Interview of Jean-François Hilaire by PHARMAnetwork magazine – N°58 ; P51

Traditionally, in Europe, authorities have regulated pharmaceuticals from a quality standpoint with good manufacturing practices (GMP) and from an economic standpoint with various price-setting schemes. Despite GMP regulations being unified, the price settings vary, which results in confusion about distribution channels and in economic constraints for certain products.

Furthermore, competition with generics has generated a need to reduce production costs, which has been achieved by consolidating worldwide demand for a given product or intermediate in a limited number of supply centres, often located in low-labour-cost countries, principally China. This has resulted in an increasing number of drug shortages over the last years, reaching a peak during and after the Covid-19 pandemic, although the supply of Covid-19 vaccines in Europe (manufactured in Europe, incidentally) has been remarkably efficient.

Economic constraints faced by drug manufacturers

New hurdles lie ahead for manufacturers. For instance, implementing Annex 1 to the European GMP regulation and increasing requirements more generally from various regulations may require them to make massive investments in production facilities that they may not be able to afford. This will result in the obsolescence of a large number of sites. Meanwhile, environmental sustainability will limit our access to water and the possibility of erecting new buildings, as well as increasing energy costs. These measures are legitimate, as they are part of our responsibilities as entrepreneurs, but the economic framework in which pharmaceuticals are produced will not allow all players to cope with so many constraints.

Relocating pharmaceutical manufacturing to Europe

To allow pharmaceutical manufacturers to invest reasonably in production capacity ahead of their immediate needs, a genuine policy is needed for relocating pharmaceutical manufacturing to Europe, with support for access to land and utilities and with predictable regulatory and economical terms, enabling companies to build facilities and connect to utilities within a predictable regulatory and economic framework.

In order for this to be successful, it should be combined with reasonable drug pricing schemes, governmental support with capital to ease investment, and access to qualified staff, otherwise it will take decades to be implemented, if indeed it happens one day at all. Such initiatives should not be limited to critical medicines. It is also important to make sure that innovative treatments that are developed in Europe with tax relief support from various member states remain in Europe for their commercial production. As this assumes investments in facilities by various industry stakeholders, this would also require governmental incentive measures.

The CDMO’s mission: delivering the ordered product quantities at a competitive price

In the short term, in addition to the structural measures suggested above and reporting of drug shortages, ensuring transparency around available inventories for a given product throughout Europe for Marketing Authorisation holders would allow them to keep much tighter control over their supply chain and forthcoming demand. This information can then be transferred digitally to their suppliers, namely us as CDMOs.

As a CDMO, our mission is to deliver the quantities of products ordered by our customers at a competitive price. This means that we need access to all the required components (active ingredients, excipients, packing materials) on the one hand, and adequate utilisation of our production assets with ideally stable and predictable demand on the other. Production sites located in Europe could then react swiftly to any change in demand within such a controlled frame.

Additionally, authorities might think about a specific regulatory process to allow swift change when there is an urgent need. This could be to substitute a component that becomes unavailable or following an accident, such as the storm that shut down the Pfizer US site in North Carolina in July 2023. To conclude, Europe is a prime location to develop and manufacture pharmaceuticals for domestic needs, as well as for export. Creating a favourable environment for entrepreneurs in this field is not only addressing a healthcare necessity, but also preparing the future for the next generations, a long-term endeavour.