Chief Pharmaceutical Officer in France: A unique status that Europe might change?

Three million euros’ worth of medications were held up following a slight temperature fluctuation, and the CEO demanded that the Chief Pharmaceutical Officer release them immediately. The response came back immediately and unequivocally: a categorical refusal.

For executives of foreign pharmaceutical companies or young healthcare startups establishing a business in France, this situation raises questions. How can an executive oppose his superiors so firmly, cause his company to lose millions of euros, and yet remain completely protected in the performance of his duties?

The answer lies in the unique nature of the position of Chief Pharmaceutical Officer in France. Far from being merely an administrative box to check on a list of regulatory requirements, this position is based on a social mandate, a legal right of veto, and personal criminal liability.

This is an exceptional model in Europe that the European pharmaceutical package has maintained to date.

 

 

The Chief Pharmaceutical Officer in France: much more than just a compliance role

When a pharmaceutical company prepares to open an exploitant site in France, the law requires the appointment of a Chief Pharmaceutical Officer.

Many executives equate this role with that of a traditional quality director or a regulatory affairs manager. This is a major legal misunderstanding.

In business law, the Chief Pharmaceutical Officer in France is a full-fledged corporate executive. He or she must hold a corporate office within the exploitant site. This position grants him or her legal prerogatives:

• A veto power enforceable against senior management: the Chief Pharmaceutical Officer has the legal authority to prohibit the release or distribution of a product if it determines that quality, safety, or compliance are not guaranteed.
• Personal criminal and civil liability: in the event of a healthcare-related failure, it is the Chief Pharmaceutical Officer who faces direct criminal prosecution in court, regardless of the legal entity.
• Personal commitment to one’s professional credentials: each signature directly commits the Chief Pharmaceutical Officer to their status as a healthcare professional and their right to practice their profession.

Carole Souchaire, co-founder of Alhena Consult and an expert in pharmaceutical accountability, illustrates the reality of this daily tug-of-war: a CEO who asks his Chief Pharmaceutical Officer to release a non-compliant product will not get that approval, even if the refusal were to cost the company three million euros, because patient safety takes precedence over any economic consideration.

This professional independence is essential to the functioning of all pharmaceutical operations. This is why some professionals refuse to make any concessions when they provide support at external facilities as deputy Chief Pharmaceutical Officer. Carole Souchaire points out that by accepting an assignment as deputy Chief Pharmaceutical Officer., she assumes responsibility and puts her professional license on the line, which leads her to decline any request from senior management to release products that do not meet specifications.

 

Commercial Release: a process unique to the French Market

Another feature specific to France is that the review process does not end with the manufacturing site’s release by the Qualified Person (QP). Even if a product has already been released in another EU country (such as Greece), the French Chief Pharmaceutical Officer must perform a separate commercial release.

In particular, he/she verifies the shipping documents, any temperature deviations, and the compliance of the packaging. If the cold chain has been interrupted beyond the stability limits, the Chief Pharmaceutical Officer blocks the product’s release onto the French market, ensuring the health and safety of French patients.

 

 

Qualified Person in Europe: same title, radically different status

In European legislation, the term “Chief Pharmaceutical Officer” could be interpreted as the “Qualified Person” (QP). However, this is a fundamental error. In reality, the French legal framework and the European framework are based on profoundly divergent principles.

 

Degree requirements and the concept of a pharmaceutical monopoly at the European Level

In France, the Chief Pharmaceutical Officer must hold a Doctorate. in Pharmacy and be registered with the Order of Pharmacists (Section B). In the rest of Europe, the qualified individual is not necessarily a pharmacist: a quality engineer, a biologist, or any person with the required skills may hold the position.

 

Criminal liability and status within the company

In France, the marketing of a drug by an exploitant site must be overseen by a Chief Pharmaceutical Officer who holds a corporate officer mandate. This mandate serves as the foundation of the Chief Pharmaceutical Officer’s personal criminal liability and safeguards their independence. In contrast, the European QP is most often a regular employee of the company. The QP does not bear comparable personal criminal liability and does not benefit from an equivalent statutory protection vis-à-vis company management.

 

 

The European pharmaceutical package: what changes lie ahead?

This French legal exception raises questions in its current form. The “Pharmaceutical Package” constitutes a major overhaul of European pharmaceutical legislation, with Directive 2001/83/EC being one of the key texts under revision.

 

Brussels questions France’s monopoly

At the heart of the negotiations in Brussels is the desire to simplify procedures and remove barriers to the harmonization of the single market. European regulators have asked a straightforward question: Why is France the only member state that requires a member of management to be a licensed pharmacist?

Some industry stakeholders believe that future developments in Europe could lead to a reassessment of the status of the Chief Pharmaceutical Officer in France.

 

Mobilization of the profession

Faced with this prospect, the National Council of the Order of Pharmacists and other local professional organizations are organizing resistance. The main argument put forward by defenders of the French system is simple: the personal criminal liability of the pharmacist is the only true safeguard ensuring patient safety in the face of shareholders’ financial demands. It is particularly through the AFAR (French Association for Regulatory Affairs) that pharmacists share their experiences from the field (feedback from audits or inspections), notably through working groups and at evening events covering current regulatory topics.

 

What is the timeline for laboratories?

The new directive is expected to be transposed into national law within the next two years. As of now, nothing has changed: the requirement to designate a Chief Pharmaceutical Officer who holds a corporate office remains the absolute rule in France.

However, for any pharmaceutical company seeking to establish itself or sustain its operations in France, this is a major regulatory issue that must be closely monitored.

 

 

While the titles of the French Chief Pharmaceutical Officer and the European Qualified Person may seem similar, their responsibilities and decision-making autonomy differ completely. The French Chief Pharmaceutical Officer risks his professional license and faces criminal liability to protect public health, including against financial considerations made by his own management. As Europe considers harmonizing this role as part of the pharmaceutical package, understanding its specific characteristics helps us assess what is at stake.

Are you preparing to launch a pharmaceutical product in France, or do you need to restructure your quality management department? Discover our consulting and support services for Chief Pharmaceutical Officer and deputy Chief Pharmaceutical Officer to ensure robust governance and help you navigate the French regulatory framework with confidence.

 

 

Sources:

Public Health Code – Article L. 5124-2 (Status, Management, and Term of Office of the PR)
Public Health Code – Article R. 5124-36 (Duties and Powers of the PR)
Directive 2001/83/EC (EUR-Lex / Légifrance – European Framework Text on Medicines)
The European Pharmaceutical Package (EU Reform and New Rules)
National Order of Pharmacists – Section B (Industry)