In its Pharmaceutical Strategy for Europe, the European Commission called for enhancing the resilience and security of supply chains, launching a structured dialogue and a series of consultations in order to come up with practical and reliable solutions. The COVID-19 crisis indeed put the spotlight on long-lasting issues affecting the medicines supply chain, including medicines shortages and the high toll they take on patient chances. The crisis sped up the implementation of solutions at EU level, with the EMA-led SPOC and iSPOC pilots. It was also a test for national regulatory systems.
In the French case, the specific organisation of the chain proved very useful, especially its time-tested network of Single Points of Contacts in the pharmaceutical industry: Chief Pharmaceutical Officers, or CPOs (pharmaciens responsables/PR). As the regulator for the pharmacy profession in France (implementing art. 52 of Directive 2001/83/EC on QP duties control), the Chamber of Pharmacists registers CPOs.
As an institution tasked by law to promote public health and safety of care, we believe sharing this national good practice could be a useful input to European deliberations preparing upcoming legislative proposals.
While detailed organisations should be adapted to national realities according to the subsidiarity principle, the basic concept of single points of contact at industry level might be of interest throughout Europe.
The French experience: a single, central, reliable and efficient point of contact for health authorities
Every pharmaceutical company in France has a Chief Pharmaceutical Officer (CPO) as part of its managers, supervising delegate CPOs to cover each of the company’s structures. By law, the CPO is personally responsible for the compliance of all pharmaceutical activities falling within the scope of the company, in all civil, criminal and disciplinary matters. This means CPOs supervise quality and safety (covering R&D, manufacturing authorisation and quality, unique identifiers, pharmacovigilance, batch monitoring and recall/withdrawal), as well as information (including marketing authorisation submission and updates, information to health professionals and patient associations, advertising), not to forget supply (continued supply, as well as anticipated management of shortages for medicines of major therapeutic interest, on top of wholesale and storage).
In a nutshell, this scheme brings four benefits to authorities:
Simplicity: a single point of contact for any quality and safety matter,
The big picture: a watchman informed at every step of the product life cycle,
Reliability: a health professional taking personal responsibility,
Efficiency: a manager with authority on all pharmaceutical operations.
The pandemic crisis indeed showed how this responsive scheme helps authorities to act. For example, when ICU units were hit hard by medicines shortages, authorities were able to direct notifications by hospital pharmacists of ICU needs directly to these key managers. French CPOs were also responsible for the iSPOCs for the European Medicines Agency.
Moreover, they were empowered to identify the critical/essential medicines, as well as their security stocks and contingency plans.
Securing medicines quality, safety and supply at EU level: a European SPOC network of physical persons with a comprehensive view
Directive 2001/83/EC currently does not foresee a continuous SPOC network of responsible persons in the industry. For example, it requires manufacturers and importers to have one or several qualified person(s) with some responsibility, but marketing authorisation holders have a qualified person only for pharmacovigilance and (by default) at EU level. No specific person is responsible for the all-important obligation of continued and appropriate supply. Companies do not have a single point of contact for key compliance matters. In contrast, Regulation (EU) 2017/745 recently introduced a single Person responsible for regulatory compliance in the field of medical devices.
The upcoming revision of directive 2001/83/EC is an opportunity to create a SPOC network throughout the chain, at EU and national level. Making these SPOCs physical, responsible persons, orchestrating the key quality, safety and supply activities in their companies could foster efficiency and much-needed anticipation. It would actually contribute to several of the goals set by the Pharmaceutical Strategy for Europe: ensuring supply, improving efficiency, enhancing safety and patient-centered care.
For example, having such compliance SPOCs for the market life of the product, including European public service obligations and early notification of market withdrawal, would improve the detection and mitigation of shortages, while giving both authorities and patient associations a responsive interlocutor.
Another advantage experienced in France is that such responsible persons would be able to connect the dots between pharmacovigilance signals, variations and complaints so as to make quicker decisions about the market withdrawal of a medicinal product.
That is why it could be worth exploring the introduction of a person responsible for end-to-end regulatory compliance in all pharmaceutical companies. Having a continuum of responsibilities for quality and safety within the chain has the potential both to improve processes for the industry and health authorities, and to close in on the primary goal of such processes: bringing the best possible service to patients.