Too much at stake in the EU pharma strategy to get it wrong: how the EU can deliver equitable access to medicines

In some ways, the European Union has historically shied away from leading on access to medicines. Stuck between treaty-enshrined competences on health – or lack thereof – and member states’ reluctance to harmonise health policy, the EU has flourished in a space of best practice sharing and awareness building. Both activities are fundamental, but sometimes lack the conviction and follow-through of concrete action and policy.

But in early 2020, the whole world changed. COVID-19 was spreading in Europe and countries were frantic to react. After a rough start, it became evident that greater pan-European coordination and solidarity was necessary on the procurement of hospital equipment, personal protective equipment (PPE) and medicine supply.

The off-patent medicines industry supplies the vast majority of medicines used in intensive care units – between 70% and 90% – when a patient needs to be mechanically ventilated. Medicines for Europe worked with the European Commission to ensure that medicines kept moving when Europe’s borders were closing down and manufacturing was ramped up where needed.

Several factors have proven to be crucial, including dialogue and predictability of market demand, as well as strong supply chain resilience – which has been severely tested throughout the current crisis. Working together, we succeeded in avoiding major shortages and we have learned that pan-European solidarity in health is key to ensure equitable access. Alone, member states’ supply chains may operate faster, but Europe is stronger together.

Although COVID-19 has been at the front of everyone’s mind over the past months, we cannot forget the countless other diseases that challenge health systems and people every day. Major chronic diseases like cardiovascular disease, auto-immune conditions, respiratory conditions and cancers did not cease to exist during the pandemic. Access to care has been severely impacted either by fear of seeing a doctor or by the disruptions created by the pandemic on medical units. The suspension of screening programmes and routine check-ups may put health systems in a very uncomfortable position over the years to come and previous efforts to ramp up prevention programmes may be jeopardised. We absolutely must find a way to resume chronic disease care as we live alongside COVID-19 to prevent an avalanche of otherwise manageable diseases. No one should be left behind; the impact of the virus on non-COVID-19 patients should be monitored and barriers of access to care addressed.

Having learned a great deal from a global pandemic, it is so important to address the shortcomings that have been exposed, especially in the implementation of the EU Pharmaceutical Strategy.

Launched in late 2020, the strategy is a blueprint for building better access to medicines in Europe. It focuses on four key pillars that, complemented with smart policy proposals, will lead to a stronger European health ecosystem. The EU proposes taking action on access and availability, affordability, innovation for unmet medical needs and industrial competitiveness.

And there is a lot at stake within these four pillars. The off-patent medicines sector represents close to 70% of medicines dispensed in Europe, accounting for 2-3% of the European pharmaceutical healthcare budget, and over 400 manufacturing sites across Europe. Treating patients with major chronic diseases with gold standard generic, biosimilar and value added medicines, Medicines for Europe sits at the centre of an ecosystem which stimulates greater innovation while ensuring more equitable access to affordable medicines. To work properly, this ecosystem deserves some adaptations that the EU Pharmaceutical Strategy must deliver, notably in four main areas.

First, prioritising access and encouraging healthy competition by removing access barriers and stimulate uptake to generic and biosimilar medicines.

Second, supporting Europe’s manufacturing resilience by stimulating a diversified and robust supply chain via smart and sustainable market reforms. Some cost-containment measures or procurement models are fuelling the industry’s concentration and its migration, together with technology and know-how, outside of Europe. This should be addressed in a sustainable way as it creates vulnerabilities in the supply chain.

Third, developing an EU plan on security of supply to tackle medicines shortages by enhancing Europe’s solidarity, which has become a prerequisite as proven by COVID-19. A pan-European plan and coordination is needed. Any disproportionate regulatory requirements, such as obligation to supply, penalties or ill-conceived stockpiling, will fragment the single market and threaten products’ economic sustainability, which ultimately may lead to further shortages.

Finally, boosting the transition towards digital healthcare. Too many patients’ access to care has been affected negatively by the pandemic. New digital pathways can offer them a safe way to be treated from home. We need to embrace this. At the same time, we must also increase the use of digital tools, notably in the regulatory framework. Digital technologies can bring cost efficiencies for both industry and regulators, alongside increased sustainability, while enabling harmonised and prompt answers during emergencies.

Protecting access to affordable medicines, while supporting a vibrant and strategic medicines manufacturing base in Europe, is essential for sustainable and equitable access to medicines. The COVID-19 outbreak has brought many pre-existing issues to the fore, and the vision outlined above can help shape future EU action on health to drive better health for European patients. There is too much at stake to get this wrong! By working together, we can implement acceptable policy reforms for all, providing patients with the access to medicines they need at all times, while keeping a vibrant and competitive off-patent sector in Europe.