Healthcare sovereignty and pharmaceutical manufacturing

The Covid-19 pandemic of 2020 revealed the extent to which European nations depend on imports of medicines and the active pharmaceutical ingredients essential to their manufacture. The issue of healthcare sovereignty was thus raised once again at an EU level and a number of member states declared their desire to secure their supplies of medicines, in particular by relocating industrial production and boosting their domestic capabilities. David Papillon, who is overseeing for Artelia the design of the Seqens paracetamol plant in Roussillon (SE France), tells us what he has learned about this new movement taking shape in France.

How closely do European states depend on medicine imports from other countries?

The authorities estimate that 40% of the medicines sold in European states currently come from third countries. The trend is even more marked in the case of active pharmaceutical ingredients (APIs), of which 60% to 80% are currently manufactured in China and India .
Paracetamol, which I am working on at the moment, is a perfect – you might even say extreme – illustration of this. It is an essential substance that is widely used as a painkiller. But it is also an old, commonplace product, so its sale price is quite low. As a result, its manufacture has gradually shifted from Europe to countries where production costs are low. By 2019, Europe was almost completely dependent on third countries for its paracetamol supplies. About 40% of them came from China, 30% from India and 30% from the USA. During the peak of the Covid-19 pandemic in March and April 2020, these countries delivered just half of the quantities needed in Europe , casting a harsh light on our dependence.

What policies have been launched to reduce this dependence?

A number of strategies and proposals to boost our healthcare sovereignty have been announced, both by the European Union and the French government. The EU’s stated aim is to guarantee access to medicines at affordable prices, while encouraging the development of new products. The French government is also banking on research and innovation in new treatments, while also boosting the country’s industrial capabilities, which have declined significantly in recent years. The “France Relance” recovery plan and the Health Innovation 2030 plan tie in with these goals. These were also reaffirmed in summer 2023, when public funds were earmarked to support the relocation or development of pharmaceutical production in France.

How is Artelia involved in this industrial redeployment?

We have stepped up our efforts in this sector since 2020. Pharmaceutical industry firms are actively looking for engineering companies capable of meeting their needs, because the health issues involved in manufacturing mean they have specific requirements when it comes to qualifying their facilities. In a project to build a new pharmaceutical plant, everything from the production equipment to the IT systems to the building itself has to be qualified. Each component has to be checked and validated to ensure that everything delivered and installed complies to the letter with the manufacturing process specifications. This qualification process begins right from the design phase, with equipment checks at the suppliers’ premises, and continues on-site at each stage of plant construction right up to the final production test.
Artelia has some in-house specialists in qualification as well as solid industrial experience in all the key aspects of this type of facility (HVAC, clean rooms, water quality, etc.). More broadly speaking we have a long track record in refurbishing industrial facilities, and are a leading engineering company in the building construction sector, including its industrial segment.

What types of development project do you work on in France?

Since industrial facilities are constantly evolving, we are often commissioned to upgrade and extend plants, on behalf of clients in the sector such as Novasep, Ipsen, Aspen, Croda Pharma, and GSK. We also have teams who specialise in research and development facilities, and who regularly contribute to laboratory projects in the healthcare sector.
We are currently involved in two projects that exemplify the new wave of investment in the pharmaceutical industry, especially in the manufacture of active ingredients in France. At the Baclair site in Normandy, on behalf of Oril Industrie, we are involved in the design studies and construction supervision for a new workshop dedicated to the production of 90% Flavonoids , the active ingredient of Daflon®. And in Roussillon (Rhône-Alpes-Auvergne region), as I was saying, we are helping Seqens build a new paracetamol production plant, a major project which is fully in keeping with the country’s efforts to relocate production of essential medicines.

How does the Seqens project exemplify this movement to relocate production and boost healthcare sovereignty?

First of all, through its scale and the stakes involved. This plant will have a production capacity of 15,000 t per year, which is sufficient to cover about half of Europe’s paracetamol needs! Additionally, it is a good illustration of the conditions required to relocate this type of plant to France, from the technical, environmental and financial standpoints.
This plant is being built at an existing chemicals facility and can hence benefit from the utilities, laboratories, logistics and other services available on-site (water, steam, power, etc.). On the engineering front it’s a complex operation, because it has to be built in a constrained setting, partly reusing existing buildings. The production unit itself has to be raised to an elevation of 40 m, as it is a gravity-flow process. There are also nearly 250 main equipment items to manage – and qualify, about 13 km of pipework, and 1,500 sensors to control the facility.

On the environmental front, Seqens is going to implement a truly innovative manufacturing process. The company claims that CO2 emissions will be reduced by 75%, energy consumption by almost 65%, and solid effluent by 50% in comparison with a conventional facility. Liquid effluent will be fully recovered, treated and reinjected into the process. The set-up is instructive from a financial standpoint too, as it combines support from the State (via the “France Relance” recovery plan) with the participation of UPSA laboratories and Sanofi.
The name of the project, “Phoenix 15”, is highly symbolic, as Rhodia used to produce paracetamol on the Roussillon site, but shut its plant down in 2008. Like the mythical creature, the plant has risen from the ashes with a new lease of life.

How does Artelia intend to contribute to future projects in this sector?

We are continuing to build our capabilities to meet the needs of the pharmaceutical industry. In France, we are strengthening our teams at the country’s key pharma industry hubs (mainly Normandy, Rhône-Alpes, and the Paris region). In Europe, the Group has recently acquired the Danish company LBP Engineering, which is renowned for its expertise in the pharma and biotech industries.