The new Charter for the Quality of Professional Practices1 for Medical Devices companies - called “QPP Charter” in this article - was published in the Official Journal in France on March 2022 and covers the practices of persons responsible for the presentation, information, or promotion of medical devices.

While the QPP Charter is already effective, as of today (November 2022) there is no information yet on the certification process and deadline. The certification referential is expected to be published by March 2023 by the French Health Authority (HAS).

To draw the parallel with the QPP Charter for medicinal products, new pharmaceutical companies were requested to obtain their QPP certification in the 9 months following the beginning of their promotional activity, and financial sanctions for non-compliance could reach up to 10% of the company annual revenue for the product in France2. That should set the tone for MD companies: you better get ready as soon as possible and not wait for the referential to be published to initiate the change!

We will review in this article QPP Charter application framework, highlight the key challenges for MD companies and propose levers to ensure proper readiness. First advice: never underestimate the impact of a local regulation on the global organization of the company, including its mindset.

1/ QPP Charter: what and for who?

The QPP Charter is completing the existing regulatory framework for Medical Devices (MD):

  • In EU: the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation (MDR/IVDR) published in May 2017 and fully applying from May 20213
  • In France: the Public Health Code and the Consumer Code (CSP), the guidelines issued by the French National Agency for the Safety of Medicines and Health Products (ANSM) completed in 2020 with the anti-gift law4 (read our previous article here).

It applies to:

  1. Medical Device companies (distributor or importers), signatories of an agreement with the French economic committee for health products (CEPS) and having a promotional information activity in general medicine, in health institutions or medico-social institutions, for at least one product or service mentioned in the list provided in Article L. 165-1 of the French Code of Social Security (CSS)
  2. Subcontracting companies carrying out a promotional information activity on behalf of a certified operating company

The QPP Charter scope is transversal to Sales, Marketing & Medical functions (in headquarters and on the field) and also impacts Market Access, Training, IT & Quality, Supply Chain and HR departments, depending on the company organization. Its proper application is under the responsibility of the Compliance, Legal and Regulatory departments (figure 1).

Figure 1: key stakeholders impacted by the QPP Charter

2/ Key changes brought by the QPP Charter

The overall objective of the QPP Charter is to better regulate Sales & Marketing activities and promotional material, as it could threaten the quality of care or lead to unjustified expenditures for French health insurance. It is reminded in the Charter that MD companies must be able to measure and control their actions contributing to the product good use and to the detection of non-conform prescriptions.

Here are the key concepts introduced by the QPP Charter:

  • Limit of 4 visits per year per product per healthcare professional or healthcare structure. This threshold may be revised by the Monitoring Observatory Center that will be created with the Charter
  • Anticipation, organization, and official scheduling and follow-up for visits
  • Quality of the information provided during visits, which should include but not only: established and valid data justifying any results/attributes of the product, precaution of use, side effect & contraindication, regulatory & scientific aspects, CE marking, information about health insurance reimbursement, good use campaign, materiovigilance, available unbiased studies, etc.
  • Respect of business ethics by field forces: don’t incite professionals, respect professional secrecy for patients, don’t interfere with the dispense of care, don’t contact patients, don’t meet students, respect the HCP structure rules & access, don’t run survey, or collect data from the structure, etc.
  • Continuous training of field forces, including on QPP Charter, with periodic evaluations
  • Quality control procedures securing promotional material used by field forces, their modality of use and authority validation (if needed), as well as the archiving for 5 years of any material used during visits
  • Declaration of all visits* annually in a new CEPS platform (under preparation), included visit nature, list of beneficiaries, date, modalities, list of support & samples shared, etc.

Figure 2: QPP Charter, what is in it? 

* Excluding visits to discuss training, technical support, materiovigilance, tenders, visit requested by the beneficiary, claims/complaints…

3/ Comply with QPP Charter: where to start?

The MD QPP Charter certification referential will be close to the QPP certification referential for the promotion of medicinal products. Companies already certified for medicinal products have the advantage of having already a good idea of the transformation effort and team required for QPP implementation, as well as a quality system already implemented.

How to move forward implementing the QPP Charter and getting ready for the certification?

MD companies’ requirements can be summarized in 3 main categories of actions:

Adjust procedures, processes & documentation:

  • Assess impacts on the following procedures and update them accordingly: procedure for Advertising, Positive list, Anti-gift low and Transparency, Materiovigilance, Training, Samples, etc. and potential need for the creation of new procedures
  • Identify the information required for the annual declaration to CEPS and thus associated forms, documents to create, and information and data to collect and clean

Adjust SI & IT environment:

  • Assess impacts on local & global tools such as: Regulatory & Compliance tools, promotional material management tools, digital marketing tools, training tools, CRM, inventory stock management tools for the positive list and destruction…
  • Secure and anticipate the annual declaration of visits in the CEPS platform (to be fined tune when the CEPS platform will be made available): data standards, possible API, internal validation flow, etc.

Ensure proper training and adoption of the new mindset and way of working:

  • Identify the new ways of working for your Sales & Marketing team (and every teams in charge of promotion and information)
  • Prepare, coach & train them regularly, generate a mindset shift for a sustainable transition of the behaviors in compliance with the QPP Charter vision

4/ Success factors for a smooth and sustainable transition to QPP Charter

Figure 3: Three success factors for the transition to QPP Charter

QPP Charter should not be underestimated by MD companies: depending on each organization, this French regulation may have significative impacts on business, on global processes and global tools.

On top of that, QPP Charter adds complexity in a tense regulatory context for medical devices, with a lot of companies still struggling with their MDR certification.