David Macdonald’s perspective on the French pharmaceutical industry


Since joining Rephine in August 2014, I have been actively engaged in increasing the company’s presence in Europe, most notably in France and the BENELUX countries. Having recently celebrated my second work anniversary with Rephine, I decided to write an article analysing the French pharmaceutical industry from my perspective.

As an openly unapologetic Francophile, I made visiting France on business a priority in my attempt to increase Rephine’s market share there and to improve relationships with existing French clients and auditees. I have visited the country ten times on business alongside Rephine’s CEO, Dr. Rino Coladangelo, travelling to regions including Ile-De-France, Normandie and Auvergne-Rhône-Alpes. Following the meetings I have had in France, it has become increasingly obvious to me that not only are third party audits still met with scepticism, but product audits are still preferred over site audits.

This scepticism towards third party audits has been a particular eye opener, not least because other companies outside of France appear to be much more comfortable with the concept. This was made all the more surprising by the fact that French pharmaceutical organisations adhere to the same GMP regulations and appear to make similar products to their European counterparts.

Following extensive conversations with French pharmaceutical companies, I have begun to see a shift in attitude among my French clients, the majority of whom now appear to be more open to the third party concept and the acceptability of the French regulatory authority (ANSM) towards it. Leading companies in France accept the concept and have wholeheartedly adopted Rephine’s third party audit program (click on the following link for more details: https://www.rephine.com/gmp-services/gmp-audits/. As a consequence, Rephine currently has six valid audit reports of manufacturing sites located in France, with at least another five French audits planned to take place within the next twelve months.

In addition to leading pharmaceutical companies, Rephine has also started to establish strong business relationships with some of the hundreds of biopharmaceutical companies located within the country. Particular attention has been paid to clusters including Dômes Pharma, Lyon bio pôle (both Auvergne-Rhône-Alpes) and Polepharma (Normandie + Centre).

As I enter my third year working for Rephine, I am proud at the progress that has been made in establishing the company within the French marketplace. I am also acutely aware that there remains a lot of untapped potential for the company to continue to grow in France and I look forward to planning my next trip to the country for Q1 2017.

If you are interested in learning more about Rephine’s services, please feel free to contact me using the following email address: [email protected]