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EU Pharma strategy provides unique moment to establish a regulatory pathway for Value Added Medicines and level the playing field with US

The absence of a cohesive and unique regulatory framework for value added medicines in Europe acts to the detriment of patients and health care professionals across the continent. Gaps in the pharmaceutical legislation must be addressed to support off-patent innovation.

The outbreak of COVID-19 in Europe highlighted the urgency to support value added medicines. Off-patent, repurposed medicines are among the few treatment options for critically ill COVID patients. Successful repurposing provided access to affordable medicines such as dexamethasone to reduce fatalities in hospitalised COVID-19 patients. Value added innovation also optimised healthcare resources by offering formulations of medicines that enabled patients to receive appropriate care at home, while not being exposed to the risk of contracting COVID-19, thereby relieving much needed hospital resources.

Value added innovation brings meaningful improvements to off-patent medicines for patients by applying modern science and technology to well-established molecules.  It is affordable and sustainable. Yet the absence of a designated pathway for these medicines in Europe discourages their development. This is in stark contrast to the US system, which has a clear framework to support patient centred innovation. Our policy framework must catch up and support continuous innovation on off-patent medicines.

Medicines for Europe has launched a series of concrete recommendations to support value added medicines. The report (available here) sets three requirements for value added innovation in Europe. These are:

• Design a fit for purpose regulatory framework that will enable clarity early in the development
• Recognise value added medicines as a category of innovation with proportionate incentives
• Recognise and define value for health care systems

The Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan (Viatris) commented “Europe drastically lags behind the United States in terms of supporting value added medicines. The US has recognised the importance of off-patent innovation for the most challenging chronic diseases like cancer, respiratory conditions and antimicrobial resistance. Rather than stifling this innovation, the US has facilitated it with a dedicated regulatory pathway. Today, we are launching our recommendations to put Europe at the centre of continuous innovation on off-patent medicines by creating a fit for purpose legal framework under the EU Pharma Strategy.”

Medicines for Europe President Christoph Stoller (Teva) added “Never has the importance of value added medicines been more evident than during COVID-19. Off-patent medicines were investigated and scientifically validated for new indications so that they could be used on critically ill COVID-19 patients and continue to be one of the very few lifelines for hospitals. Additionally, the significant impact of the pandemic on non-COVID-19 patients cannot be underestimated and has demonstrated the need for a shift toward home care delivery, which can be supported by the combination of known molecules with digital technologies. Europe must develop a framework that supports this kind of innovation in the off-patent sector for all patients and disease areas.”

In response to the European Commission Trade Communication published on 18 February 2021. During Covid-19, Medicines for Europe was strongly engaged to ensure continued access to medicines for patients while protectionism, hoarding measures and panic policies undermined these efforts. The emergency has highlighted the need for closer international health collaboration and for governments to work together with industry to balance emergency health measures with free flow of medicine supply chains. Since the pharmaceutical sector is highly regulated, stronger international regulatory cooperation, especially related to generic and biosimilar medicines which represent the overwhelming volume of medicine supplies, would reduce unnecessary duplications for industry and regulatory agencies, and improve equitable access to medicines.

The EU should focus its trade agenda on pharmaceuticals on the following measures:

• Stronger cooperation on supply chain security. While emergency health measures are needed in a crisis, they can unintentionally undermine access to medicines by blocking trade in medicines or their components.  In a joint effort with the WHO and the WTO (to cover health emergency and trade matters), governments should align on specific mechanisms to limit the potential disruption caused by emergency health measures to the medicines manufacturing supply chain. This could be complemented at the bilateral level by extending Good Manufacturing Practice (GMP) mutual recognition agreements with other highly regulated markets starting with the UK.
• Stronger regulatory cooperation. The Commission should promote global generic and biosimilar development programmes to accelerate access to essential medicines and eliminate the unnecessary duplication of regulatory steps.
• Defend open trade. The EU should vigorously support the opening of medicines procurement markets and oppose with equal vigour the reneging of existing commitments by the US in the WTO Government Procurement Agreement;

• Stronger cooperation on Intellectual Property. Europe has one of the strongest IP system at global level. It is fundamental that any negotiation on IP with third countries is balanced and take into account the market, legal and regulatory environment of both regions. Therefore, in trade negotiations, the European Commission should evaluate the concrete impact of IP on generic and biosimilar medicines access for both parties. In addition, it should be assessed whether the imposition of European IP standards in third countries has a positive effect on export of European manufactured medicines.

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