An EU Pharma Policy Framework for Better Access to Affordable Medicines

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The new president of Medicines for Europe, Elisabeth Stampa, outlines one of the priorities of her mandate: working to adjust the EU pharma policy framework to improve access for patients across Europe. 

Regulatory flexibilities implemented during COVID-19 showed that the EU system can require one of highest safety, quality and efficacy standards but could at the same time be adapted to allow medicines to flow freely to where they were needed most.

The off-patent medicines industry provides close to 70% of dispensed medicines in Europe. Our sector is the foundation of public health security and population wellbeing and key to sustaining healthcare systems in Europe.

It is my pleasure to lead Medicines for Europe, the off-patent medicines trade association, through some of the biggest challenges that our sector faces. Together with our community of members, industry leaders, national associations, and colleagues, we are ready with the solutions to deliver better, more equitable access to health for European patients.

The pandemic has shone a light on the off-patent pharmaceutical sector and some critical points have risen to the top of the political agenda. My starting point is that a sustainable medicines manufacturing sector and supply chains matter to EU pharmaceutical security. The increased awareness of the dependency on supplies from other territories due to industry consolidation has come to the fore in public discourse. Medicine shortages and the resilience of pharma supply chains have become high level political concerns in the EU. The EU should support manufacturing with workable incentives like access to EU recovery funds and similar mechanisms.

Now recovering from a pandemic, governments are deeply in debt and concerned about the cost of healthcare and pharmaceuticals. There is rightly a strong focus in EU policies on increasing generic and biosimilar medicines uptake and encouraging competition. However, that is not aligned with the intense pressure from cost-containment-only measures in generic medicines procurement and pricing policies at national level. These increase the risk of shortages and hamper patient access to medicines and could therefore be regarded as short-sighted. We must shift to policies that encourage healthy competition, so that we can offer sustained benefits and adapt to rapidly evolving realities, like sky high inflation rates and extraordinary threats like the pandemic or the war in Ukraine. There is a false belief that if new obligations and regulatory requirements are introduced (such as stockpiling or high fines) supply chain responsiveness will be strengthened. Decision-makers should be careful and evaluate the impact and unintended shortage consequences that such measures can create. We have seen during the pandemic that increased stockpiling among member states created supply chain bottlenecks and prevented companies from sending medicines to where they were most needed by patients.

Like many sectors, the pharmaceutical sector is assessing how to reduce its environmental footprint. We understand the need to contribute in a positive way by addressing medical waste, wastewater management and embracing the circular economy. We will continue our commitment to fight antimicrobial resistance, while maintaining patient access to essential antibiotics where they are medically necessary. We should also quickly re-think some of the unnecessary paperwork and administrative burden that goes in to supplying medicines. We continue to support the transition to electronic product information (EPI). This would replace the paper leaflet in each box of medicines, providing access to a digital version, and bring benefits to the patient like adapted font size for readability, search for key words, and better equip patients and healthcare professionals with the latest information on safety profiles and side effects. This would drastically reduce the use of paper in the provision of medicines and improve the environmental footprint of companies and individuals.

Much work remains to be done to modernise the EU medicines regulatory network. Regulatory flexibilities implemented during COVID-19 showed that the EU system can require one of highest safety, quality and efficacy standards but could at the same time be adapted to allow medicines to flow freely to where they were needed most. This degree of high operationalisation should not be confined to a time of emergency. Regulatory reform is needed across the sector, including digitalising and interconnecting the agencies’ networks.

Finally, I would like to see an adjustment of the IP framework, so that it enhances innovation and encourages healthy competition. We firmly oppose efforts to evergreen IP and artificially extend monopolistic positions on the market. With both the EU Pharmaceutical strategy and the Intellectual Property Action plan of the EU upcoming, there is an opportunity to tackle some of the worst evergreening abuses which lead to limited and delayed access to off-patent medicines for the patient. We will advocate for bolar harmonisation and enlargement. We will address the low quality of many patents issued by the European Patent Office and the misuse of divisional patent cascades. We will continue to press for the removal of “unlawful” (according to the European Commission) patent linkage systems and support a smooth and full implementation of the SPC manufacturing waiver in July 2022 to create jobs and growth for Europe and better patient access to EU manufactured medicines.

I expect my Presidency mandate of Medicines for Europe to be a busy one and at the same time a successful one for European patients and the European off-patent sector.


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