients, health systems and societies, pharmaceutical expenditure has remained stable as a share of total healthcare expenditure in most European countries.
At the same time, the introduction of more specialized and targeted therapies, many administered in hospitals or specialized centres, including cell- and gene therapies and medicines for rare diseases, have created new types of challenges for healthcare delivery and financing, value assessment and pricing & reimbursement. There are also concerning inequalities between European countries in terms of availability as well as time from market authorization to launch and effective use of innovative medicines by patients. Another concerning trend has been the gradual but steady decline of Europe as a preferred region for investment in medical R&D, with other countries and regions including the US and China being more successful in attracting these investments. This has consequences for patients as well as the whole innovation eco-system in Europe.
The root causes of unavailability and access delays are multi-factorial, stemming from the interactions of factors such as specificities of national pricing and reimbursement systems (including unintended consequences of External Reference Pricing), misalignment regarding evidence requirements, value and/or price between payers and manufacturers, local capacity of healthcare delivery and diagnosis, and level of healthcare financing in different countries and regions, and how pharmaceutical companies react and adapt to these and other factors when launching products on different markets. Challenges relating to access, pricing and reimbursement therefore vary significantly between different countries as well as between different therapy areas and classes of medicines. For this reason, different solutions are needed to address different problems.
In this context, the industry welcomes the proposed next step of the initiative, to set up a multi-stakeholder platform between Member States and all relevant stakeholders including the industry, to promote constructive dialogue and identify challenges and solutions. As set out in the WHO/Europe statement on the Oslo Medicines Initiative, these could for example concern joint initiatives on horizon scanning to support health system planning and preparation for new innovation, evidence generation post market launch to support healthcare decision-making, value assessment and pricing & reimbursement, the effectiveness of public procurement, and implementation of novel pricing and payment models, including to address challenges relating to advanced therapies.
Examples of initiatives that have recently been proposed by the industry and which could be further discussed in such a forum includes:
- A commitment to file for pricing and reimbursement in all EU countries no later than 2 years after central market authorization;
- A European Access Portal to monitor progress and identify access barriers;
- A pragmatic framework for Equity-Based Tiered Pricing to reduce access inequalities between different countries.
- A white paper on the effective use of public procurement of medicines in the EU.
In line with the core principle of sustainability, the solutions should aim to both ensure the long-term sustainability and performance of European health systems to maximise health outcomes for people and patients as well as the sustainability of the industry to ensure continued investment in Research and Development for the benefit of patients with unmet medical needs. The coordination with other relevant initiatives, including the implementation of the EU Pharmaceutical Strategy, is in this context also welcomed in order to ensure synergies and avoid misalignment of objectives and actions.
EFPIA and its members are looking forward to the continued dialogue and collaboration with WHO/Europe and its Member States and all other stakeholders to achieve our common vision of a Europe where all patients can get access to the healthcare they need today, and scientific progress continues unabated to improve the lives of people and patients tomorrow.