Earlier this year, when the European Commission published its roadmap for the planned pharmaceutical strategy, it naturally did not have the Coronavirus crisis in mind. Instead it aimed to review the orphan medicinal products (OMP) regulation, legislation on fees for the European Medicines Agency (EMA), as well as the basic pharmaceutical legislation, which has become outdated since it entered into force in 2001.
The EU OMP Regulation, which has helped improve the lives of many rare disease patients across Europe, is a great example of how effective EU regulatory approaches can stimulate the availability and broaden access to treatment through a clear system of incentives aligned with unmet needs. It represents a unique opportunity to make Europe a hub for innovative medicines and ensure European sovereignty in this field.
The EU’s Pharmaceutical Strategy should ideally support Europe’s medical research and pharmaceutical ecosystem, enhance our continent’s healthcare systems and resilience to global health threats, as well as be a key driver for the EU’s economic recovery. A laudable central issue of the roadmap is the target of examining the affordability of medicines for patients and national health systems, especially in smaller Member States.
With great foresight, the text also addresses the EU’s growing dependence on imports of medicines and active pharmaceutical ingredients. In exceptional times like these, such dependence threatens the ability of the EU to act swiftly when protecting the health of its citizens.
Despite our wealth and human capital, we are operating with one hand tied behind our back, vulnerable to the whims and abilities of others who could become rivals in the race to fight this pandemic and protect our economy from entering further lockdowns. The fact that we have been faced with medicine shortages is intolerable.
Our joint actions and efforts need to be coordinated, to ensure that supplies are available, and continuity of treatment is guaranteed for all patients. One way to guarantee the availability and affordability of medical supplies and pharmaceutical ingredients is through joint public procurement. Such procurement would give Member States a better negotiating position, lower administrative burdens and minimise the risk of medicine shortages.
It is important to allow SMEs to take part in joint procurement procedures, as the price should not be the only criterion for awarding contracts. I support this approach for all medicinal products, not just those related to the Coronavirus pandemic, both afterwards and at a broader European level.
Together with other concerned colleagues from the European Parliament, we have asked the European Commission if it is planning to set up a high-level pharmaceutical forum, that brings together policymakers, regulators, payers, patients, industry representatives and other relevant stakeholders. This should be with a view to developing a shared and coordinated approach that addresses pharmaceutical sustainability issues such as shortages, and guarantees access for EU patients in a sustainable and competitive single market for the pharmaceutical sector.
“One way to guarantee the availability and affordability of medical supplies and pharmaceutical ingredients is through joint public procurement. Such procurement would give Member States a better negotiating position, lower administrative burdens and minimise the risk of medicine shortages”
We were pleased to see in the Commission’s response that there is a willingness to consider the establishment of such a high-level forum and that they agree that the COVID-19 pandemic has exacerbated the EU’s dependence on third countries for medicines and active pharmaceutical ingredients. It demonstrates the need for a future-proof strategy that incorporates the lessons learnt from managing the impact of the Coronavirus crisis on public health systems in the EU.
Setting up a European multistakeholder High Level Forum, with institutions, healthcare authorities, industry and patients, would provide for a platform for dialogue so that we can assess our healthcare challenges and, together, identify constructive solutions to ensure access for all. The issue of medicine shortages has long been discussed in the Council.
However, the demand for certain medicines has increased by more than 2000 percent during the crisis. In a discussion paper, the Croatian Presidency suggests several courses of action, including, “a certain level of regulatory flexibility may enable the reduction of the complexity and the cost of EU regulation.”
The document also refers to regulatory measures in the pharmaceutical field through, for example, earlier notification of shortages, transparency of quotas and wholesale transactions, or even stockpiling requirements for pharmacies. Parliament has an important role to play in defining policy solutions. I will support a strategy that guarantees patients in Europe have access to the safe and affordable treatments and vaccines they need and maintains a world-leading and innovative pharmaceutical industry in the EU.