IDF Europe, a pan-European, not-for-profit organisation representing people living with diabetes (PwD) and healthcare professionals (HCPs) in 70 member associations across 44 countries in Europe, welcomes the opportunity to respond to the evaluation and revision of the general pharmaceutical legislation.
We strongly support the objectives of reducing inequalities in access to affordable medicines for patients across the EU and within Member States, which have become even more apparent during the COVID-19 crisis. For many of the 32 million PwD in the European Union (one in 10 adults), access to care and medicines often comes at a cost or is a reflection of where they live. We also commend the goals of addressing unmet medical needs, which are present across many conditions, and enabling innovation. A pre-requisite to ensuring optimal health outcomes for PwD and many other conditions is, indeed, to guarantee uninterrupted access to the required, affordable medicines (and care) throughout their life course.
Critical to the achievement of these goals will be to recognise 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. Where appropriate, greater usage of real-world evidence should be promoted. The concept of patient-centred, value- and outcomes-based decision-making must be embedded in health technology assessment processes and in discussions surrounding pricing and reimbursement. There needs to be less duplication of efforts and more consistency of assessment across Europe to ensure that all approved medicines reach all European citizens at the same time. People living with conditions and associated co-morbidities must also be engaged as equal partners in reaching a common understanding of unmet needs.
The principles of ensuring equal and affordable access for all citizens in the Union should also underpin the simplification of legislation and the creation of regulatory attractiveness as well as the revision of 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 Member States. A critical component to fostering innovation while promoting affordable access ultimately relies on greater collaboration, coordination, and transparency (e.g., pricing decisions, benefits of medicines, etc.) between all stakeholders including patients, governments, healthcare systems, the private sector and others, and should also cover improvements in procurement mechanisms and the logistics chain.
IDF Europe agrees with the need to promote 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.
The COVID-19 crisis has brought to the fore the necessity of a strong, collaborative and united approach to health within the Union. We urge all stakeholders to contribute to a robust and ambitious framework for pharmaceutical regulation that increases the value of cooperation, puts European citizens’ needs at the forefront, and guarantees truly equitable access to medicines and care across Europe.
IDF Europe is committed to improving the lives of people with diabetes and would welcome the opportunity of working closely with the European Commission and providing further input and feedback on the pharmaceutical legislation in subsequent consultations.
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