A majority of EU member states are pushing for legislation to address shortages of critical drugs and to reduce dependency on imported chemicals from China and other countries.
In a paper seen by the Financial Times, Belgium and 18 other countries — including Germany and France — have gone further than Brussels’ recent proposals to overhaul the bloc’s pharmaceuticals laws, calling for a “last-resort” mechanism to swap medicines between member states and the establishment of a list of critical drugs whose supply chains must be monitored.
The Covid-19 pandemic and Russia’s invasion of Ukraine have thrown into sharp relief both the fragility and strategic importance of pharmaceutical supply chains.
“It’s a bit like Russian gas,” said an official from one of the countries pushing the proposals. “When it’s cheap and flowing, it’s great for your industry. Until it doesn’t, and then it’s really expensive.”
Since suffering severe shortages of Covid jabs at the beginning of the vaccination campaign in 2021, Europe has had to contend with problems in the supply of antibiotics, blood clot drugs and insulin, as well as fever and pain medications.
“Medicines shortages have partly been caused by the increasing monopolisation in the market,” said Frank Vandenbroucke, Belgian health and social affairs minister. “Imagine what a pandemic, natural disaster, war, or even a manufacturing glitch could mean for the world’s supply of medicines. Within the EU and with our partners globally we are now looking at ways to secure supply.”
According to the Pharmaceutical Group of the European Union, more than three-quarters of its member countries surveyed in 2022 reported a worsening of drug shortages.
The scarcity problem has been compounded by inflationary pressures that have raised costs and eaten into the margins of generic drugs makers, which typically sell at much lower prices than branded versions.
Another concern is that the production of active pharmaceutical ingredients, the key inputs of medicines, is concentrated in regions of China and India. The paper said this made supply chains potentially fragile in the event of geopolitical or macroeconomic disruption.
“The EU is becoming increasingly dependent on imports from a few manufacturers and regions for its medicines supply, adding a security dimension to the question,” the paper said.
“In 2019, globally more than 40 per cent of APIs were sourced from China. Furthermore, almost all API producers depend on China for intermediate inputs, even if they are located in another country.”
For half of these crucial ingredients, there were only five manufacturers in the world, the paper said.
The EU already aims to tackle some of these issues with a vast overhaul of pharmaceutical legislation for the bloc, announced last week. The initiative, which needs approval from member states and the European parliament, aims to create a single market for medicines to ensure equal access to drugs, with rewards for drugmakers that supply the bloc’s 27 countries.
The EU’s draft legislation also includes plans to take control of drug production in the event of a public health emergency. It includes plans for a list of critical drug ingredients, a requirement for stockholders to inform Brussels of supply levels and for manufacturers to alert Brussels if they are facing shortages.
However, the 18 member states want to go further. Another proposal for a “Critical Medicines Act” would use planned EU legislation on computer chips and critical raw materials as blueprints, the paper said.
The paper will be discussed at an informal meeting of health ministers this week in Stockholm. The European Commission declined to comment.
