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The 2011 Code required financial details of sponsorship of UK health professionals and appropriate administrative staff to attend meetings organised by third parties to be made publicly available in respect of sponsorship to attend meetings in 2012 and each calendar year thereafter. The 2014 Code introduced different requirements which applied to both meetings organised by third parties and those organised by pharmaceutical companies. The previous requirements in the Second 2012 Code applied only to meetings organised by third parties.

Disclosure of attendance at meetings in 2015 and each calendar year thereafter is required. Disclosure of 2015 data is required in 2016 (Clause 22.5 and its supplementary information). Disclosure must be carried out in accordance with Clause 24.

For disclosure in relation to calendar years 2013 and 2014 the requirements and procedures in Clause 19.4 and its supplementary information in the Second 2012 Edition of the Code still apply.

26) The Use of Consultants

Health professionals and other relevant decision makers may be used as consultants and advisors for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The arrangements which cover these genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfil the criteria set out in Clause 23 and procedures should ensure that the requirements of that clause are complied with.

Changes were made in relation to the use of consultants in the 2011 Code. In particular, public disclosure of fees paid to consultants in the UK for certain services was required for payments made in 2012 and each calendar year thereafter (Clause 20.2). No disclosure was required in relation to payments for research and development work, including the conduct of clinical trials. Additional information was required to be disclosed in relation to certain payments made in 2013 and each calendar year thereafter (Clause 20.3).

The 2014 Code made significant changes in relation to transfers of value to consultants including disclosure on a named individual basis. Transfers of value in relation to research and development work (including the conduct of clinical trials) are to be disclosed on an aggregate basis.

These new requirements apply to data for 2015 and each calendar year thereafter. The data for 2015 is to be disclosed in 2016. Disclosure must be carried out in accordance with Clause 24. There is much detail in the supplementary information to Clauses 23.2 and 23.3. For disclosures in relation to calendar years 2013 and 2014, the requirements and procedures in Clauses 20.2 and 20.3 and their supplementary information in the Second 2012 Edition of the Code still apply. Contracts or agreements with consultants entered into or renewed on and after 1 May 2011 must include provisions regarding their obligation to declare the arrangement whenever they write or speak in public about the subject of the agreement or any issue relating to the company (Clause 23.1).

27) Transfers of Value

Transfers of value to health professionals, other relevant decision makers and healthcare organisations must be disclosed (Clause 24). The term ‘transfer of value’ is defined in Clause 1.10 and the supplementary information to Clause 1.10 lists a number of matters which are not transfers of value for the purposes of the Code. Clause 24.2 lists transfers of value covered by Clause 24.1. Transfers of value to patient organisations are not covered by Clause 24. These transfers of value continue to be covered by Clauses 27.7 and 27.8.

The matter is complicated as far as the Code is concerned by the fact that it already had disclosure requirements, some of which have been superseded by the requirements derived from the EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations. The requirements involve the disclosure of 2015 data and each calendar year thereafter. The 2015 data is to be disclosed in 2016. Disclosure requirements in relation to calendar years 2012, 2013 and 2014 continue to apply.

Disclosures must be made in accordance with Clause 24.

Companies must disclose using the central UK platform and a standard template (supplementary information to Clause 24.1).

Companies should take steps to ensure that they will be able to readily source the information to be publicly disclosed.

Each company must publish a note summarising the methodology used to prepare the disclosure and identifying each category of transfer of value.

Procedures should ensure that the methodological note includes:

l a general summary and/or country specific

considerations

l the approach used

l how multi-year contracts, VAT, currency aspects

have been treated.

The ABPI data sharing agreement must be signed by each company disclosing its transfers of value on the UK central platform. Arrangements for uploading the data and checking it with health professionals and healthcare organisations can be obtained from the ABPI.

28) Scientific Services

Companies must ensure that they have an identifiable scientific service to compile and collate all information, from medical representatives or any other source, about the medicines which they market (Clause 25.1). Where relevant, they must also have a scientific service to deal with the approval and supervision of non-interventional studies (Clause 25.2). There can be one scientific service in charge of both responsibilities or separate services with clearly delineated duties.

29) Relations with the Public and the Media

Prescription only medicines must not be advertised to the public but information about them can be provided either directly or indirectly. The provision of information to the public about prescription only medicines must be in accordance with Clause 26. The introduction of a new medicine should only be made known to the public after reasonable steps have been taken to inform relevant health professionals of its availability.

Any material which relates to a medicine and which is intended for patients taking that medicine must include a statement relating to the reporting of side effects. If the medicine is one which is subject to additional monitoring, then the material must include an inverted black equilateral triangle and an additional statement (Clause 26.3).

30) Relationships with Patient Organisations

Pharmaceutical companies can interact with patient organisations or any user organisation such as disability organisations, carer or relative organisations and consumer organisations to support their work, including assistance in the provision of appropriate information to the public, patients and carers (Clause 27).

When working with patient organisations, companies must ensure that all of the arrangements comply with the Code. This includes the prohibition on advertising prescription only medicines to the

public (Clause 26.1). The requirements of Clause 22, which covers meetings for health professionals and other relevant decision makers, also apply to pharmaceutical companies supporting patient organisation meetings.

Companies must ensure that the requirements of Clause 27 are complied with when working with patient organisations. In particular, written agreements must be in place in respect of every significant activity or ongoing relationship (Clause 27.3) and there has to be public disclosure of financial support or indirect/non-financial support. The published information must include the monetary value of financial support and of invoiced costs (Clause 27.7). For significant non-financial support that cannot be assigned a meaningful monetary value, the published information must describe clearly the non-monetary value that the organisation receives.

Companies must ensure that their support is clearly acknowledged from the outset. The wording of a declaration of sponsorship must accurately reflect the nature of a company’s involvement.

Contracts under which patient organisations provide consultancy or other services to companies are subject to the Code. Clause 27.8 specifies the criteria which contracts for such services must meet, to the extent relevant to the particular arrangement. A list of patient organisations that have been engaged to provide significant contracted services must be published and updated at least once a year. Companies should ensure that such contracts comply with the criteria in Clause 27.8.

Hospitality can be provided in certain circumstances to patient carers (supplementary information to Clause 27.2).

31) The Internet

Companies should ensure that all relevant requirements of the Code, including Clause 28, are complied with in relation to promotional material for prescription only medicines which is provided on the Internet and directed to a UK audience. If access to such material is not limited to health professionals and other relevant decision makers, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections clearly separated and the intended audiences identified.

Material intended for the public which is provided on the Internet must comply with Clause 26.2.