Should Transfers of Value to patient organisations be disclosed on Disclosure UK?

Clause 24 - Transfers of Value to Health Professionals and Healthcare Organisations

24.1 Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals and healthcare organisations located in Europe.

• Guidance

• Supplementary information Clause 24.1 Transfers of Value

The term ‘transfer of value’ is defined in Clause 1.10. The term ‘Europe’ comprises those countries that are within the EU and other countries with a trade association that is a member of EFPIA. 

The term ‘health professional’ in relation to disclosure of transfers of value also includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional as defined in Clause 1.4.

Disclosure is required even if the payments etc are made by overseas affiliates, head offices in the UK or overseas and UK based offices.

• Clause 24.1 Consent to Disclosure
• Clause 24.1 Mode of Disclosure
• Clause 24.1 Date of Implementation
• What should pharmaceutical companies do if a health professional/HCO donates their transfer of value to a third party, eg a charity, charitable trust or other institution?

24.2 The transfers of value covered by Clause 24.1 are

• joint working in accordance with Clause 20
• donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Clauses 19.1 and 19.2
• contracts between companies and institutions, organisations and associations in accordance with Clause 21
• sponsorship of attendance by health professionals and other relevant decision makers at meetings in accordance with Clause 22.5
• fees and expenses paid to health professionals and other relevant decision makers, or to their employers on their behalf, in accordance with Clauses 23.2, 23.3 and 23.4
• contributions towards the costs of meetings paid to healthcare organisations or to third parties managing events on their behalf, which may include sponsorship of health professionals by way of registration fees and accommodation and travel.

Supplementary information Clause 24.2 Further Information

24.3  Clause 24.1 does not apply to transfers of value to patient organisations. These transfers of value are covered by Clauses 27.7 and 27.8.

24.4 Disclosures must be made annually in respect of each calendar year. Disclosure must be in the first six months after the end of the calendar year in which the transfers of value were made.

24.5 The information disclosed must remain in the public domain for at least three years from the time of disclosure.

24.6 Companies must document all disclosures and retain the records for at least five years after the end of the calendar year to which they relate.

24.7 Different categories of transfers of value to individual health professionals can be aggregated on a category by category basis, provided that itemised disclosure would be made available upon request to the relevant recipient or the relevant authorities.

Payments to healthcare organisations are required to be disclosed on a per activity basis.

24.8 Where a transfer of value is made to a health professional indirectly via a healthcare organisation such a transfer should be disclosed once only, preferably as being a transfer to the health professional.

24.9 Where recipients of transfers of value cannot be identified for legal reasons, the amount attributable to such transfers must be disclosed on an aggregate basis. The number of recipients involved must be stated together with the percentage of all recipients that they represent and the aggregate amount attributable to transfers of value to such recipients.

• Supplementary information Clause 24.9 Disclosure of Transfers of Value to Individuals

24.10 Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.

 

Clause 27 - Relationships with Patient Organisations

27.1 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.

Companies must respect the independence of patient organisations.

• Supplementary information Clause 27.1 Other Codes and Guidelines

There are other codes and guidelines which cover patient groups, including Charity Commission requirements.

27.2 When working with patient organisations, companies must ensure that the involvement of the company is made clear and that all of the arrangements comply with the Code. This includes the need to declare sponsorship (Clause 27.9) and 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.

• Supplementary information Clause 27.2 Purpose of Materials and Activities   Clause 27.2 Hospitality for Carers

27.3 Companies working with patient organisations must have in place a written agreement setting out exactly what has been agreed, including funding, in relation to every significant activity or ongoing relationship.

• Supplementary information Clause 27.3 Written Agreements
• Advice
• What material relating to working with patient organisations requires certification?

27.4 No company may require that it be the sole funder of a patient organisation or any of its programmes.

27.5 A company must not make public use of a patient organisation’s logo or proprietary material without the organisation’s written agreement. In seeking such permission, the specific purpose and the way in which the logo or material will be used must be clearly stated.

• Supplementary information Clause 27.5 Use of Patient Organisation Logos or Material

27.6 A company must not seek to influence the text of patient organisation material in a manner favourable to its own commercial interests. This does not preclude a company from correcting factual inaccuracies.

27.7 Each company must make publicly available, at a national or European level, a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support, which must include a description of the nature of the support that is sufficiently complete to enable the average reader to form an understanding of the significance of the support. The list of organisations being given support must be disclosed annually in respect of each calendar year. Disclosure must be in the first six months after the end of the calendar year in which the transfers of value were made.

The published information must include the monetary value of financial support and of invoiced costs. 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.

• Supplementary information Clause 27.7 Further Information  

27.8 Contracts between companies and patient organisations under which they provide any type of services to companies are only allowed if such services are provided for the purpose of supporting healthcare or research.

Patient organisations may be engaged as experts and advisors for services such as participation at advisory board meetings and speaker services. The arrangements that cover consultancy or other services must, to the extent relevant to the particular arrangement, fulfil all the following criteria:

• a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services
• a legitimate need for the services must be clearly identified and documented in advance of requesting the services and entering into the arrangements
• the criteria for selecting services must be directly related to the identified need and the persons responsible for selecting the service must have the expertise necessary to evaluate whether the particular experts and advisors meet those criteria
• the extent of the service must not be greater than is reasonably necessary to achieve the identified need
• the contracting company must maintain records concerning, and make appropriate use of, the services
• the engaging of patient organisations must not be an inducement to recommend a particular medicine
• the compensation for the services must be reasonable and not exceed the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating patient organisations
• in their written contracts with patient organisations, companies are strongly encouraged to include provisions regarding an obligation of the patient organisation to declare that they have provided paid services to the company whenever those concerned write or speak in public about a matter that is the subject of the agreement or any other issue relating to that company
• each company must make publicly available, at a national or European level, a list of patient organisations that it has engaged to provide significant contracted services, which must include a description of the nature of the services provided that is sufficiently complete to enable the average reader to form an understanding of the arrangement without the necessity to divulge confidential information. Companies must also make publicly available the total amount paid per patient organisation over the reporting period. The list of organisations engaged must be updated at least once a year.

Supplementary information Clauses 27.7 and 27.8 Transfers of Value to Patient Organisations  Clause 27.8 Consultancy Services Provided by Patient Organisations

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