A majority of EU member states are pushing for laws to handle shortages of important medication and to scale back dependency on imported chemical compounds from China and different international locations.
In a paper seen by the Monetary Instances, Belgium and 18 different international locations — together with Germany and France — have gone additional than Brussels’ current proposals to overtake the bloc’s prescription drugs legal guidelines, calling for a “last-resort” mechanism to swap medicines between member states and the institution of an inventory of important medication whose provide chains have to be monitored.
The Covid-19 pandemic and Russia’s full-scale invasion of Ukraine have thrown into sharp reduction each the fragility and strategic significance of pharmaceutical provide chains.
“It’s a bit like Russian fuel,” mentioned an official from one of many international locations pushing the proposals. “When it’s low-cost and flowing, it’s nice in your trade. Till it doesn’t, after which it’s actually costly.”
Since struggling extreme shortages of Covid jabs in the beginning of the vaccination marketing campaign in 2021, Europe has needed to deal with issues within the provide of antibiotics, blood clot medication and insulin, in addition to fever and ache drugs.
“Medicines shortages have partly been brought on by the rising monopolisation out there,” mentioned Frank Vandenbroucke, Belgian well being and social affairs minister. “Think about what a pandemic, pure catastrophe, battle or perhaps a manufacturing glitch may imply for the world’s provide of medicines. Throughout the EU and with our companions globally we at the moment are taking a look at methods to safe provide.”
In line with the Pharmaceutical Group of the European Union, greater than three-quarters of its member international locations surveyed in 2022 reported a worsening of drug shortages.
The shortage downside has been compounded by inflationary pressures which have raised prices and eaten into the margins of generic medication makers, which usually promote at a lot decrease costs than branded variations.
One other concern is that the manufacturing of energetic pharmaceutical substances, the important inputs of medicines, is concentrated in areas of China and India. The paper mentioned this made provide chains probably fragile within the occasion of geopolitical or macroeconomic disruption.
“The EU is changing into more and more depending on imports from a number of producers and areas for its medicines provide, including a safety dimension to the query,” the paper mentioned.
“In 2019, globally greater than 40 per cent of APIs had been sourced from China. Moreover, nearly all API producers depend upon China for intermediate inputs, even when they’re positioned out of the country.”
For half of those essential substances, there have been solely 5 producers on the planet, the paper mentioned.
The EU already goals to sort out a few of these points with an enormous overhaul of pharmaceutical laws for the bloc, introduced final week. The initiative, which wants approval from member states and the European parliament, goals to create a single marketplace for medicines to make sure equal entry to medication, with rewards for drugmakers that provide the bloc’s 27 international locations.
The EU’s draft laws additionally contains plans to take management of drug manufacturing within the occasion of a public well being emergency. It contains plans for an inventory of important drug substances, a requirement for stockholders to tell Brussels of provide ranges and for producers to alert Brussels if they’re dealing with shortages.
Nonetheless, the 19 member states need to go additional. One other proposal for a “Important Medicines Act” would use deliberate EU laws on pc chips and significant uncooked supplies as blueprints, the paper mentioned.
The paper might be mentioned at an off-the-cuff assembly of well being ministers this week in Stockholm. The European Fee declined to remark.