The COVID-19 pandemic continues to have a serious impact. Although Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus, including those related to data availability, the supply of medicines and the availability of capacity to adapt and support medicine production.
The conclusion of advance purchase agreements for vaccines is nevertheless an example of effective cooperation between public and regulatory authorities, industry and civil society.
The anticipated widespread and equitable availability of safe and effective vaccines in record time raises hope for an exit from the crisis, providing inspiration for a renewed, innovative, patient-centred pharmaceutical sector.
“Although Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus”
A new EU approach must ensure we have a fair, competitive and green industry that delivers for patients, drawing on the potential of the digital transformation of health and care and driven through advances in fields such as AI and computational modelling.
We need well-functioning international supply chains and a well-performing single market for pharmaceuticals, through an approach that covers the entire lifecycle from production to disposal.
The Pharmaceutical Strategy for Europe, adopted at the end of 2020, aims to create a future-proof regulatory framework and to support industry in promoting research and technologies that actually reach patients to meet their therapeutic needs while addressing market failures.
It is based on four pillars: ensuring access to affordable medicines for patients and addressing unmet medical needs, supporting the competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high-quality, safe, effective and greener medicines, enhancing crisis preparedness and response mechanisms, diversified and secure supply chains, address medicines shortages and ensuring a strong EU voice by promoting high-quality efficacy and safety standards.
The Strategy is supposed to help establish a future-proof and crisis-resilient EU pharmaceutical system, as the COVID-19 pandemic has demonstrated the obsolescence of much of Europe’s health sector. For example, medicine shortages are a growing threat.
The EU and Member States must act decisively to prevent these shortages and mitigate their effects. In terms of supply chain issues, the COVID-19 situation has underlined certain vulnerabilities of the current European approach to sourcing medical products and active pharmaceutical ingredients from outside Europe.
It is important to have a better, more long-term dialogue between regulators and the industry on this issue, improving data sharing and earlier projections on where shortages may occur in the future. I strongly advocate for greater European coordination and information sharing to address this problem.
We support the promotion of diversification of supplies and supply chains to ensure availability and accessibility of medicines and medical equipment. Europe must immediately establish an action plan to address the shortage of essential and lifesaving medicines, support a strategic stock of medicines and medical equipment and, in times of crisis, avoid internal and external disruptions of the Single Market.
It is worth mentioning that the Parliament’s EPP Group strongly advocates for reinforced attention to health within the existing European Programme for Critical Infrastructure Protection (EPCIP) - currently focused on transport and energy – and identifying and designating European Critical Health Infrastructures. It also supports increasing the European Commission’s involvement in supporting critical health infrastructure protection in Member States.
The European Union does have great potential for regulatory and fiscal action within the existing constitutional framework. The proposed Regulation on Health Technology Assessment, which relates to new medicines and certain new medical devices serves as a basis for continuous cooperation at EU level in joint clinical evaluations in these areas.
“Europe must immediately establish an action plan to address the shortage of essential/lifesaving medicines”
Member States will be able to use common instruments, methodologies and procedures for assessing health technologies, with emphasis on joint clinical evaluations of the most innovative health technologies with the greatest potential impact on patients. A final Council decision is awaited for the adoption of the aforementioned Regulation.
In addition, a system of joint public procurement of strategic medicines and medical devices at European level could lead to easier availability and lower prices for less-developed and smaller Member States, whose individual bargaining position with pharmaceutical manufacturers is otherwise weak.
Better implementation of the Directive on applying patients’ rights in cross-border healthcare would facilitate access to the best medical procedures for patients.
I strongly support actions under the EU4Health programme supporting investments in critical health infrastructure, tools, structures, processes, and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks.
I also support the implementation of a pharmaceutical strategy translating the European Health Autonomy Action Plan into a permanent approach, aimed at securing the supply of medicines and lowering the EU’s dependence on third countries through simplified procedures without jeopardising safety and efficacy.
Given the challenges related to the sustainability of health systems, this new pharmaceutical strategy must be coordinated with the new industrial strategy launched by the European Commission. For the benefit of all our citizens, we must take a coordinated view in establishing a genuine European Union for Health.