A complex environment
From support to pillar functions, pharmaceutical activities must develop an integrated model at French local level to cover the full scope & responsibilities of a Chief Pharmaceutical Officer (CPO) on an Exploitant[1] site in France. The COP roles are different from the EU Qualified Person roles, with a wider range of responsibilities for the CPO. (See Figure 1)
The CPO, as a Responsible Pharmacist, should be able to independently take any decision regarding the pharmaceutical products and activities of the company, in accordance with the requirements of the Public Health Law and of the applicable Good Practices. [1]
Figure 1: Status and responsibilities of a Chief Pharmaceutical Officer in France
The CPO oversees all pharmaceutical activities performed on the French territory (See Figure 2), including:
- Regulatory Affairs (MAs, advertising & labelling),
- Safety (Pharmacovigilance),
- Medical information,
- Exploitant Quality Management System,
- Supply Chain monitoring & relationship management with manufacturing and distribution sites,
- Pharmaceutical Sales Representatives management,
- Clinical trials oversight on the French territory (if any),
- Batch tracking and record if needed.
The CPO must have a robust local Quality Management System (QMS) allowing oversight, monitoring & governance of all pharmaceutical activities.
Figure 2: The Responsible Pharmacist scope of an Exploitant site in France
The CPO’s scope is growing in complexity, in a continuously evolving environment for pharmaceutical activities driven by the following trends: (See Figure 3)
- International and European regulations standards have increased the reinforcement of corporate & global organizations with a verticalization of functions. European structures are created & roles and responsibilities are redefined between these new structures and the French affiliates.
- For example, market access may be now handled by the corporate / European structures.
- Most European countries manage manufacturing and operations only through a European network of Qualified Persons (QP, EU QP PV, etc.), based on qualifying expertise.
- Formalized and professional agreements are concluded to detail operating models between the corporate/MA holder and affiliate (ex: technical agreements, SDEA clarifying roles and responsibilities)
- Internationalization of inspection practices from various regulatory authorities have created alignment of internal requirements to comply with the highest standards. For example, Safety is subject to increasingly targeted and precise inspections carried by competent authorities following a serious safety crisis in France (e.g. Mediator). The judicialization of these crises and the reinforcement of European and French requirements have made Safety a very critical function. Any deviation or problem can potentially damage durably a company's image. Pharmacovigilance activities must therefore be perfectly controlled within the framework of a clear and formalized relationship between the corporate/MA holder and the affiliate, particularly with the CPO in France.
- Internationalization and complexification of the manufacturing & distribution chain from the purchase of raw materials to the final customer. Subcontracting these activities has widely developed over the last years, while quality and traceability requirements have continued to increase under the responsibility of the CPO in France. This implies a system of well-defined technical agreements, the organization of regular audits and the support of validated IT tools. The CPO must master these cascades of agreements and manage the control of the subcontracted activities, employing appropriate audit systems, with the support of corporate.
- Pharmaceutical Sales Representative Certification exposes the CPO to Sales & MSL activities. The continuous strengthening of regulations around sales representatives & MSL activities reinforces the co-responsibility of the CPO and the affiliate General Manager on their compliance to the legal requirements. Moreover, the control of advertising by the CPO must evolve with an intervention as far upstream as possible on the overall campaigns in close partnership with the marketing and medical functions.
- Innovation is everywhere. Innovation has important strategic consequences, hence the need to develop new regulatory expertise to anticipate future needs for example. It is an opportunity for the CPO and for teams to play an upstream advisory role instead of a downstream control or a blockade situation. Examples of topics which need the involvement of the CPO and its teams: new methods of prevention and diagnosis, new dispensing practices, profound changes in the manufacturing chain (targeted therapies), the complexity of medical devices, patient centered focus strategies, digital and e-health.
Figure 3: Key trends shaping the future of pharmaceutical activities
[1] An Exploitant entity is responsible for the marketing of medicinal products on the French territory, making it reliable for duties relative to the marketing authorization holder (Dir. 2001/83/EC of Nov 6th, 2001). The Exploitant status does not exist at European level and should be distinguished from the wholesale distributor status.
Authors:
- Corinne de Villeneuve, Director, Life Sciences
- Francoise Robinet, French Pharmaceutical advisor
- BearingPoint Life Sciences team