The current sale of Opella, the Sanofi subsidiary responsible for marketing Doliprane, to an American investment fund, may have sparked lively debates. In question, the risks that this transfer poses to our national pharmaceutical sovereignty.
[Article issu de The Conversation, écrit par Clotilde Jourdain-Fortier, Professeur en droit international économique – CREDIMI, Université de Bourgogne et Mathieu Guerriaud, Professeur des universités en Droit pharmaceutique et de la santé – CREDIMI, Université de Bourgogne]
This session must be placed in the context of globalization which has led to relocations. These make France dependent on distant production chains, so much so that sovereignty is today threatened in several strategic sectors, including pharmacy. Faced with these threats, the relocation on national or European territory of production factories for a certain number of products considered vital for the population appears necessary.
Assemble or produce?
France has no shortage of facilities to manufacture drugs like Doliprane, but it still lacks factories to produce active substances. Paracetamol is now imported to more than 85% of regions outside the European Union (EU), mainly from China and India.
A medicine is in fact composed of one or more active substances, excipients and packaging items. In the case of Doliprane, Opella produces the tablet, that is, assembles the paracetamol (the active substance) and the excipients (such as povidone), which ensure the strength and stability of the tablet.
3 billion in financing
The risks of disruptions in our supply chains led Emmanuel Macron to decide in June 2020 to relocate production to France thanks to the granting of massive public aid to pharmaceutical companies.
The initiative is compatible with European law which seeks to “promote the realization of an important project of common European interest (IPCEI)” involving several Member States, i.e. an active European industrial policy when the market proves to be failing. An “IPIEC Health” was thus launched by sixteen member states, including France, in March 2022, to “support innovation and improve the quality and access to care for European patients”. It appears today as the means of concretizing the French and European strategy of relocalization of the production of medicines, and of providing significant financing compatible with the European state aid regime (France has mobilized, within the framework of France 2030, a health budget of 3 billion euros).
Significant public aid was granted in June 2021 to the company Seqens, for the construction of a new production plant on its main industrial site in France, with the aim of producing up to 10,000 tonnes/year of paracetamol and distribute it in France by 2025. Seqens was owned by a French investment fund (Eurazeo) since 2016, but from December 2021, the company was bought by an American investment fund, raising many questions given the risk of seeing the production of paracetamol once again relocated to a third country and the French market unsupplied.
Why did the French government not oppose this takeover then, and does it not oppose that of Opella today? As of 2019, the EU adopted a mechanism for filtering and controlling foreign direct investments, which aims to “contain” takeovers of our “national champions” by investors from third countries. States may take measures aimed at authorizing, subjecting to conditions, prohibiting or even canceling the acquisition of the property of a company resident in their territory as long as it harms or risks harming assets deemed “strategic”.
A balance to find
In France, the Minister of the Economy has a “right of veto” which allows him not to authorize a takeover in a sensitive sector. And even when it authorizes it, it can condition its authorization and has the means since the 2019 Pacte law to enforce the initial conditions. It can withdraw its authorization, order the foreign investor to respect the conditions set if necessary by means of a penalty and apply financial penalties.
However, the balance to be found is delicate between seeking to attract international capital necessary for the reindustrialization of the territory, while refusing to allow them to subsequently leave as part of a relocation. Therefore, the solution does not consist, systematically, in opposition to such takeovers. There are multiple avenues to explore to secure them within the framework of a partnership with the private sector (without which the reindustrialization policy cannot be carried out).
The minority’s room for maneuver
Integrating the French State into the capital of the new company via Bpifrance in particular is one possible route. By becoming a shareholder, even a minority shareholder, the State takes part in the governance of the company and intends to exercise a certain control over the commitments that the foreign investor may have been forced to make in terms of industrial relocation. Making the granting of public aid conditional on commitments not to relocate production is another, just as making the authorization of the Minister of the Economy for the purchase of the company conditional on commitments from the foreign investor in terms of preserving the sustainability of activities, industrial capacities and research and development on French territory.
This seems to have been the case with the takeover of Seqens and that of Opella by an American investment fund. The absence of opposition to these sensitive takeovers demonstrates commitments made to ensure the continuity of the manufacturing of paracetamol in France by Seqens which, linked by supply contracts with Opella or UPSA, will continue to supply them to enable them to assemble Doliprane in France, for the needs of the French market.
Why is Sanofi selling Doliprane?
Sanofi, for its part, ensures the future of the group and of French pharmacy: although very popular, Doliprane is in fact not very profitable. Sanofi intends through this sale to free up substantial funds to invest in therapeutic areas with higher added value, such as oncology or rare diseases. In this logic of diversification, the company acquired Provention Bio in 2023 for 2.9 billion USD and in May 2024, Inhibrx for 1.7 billion USD.
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