COVID-19 has highlighted the risks of medicine shortages. What is the EU proposing to tackle this?
Planning the way forward based on the lessons learnt from this pandemic, the European Parliament’s Environment, Public Health and Food Safety Committee is proposing to restore pharmaceutical manufacturing in Europe, to create “an emergency European pharmacy” and better coordinated health strategies among member states.
What has led to this?
Learning from COVID-19
At the start of the coronavirus pandemic, European Council president Charles Michel had presented the four priorities to combat it: limiting the spread of COVID-19, ensuring the provision of medical equipment, tackling socio-economic consequences and promoting research. This was followed by further political debate on how the EU can boost the development of a coronavirus vaccine and treatment.
Alongside the need to research, find and produce a vaccine to combat the pandemic, the COVID-19 health crisis has also highlighted another growing issue: the shortage of medicines and medical equipment, which puts lives at risk and national health systems under pressure.
Alarm bells
On March 31, the European University Hospital Alliance warned how, due to the spread of COVID-19 and the rising demand for certain anaesthetics, antibiotics, muscle relaxants and other medicines used in a way that they were not originally approved for in coronavirus treatment, could mean stocks would run out. This would mean that front-line hospitals might no longer be able to provide adequate intensive care in a matter of weeks.
Response
On April 8, in a communication, the European Commission issued guidelines on the optimal and rational supply of medicines to avoid shortages during the pandemic. The aim of these guidelines, according to the Commission, was to protect public health and preserve the integrity of the single market, while ensuring Europe had the supply of affordable medicines it needs during the COVID-19 outbreak.
On July 15, the Commission presented immediate short-term measures to strengthen EU health preparedness for COVID-19 outbreaks, underlining that continued vigilance and fast response from the Commission and the member states is essential to ensure that the spread of the virus can be contained and new, generalised lockdowns can be avoided. The communication lays out a number of priority actions that include ensuring of the smooth supply of personal protective equipment, medicines, and medical devices.
What causes medicine shortages?
Causes are many and complex, and have been linked to manufacturing problems, industry quotas, legal parallel trade, but also to economic aspects, such as pricing – which is decided at national level – and unexpected peaks in demands. The coronavirus crisis has brought to the fore the geopolitical dimension of these shortages - the EU is increasingly dependent on non-EU countries, mainly India and China, when it comes to the production of active pharmaceutical ingredients, chemical raw materials, and medicines.
According to a note by the European Commission, between 2000 and 2018, medicine shortages in the EU increased 20-fold and rising for widely used essential products. Of those medicines in short supply, more than 50 per cent are medicines used to treat cancer, infections and disorders of the nervous systems.
Self-sufficiency
On July 14, the Environment, Public Health and Food Safety Committee called for the EU to have more self-sufficiency and better-coordinated strategies to tackle medicine shortages. The committee adopted a report, calling for European health ‘independence’ by securing supplies, restoring local drug manufacturing, creating an ‘emergency European pharmacy’ and ensuring better EU coordination of national health strategies.
Pharmaceutical Strategy for Europe
The COVID-19 crisis has shown that the EU needs to make sure medicines – including vaccines – are available at all times and under all circumstances.
In this spirit, on June 16, the European Commission launched a three-month online public consultation on the Pharmaceutical Strategy for Europe. The strategy - which would also act within the context of the newly proposed EU4Health Programme, and align with Horizon Europe for research and innovation - aims to make Europe’s supply of safe and affordable medicines future-proof, while supporting the European pharmaceutical industry to remain an innovator and world leader.
The strategy also intends to reduce the dependency that the EU has on imports from third-countries – currently, 40 per cent of medicines marketed in the EU originate in non-EU countries, while 60 to 80 per cent of active pharmaceutical ingredients are produced in China and India.
MEPs are encouraging the introduction of financial incentives to persuade producers to make active pharmaceutical ingredients and medicines in Europe.
Better coordination between EU countries
The report by the Environment, Public Health and Food Safety Committee also calls for better coordination between EU member states in sharing best practices in medicine stock management and also create coordinated health strategies, including further use of the joint EU procurement of medicines. The report also calls on the Commission to create a European contingency reserve of medicines of strategic importance, inspired by the RescEU mechanism. Access to this reserve stock should be ensured to all member states through a new mechanism of just distribution.
What’s next?
Expect the report on the European Parliament’s agenda at its September plenary session. The open public consultation on the Pharmaceutical Strategy for Europe is running until 15 September 2020 on EUSurvey.
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