EFA has responded to the much-awaited European Commission revision of the EU general pharmaceuticals legislation in December 2021 to ensure allergy and airways diseases patients’ unmet needs are part of the discussion.
EFA welcomes this revision, the first in 20 years, which draws on lessons learnt from the COVID-19 pandemic and calls on stakeholders and members of the public to share their views on matters such as unmet medical needs, incentives for innovation, and the affordability of medicines.
Unequal access to medicines
The health inequalities arising from existing differences in access to medicines are caused by a variety of issues including regulation, pricing, access to medicine, and shortages. For example, regulatory issues can mean the gap between marketing authorisation (which is managed centrally for the EU), and the subsequent steps to reach patients. This can lead to patients having to wait years to access necessary medicines in some parts of Europe even after marketing authorisation has taken place.
At the EU level, action can be taken to improve equal and timely access to medicines. EFA calls for the introduction of joint procurement for critical medicines and for small patient populations, and for the EU to use its influence to improve accessibility and affordability in low- and middle-income countries too.
Unmet medical needs
EFA states that to address unmet medical needs, policymakers must work with a range of patient communities to ensure that policies are patient-centred and to create a common understanding of unmet needs and how to address them. In our response, we highlight the need to update and refine the concept of unmet needs to improve policymaking without restricting the definition and lead to creating gaps for various patient groups.
Incentive for innovation
While more incentives are needed to support innovation, they must also support equitable access to affordable medicines for all patients. As unmet need may arise from different causes, e.g. lack of basic research to understand the disease vs. market failure, different unmet needs will require different incentives. Innovation that brings real added value is only possible with patient involvement, so there should be mechanisms instated for patient involvement in clinical trials, regulation, pricing and reimbursement decisions, and safety monitoring at European and national levels.
Future proofing
As the health, medical and pharmaceutical sectors evolve - patient safety must be at the heart of new initiatives and in policy making. Products development, particularly for rare conditions, should be driven by collaborative processes while regulation needs to facilitate rather than hamper future patient-centric scientific and technological advances. These advances can include gene and personalised therapies, smart health applications, and medical technologies including artificial intelligence. Furthermore, with these developments, definitions such as unmet needs will need to be reviewed for regulation to remain relevant.
EFA also calls for EU legislation to take better into consideration the combination of life-saving medication such as the drug-device combination of adrenaline auto-injectors.
Lessons from the pandemic
The pandemic has highlighted the gaps and challenges in the current pharmaceutical regulatory framework and has shown that the EU must strive for strategic autonomy in pharmaceutical ingredients and incentivise production in the European market. Overall, medicines have great social impact for patients with allergy, asthma, and COPD as they can enable maximum health and protection that patients can achieve. It is therefore paramount that any future measure supports this maximum health objective, equally, across the EU through information standards, regulatory frameworks and collaboration in research.
Moving forward with the pharmaceutical legislation
Embedding “patient value” and “patient involvement” in the new EU legislation is an indispensable starting point for a patient-centred, not profit-centred approach legislation that will support innovation that meets patients’ needs.
Want to know more? Read EFA’s full response to the European Commission consultation on the EU General Pharmaceuticals Legislation.