The European Parliament on 16th February 2022 passed a resolution on “strengthening Europe in the fight against cancer” which includes recommendations for proposed reforms to the market access (including pricing) landscape designed to ensure equal access to cancer care and medicines in the European Union (EU).
The key recommendations set out in the resolution and impacting on market access include:
- Promote the use of off-patent medicines and biosimilars by removing barriers to competition, for example by banning intellectual property evergreening practices and patent linkage.
- Encourage the use of joint clinical assessments of medicines carried out under the Health Technology Assessment regulation
- Invite member states to consider joint price negotiations with pharmaceutical companies (eg as carried out under the BeNeLuxA initiative or the Valletta Declaration)
- Make “fair pricing and affordability of new treatments a core element of the Plan [Europe’s Beating Cancer Plan] and the Pharmaceutical Strategy for Europe, notably by attaching conditionalities to EU public funding” and ensure that medicines resulting from publicly funded research are available at “fair and affordable prices”, including medicines benefiting from “specific regulatory or market protection” eg those to treat rare or paediatric cancers
- Increase transparency, especially regarding “pricing components, reimbursement criteria and the actual (net) prices of medicines in different member states”
- Extend joint procurement to (ultra) rare, paediatric and novel cancer medicines and treatments, diagnostic procedures, companion diagnostics, and cancer-preventing vaccines
- Strengthen incentives for rare cancer treatments
- Revise Council Directive 89/105/EEC on the transparency of measures regulating the prices of medicinal products “in order to ensure effective controls and full transparency of the procedures used to determine the price of and reimbursement amount for medicines, in particular cancer medicines, in Member States”
- Encourage regulatory authorities to ask pharmaceutical manufacturers for information on research and development (R&D) costs, including public financing, prior to marketing authorisation as well as on any tax benefits and subsidies they have received. Consider the use of public funding in calculating drug costs.
- Encourage Member States to develop personalised medicines through “cooperation among them” and promote the use of regional molecular genetics platforms. Ensure that the classification of cancers based on specific genotypes does not lead to the creation of “artificial rare diseases” with the aim of increasing financial compensation.
- Facilitate the development of gender-based treatments for cancer
- Encourage a more sustainable environment for conducting research into and analysing existing research about the repurposing of medicines for cancer treatment. Create “an additional project that uses high-performance computing to rapidly test existing molecules and new drug combinations, starting with high unmet needs”
- Create a pharmaceutical legislative framework for oncology medicines that promotes “real breakthrough innovations and not the so-called ‘me-too’ pharmaceuticals”. The document also calls for “a large consortium of public authorities, private companies and NGOs […] to work together to guarantee the accessibility and affordability of cancer treatment options requiring complex technologies, for instance, complex treatments like cell therapy (CAR T cells), gene therapy, adoptive immunotherapy through the use of tumour genome extracts (messenger RNA) and nanotechnologies”.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) broadly welcomed the recommendations. However, it also raised concerns, specifically:
- With regards disclosing net prices, EFPIA argues that this “removes the flexibility for companies to adapt the price of a medicine to a Member State’s economic and healthcare settings”
- Whilst EFPIA recognises that information on the R&D process and costs can be important, “it must be noted that estimates of R&D expenditure are not helpful for determining the appropriate pricing of medicines”
- Joint procurement, meanwhile, is “not a solution for more sustainable supplies of and improved access to vaccines and innovative medicines in Europe”.
www.europarl.europa.eu, “European Parliament resolution of 16 February 2022 on strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy”, 16 February 2022
www.efpia.eu, “EFPIA Statement on the Special Committee on Beating Cancer (BECA) report”, 16 February 2022