3. Scope and topics of codes of conduct

The code text is organised in 6 Chapters, articles within chapters and sections within articles with provisions of increasing level of detail. Selected examples are given below.

Chapters 1, 2 and 3 reflect and follow closely the requirements of Council Directive 2001/83/EC. They fit into the general framework established by the Directive, which, notably, recognises the role of voluntary control of advertising of Medicinal Products by self-regulatory bodies and recourse to such bodies when complaints arise (Directive 2001/83 Article 97 (5)) (See below Chapter 6)

Chapter 1. Promotion of POM to HCPs:

- refers to the prohibition of promoting medicines that do not have a marketing authorisation. (Art. 1)
To note: European and national laws and regulations prohibit the advertising of POM to the general public (direct-to-consumer advertising (DTCA) of POMs).

- details the rules in terms of nature (mandated content, accuracy, substantiation, sources/references, prohibition of misleading promotion, etc.) and distribution (addressees, transparency-no disguised promotion, etc.) of promotion and, in part, scientific information. Artl. (2 - 9)

To note: Art. 5 specifically deals with the ‘Acceptability of promotion’ and states: ‘Member Companies must maintain high ethical standards at all times. Promotion must:

(a) never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry;

(b) be of a nature which recognises the special nature of Medicinal Products and the professional standing of the intended audience; and

(c) not be likely to cause offence.

Chapter 2. Interactions with HCPs, HCOs and POs:

- addresses events and hospitality, demanding that event locations be “appropriate”, i.e., not “extravagant” and hospitality offered be likewise “appropriate” and “reasonable” in level and strictly limited to the main purpose of the event. (Art. 10)

- specifies that gifts leading to a personal benefit are prohibited, whereas appropriate support of HCPs or POs’ Representatives to attend events, subject to applicable code(s) is permitted (Artl. 11, 13)

- provides strict rules considering Donations and Grants to HCOs and/or POs (only allowed for supporting healthcare, research or education; are documented and kept on record, are no inducement to promote specific medicines, are prohibited for individuals, also no single company can be funder or sponsor for a PO or HCO but broad funding by Member Companies welcome). (Artl. 12, 14)

- gives detailed instructions as to contractual services/consultancy by HCPs, HCOs, POs or POs’ Representatives, such as speaking at/chairing meetings, involvement in medical/scientific studies, training services, advisory boards (e.g., legitimate need for the services has been clearly identified, compensation must be reasonable and reflect the fair market value, services are documented and kept on record, are no inducement to promote specific medicines)

[An ever-increasing area is the consulting services provided to pharmaceutical companies by patient organisations or their members. Historically it has been shown that independent patient organisations provide more unbiased and reliable advice than individuals. One current practice is for multiple stakeholders to establish independent patient advisory boards for specific disease areas rather than for a trial or a company. Examples of this can be found in the European Community Advisory Board[1] and additional guidance for Community Advisory Boards (CABs) from the PARADIGM IMI project[2] ]

Chapter 3. Specific Requirements for Interactions with HCPs and HCOs:

- concerns medical education and educational material (incl. items of medical utility) which should aim at increasing the scientific knowledge and competence of HCPs and must not constitute promotion or a “gift” or inducement for a specific medicine. (Artl. 16, 17) includes Non-Interventional Studies (NIS) and sets out the criteria for their conduct (Art. 18)

- addresses free medical samples of prescription-only medicines which should only be given on an “exceptional basis” and in response to a written request from HCPs qualified to prescribe that particular medicine. As in directive 2001/83 (Art. 96) it is acknowledged that the situation may vary according to national regulations. (Art. 19)

- pays specific attention to the member company staff, which must be proficient in the relevant requirements of the applicable code(s) and laws and regulations, and this specifically applies to sales representatives who must be adequately trained and have sufficient scientific knowledge to be able to provide precise and complete information about the medicines they promote (Art. 20)

Chapter 4. Specific Requirements for Interactions with POs:

- reiterates the ethics principles of independence of POs, mutual respect, transparency, and that EU and national laws and regulations prohibit the advertising of POM to the general public. It regulates issues such as mandatory written agreements when providing financial or indirect support, and editorial corrections in patient organisations’ material (Art. 21)

Chapter 5. Disclosure of ToVs from Member Companies:

- details the rules for disclosure of ToV which member companies have to transpose into their National Codes except where they would be in conflict with applicable national laws or regulations. It also lists exclusions from disclosure such as ToVs that are only related to over-the-counter medicines (Artl. 22 – 24)

Chapter 6. Procedural Requirements:

- covers implementation of and compliance with the code, including derogations especially where more stringent disclosure requirements exist (Artl. 25 – 28)

- refers in considerable detail to how to receive and process complaints and to apply sanctions when an entity does not respect the code (Art. 28). Complaints may be lodged either with a Member Association or with EFPIA although enforcement and adjudication of complaints and the initiation or administration of sanctions is entrusted to member associations. The process used by EFPIA is set out in a standard operating procedure (Annex D).

[In this context it is worth to remember that addressing infringements of title VIII of Directive 2001/83, self-regulation based on Art. 97 of the Directive (and by extension on Art. 99 as regards penalties), is explicitly allowed for self-regulatory bodies. These processes therefore are a safeguard to the integrity and transparency of industry interactions with society and a means to build trust. (See also Lesson2 Advertising and promotion of medicines to the public and to HCPs)]