The European Commission recently published a public consultation on the revision of the EU’s Pharmaceutical Strategy, which will run until 21 December, 2021. All diabetes national associations and individual stakeholders are encouraged to contribute to the future regulatory framework for pharmaceuticals and share their expertise on how to best address the unmet needs of people living with diabetes relating to access to medicines, technologies and care.
This consultation is the final stage of public consultation on the proposed revised European Pharmaceutical Strategy. The feedback on the roadmap/inception impact assessment for the revision of pharmaceutical legislation closed in April, 2021. The legislative proposal is planned to be adopted in Q4 2022.
For the diabetes community, one of the most relevant focus areas of the proposed revised strategy is the ambition to ensure access to affordable medicines and address unmet medical needs for all. To achieve these goals, the Commission aims to invest in the competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and unite all stakeholders to create a person-centred and value-based approach to care.
IDF Europe supports the Strategy’s objectives to reduce inequalities in access to affordable medicines for patients across the EU and within Member States (MS), which have become even more apparent during the COVID-19 crisis. We also commend the goals of addressing unmet medical needs, which are present across many conditions, and promoting the adoption of new innovative tools, treatments and technologies to reduce health expenditure and improve care. Critical to the achievement of these goals are:
• Recognising the need and benefits of placing citizens at the centre of all decisions and to ensure comprehensive and meaningful engagement. People living with diabetes and other conditions have a key role to play not only in helping fast-track the adoption of medicines and technologies addressing unmet needs but also in identifying priority research and development areas and, most importantly, in defining the criteria by which the value of a particular medicine or technology can be assessed, taking into account the outcomes that matter most to them.
• Simplifying the legislation and creating regulatory attractiveness as well as revising the system of incentives. Marketing authorisation procedures should follow similar processes and scientific evidence across all Member States and all medicines benefiting from a central marketing authorisation, linked to a specific incentive or not, should be made available in all MS.
• Promoting greater competition, especially relating to the introduction of generics and biosimilars, which can afford a significant financial benefit to patients and healthcare systems. In doing so, it will be important not to lose sight of the fact that product substitution must only take place with people and healthcare professionals’ informed consent and with full and transparent access to all relevant data supporting mode of action, efficiency, dosages, and other relevant data compared with the reference product.
To visit our full response to the roadmap consultation on the evaluation and revision of the general pharmaceutical legislation, please, go here.