3. Scope and topics of codes of conduct

1. Scope and topics of codes of conduct

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

Using the EFPIA code of practice [1] as example, the following section will consider the scope and topics of codes of conduct in more detail.

The EFPIA Code applies to activities relating to prescription-only medicines (POM) (whether patented or off-patent, branded or generics). This is similar to the scope of the EU Pharma Regulation (Directive 2001/83/EC of the European Parliament and of the Council as amended, relating to medicinal products for human use). The Codes are applicable to all activities relating to POM and relationships with Healthcare Professionals (HCP), Healthcare Organisations (HO) and Patient Organisations (PO) (as defined in the Codes, and excluding commercial activities).

1.1. Combination of ethics and rules of behaviour

As already indicated, most codes of conduct contain both, an organisation’s ethics policy and rules of behaviour and practices. This is confirmed by the IFPMA Global Code Comparison survey: the number of member associations that integrated the IFPMA Ethos in their code was 42 out of the 46 respondents. This underlines the move away from a rules-based approach to a code based on ethical values and principles. This is also reflected in the EFPIA code.

The EFPIA code in its Preamble lists the ethical principles and in Annex 2 gives examples. [The principles are overarching, binding for all following rules of behaviour and applicable towards all stakeholders]
(list with selected topics shown from both, Preamble and Annex 2):

PATIENTS ARE AT THE HEART OF WHAT WE DO. We aspire to ensure that everything we do will ultimately benefit patients.

INTEGRITY, we interact in a responsible manner and aim to ensure that our communications with stakeholders are accurate, legitimate and balanced.

RESPECT. We interact with all our stakeholders with respect. We value the importance of independent decision-making by stakeholders, based on evidence and including patient interest. We follow applicable laws and make ethical judgements when processing Personal Health Data.

TRANSPARENCY. In order, to continue to be successful, self-regulation needs to respond to the evolving demands of society. In particular, EFPIA recognises the growing expectation that interactions with society are not only conducted with integrity but are also transparent. We are open about our activities and interactions and encourage stakeholders to act with the same openness.

1.2. Overview of scope

In Essence, the EFPIA Code covers (abbreviated details in brackets):

• Promotion of Prescription Only Medicines (POMs) to HCPs,
(all methods of Promotion including, oral and written, journal and direct mail advertising, the activities of Medical Sales Representatives, digital communications and channels, such as websites and social media, audio-visual systems such as films, video recordings, data storage services and the like. It also covers the provision of Informational or Educational Materials, Items of Medical Utility, hospitality in relation to Events and Medical Samples)

• Interactions between Member Companies and HCPs, HCOs,
(including those in the context of research or contractual arrangements (incl. non-interventional studies as well as consultancies and advisory boards).

• Interactions between Member Companies and POs,

• Disclosure of ToVs from Member Companies to HCPs, HCOs and POs; and

• Procedural requirements of the EFPIA Code.

Member Companies are responsible for the obligations imposed under any relevant Applicable Code (includes national codes based on the EFPIA code) even if they commission a Third Party to design, implement or engage in activities covered by the Applicable Code on their behalf.

The EFPIA Code is not intended to restrain or regulate activities directed towards the general public which relate solely to non-prescription Medicinal Products.

The EFPIA Code does not cover:

• the items contained in the provisions of Article 86 (2) of Directive 2001/83 (listed), except ‘information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products’ (See also Lesson 2 Advertising and promotion of medicines to the public and to HCPs)

• activities which relate solely to non-prescription Medicinal Products; or

• non-promotional, general information about Member Companies, including financial data, descriptions of research and development programmes, and regulatory developments

Finally, a set of practical rules is annexed to the code to help national organisations implement these principles in specific national codes including how to process complaints, and to determine sanctions:

The following documents, binding to EFPIA members, are attached to the EFPIA Code:

Annex A  Standardised Disclosure template;
Annex B  EFPIA guidance;
Annex C  Guidance obligations for Member Associations under the EFPIA Code; and
Annex D  EFPIA Standard Operating Procedure related to processing of complaints and questions submitted to EFPIA;

Additional documents to illustrate the provisions of the EFPIA Code and provide explanations for a consistent implementation:

Annex 1  EFPIA recommendation Disclosure “Gateway” on Member Associations Websites
Annex 2  Examples of the ethical principles

1.3. Overview of Topics by chapter

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)]