The European Union’s just-released and first essential medicines list is the latest in a series of measures designed to limit the bloc’s reliance on countries outside its borders and avoid drug shortages. As Elisabeth Stampa of generic and biosimilar lobby group Medicines for Europe recently explained to PharmaBoardroom, this is just one of a series of efforts being rolled out to step up Europe’s ‘strategic autonomy’ in essential medicines and ingredients.
Bringing Production Back to Europe
If the COVID-19 pandemic set off concern about Europe’s reliance on countries such as China and India for its critical medicines, last year’s extensive shortages and current geopolitical tensions have further heightened the push towards nearshoring. “This is a topic that we have long advocated for, but the COVID-19 pandemic and subsequent medicine shortages reinforced its importance and increased public awareness,” says Elisabeth Stampa, president of Medicines for Europe, an advocacy group for the generics and biosimilars industries.
“Production of many high-volume products has shifted to lower cost regions outside of Europe’s borders in recent years, given the pressure on costs here, which led to shortages during the surge in demand that COVID brought about,” she laments.
[Increasing medicine production in Europe based on sudden demand] “is not like hiring more staff at a supermarket to deal with the Christmas rush … All these products are produced under strict GMP regulations, meaning that a skilled and well-trained workforce is necessary”
Elisabeth Stampa, Medicines for Europe
The European Union has recognised the need to rethink the law governing pharmaceuticals in Europe and has taken steps towards avoiding drug shortages in the EU. To this effect, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first version of the European Union’s list of critical medicines, which includes a wide range of essential generic medicines, including basic antibiotics, painkillers such as paracetamol and morphine, and insulin to treat diabetes.
The EMA has also created a voluntary solidarity mechanism this year. Developed by the EMA Medicines Shortages Steering Group (MSSG), along with a toolkit for avoiding drug shortages, which advances measures for EU member states to support each other with respect to critical medicine shortages.
While Stampa is supportive of the idea, she is realistic about the challenges involved. “There are a few main problems with the voluntary solidarity mechanism,” she asserts. “The first is establishing which products should be included and deciding where they should be kept. The second is how to plan for a huge increase in demand … As there is no unified EU patient database, demand planning would be extremely challenging. Moreover, the entire production process takes at least six months or more … meaning that we would need to know in May how many cases there will be in November.”
Immediately increasing production in Europe based on sudden demand is not always feasible, Stampa argues. “All these products are produced under strict GMP regulations, meaning that a skilled and well-trained workforce is necessary. It is not like hiring more staff at a supermarket to deal with the Christmas rush.”
Roadblocks to European Manufacturing
Voices have gone up among EU member states for the introduction of a Critical Medicines Act, like the Critical Minerals Act that would create more resilient supply chains and establish more drug autonomy. However, ensuring finished pharmaceuticals and active pharmaceutical ingredient (API) production in Europe involves several issues, one of which is obviously cost. With higher labour and operational costs, it is difficult for Europe to compete with countries such as China and India. “At the end of the day, there is labour involved, and other geographies are able to be much more competitive than Europe on costs,” Stampa bemoans.
Europe’s stringent environmental policies could be considered another barrier to setting up manufacturing operations in the EU, yet Stampa feels that European producers are already making an environmental shift. “All producers in Europe, whether of APIs or finished products, are heavily investing in green technologies to comply with the EU’s restrictive legal requirements,” she claims.
Another consideration is that while Europe may want to boost production within its borders, there are pushbacks to factories sprouting up in Europeans’ own backyards. Stampa remains pragmatic: “We must adopt a balanced approach. If we want medicine manufacturing in Europe, then we should accept that, in some industrial areas, medicines will be produced,” she says, arguing that Europe’s environmental control has turned out to be an advantage. “The environmental restrictions are extremely stringent and finished product manufacturing is considered a clean industry.”
Reshoring Already Underway
According to Stampa, the tendency to develop more sophisticated and efficient production processes among Europe’s medicines manufacturers, especially in terms of digitalisation, electronic batch records, electronic lab notes, and biocatalytic processes, has brought some production back to Europe. “These trends are already leading to reshoring and, while reshoring all production to Europe is unrealistic, there are more products once more being manufactured in Europe. In some cases, this is because companies have found more efficient ways of manufacturing.”
