IPHA Perspective on Transfer of Value Disclosure Queries

The shared ambition of IPHA member companies is to make available life-enhancing medicines including vaccines, for patients in Ireland via those entitled to prescribe and supply. In relation to this, collaboration between industry and Health Care Professionals (‘HCP’) benefits patients. It is a relationship that has helped deliver numerous life-enhancing medicines and changed the way many diseases impact on our lives.

This relationship is based on an exchange of information. Activities can range from conducting clinical research to sharing best clinical practice and exchanging information on how new medicines fit into the patient pathway. In this respect, HCPs may receive support to attend educational meetings such as congress registration fees, travel and accommodation*. HCPs may also provide expertise and insight by attending advisory boards, speaking at education and training meetings or acting in a consultancy role.

It is important to note that the provision of support to HCPs, is regulated by legislation and the industry self-regulatory Code put in place by IPHA as part of the European association, EFPIA.  This Code reflects, and in some instances, is stricter than the legislation.  It is a condition of membership of IPHA to adhere to the Code, including its disciplinary procedures.  While the Code and legislation permit the promotion of medicines to HCPs there are strict controls around this activity. In particular, the interactions between our industry and HCPs must meet high standards of integrity and transparency.

In addition to requiring our members to adhere to our self-regulatory Code, regulatory inspections of compliance with the legislation by the HPRA are welcomed because they facilitate the development and improvement of high standards.

Since 2017, IPHA has worked to provide increasing transparency in the public reporting of transfers of value between companies and Healthcare Organisations (HCOs) and HCPs.  Since then:

• The Transfer of Value platform has annual returns from over 47 companies, including non-IPHA members.

• 100% of transfers of value to Healthcare Organisations are disclosed with named recipients.

• Within GDPR requirements, we have worked to drive towards full transparency of ToVs to HCPs. The rate of individual disclosure has risen from 64% in 2019 to 96% in respect of 2023 data.
• The Royal College of Physicians in Ireland Guidelines note “that collaboration between industry and RCPI has the potential to deliver significant benefits and that industry plays a valid and important role in the provision of medical education. However, this relationship needs to be based on clear ethical principles and should be transparent”.**
• In a letter from February 2023 the HSE stated how it strongly believes that any ToV received by a HSE employee / HSE Health Care Professional should be disclosed on the ToV. The HSE would not, in general, support a request for non-disclosure. The HSE would, in addition to the above, flag that its distinct preference would be that an individual company should not repeat ToVs to any HSE employed HCP who has refused to allow publication of a previous ToV received from that company unless exceptional circumstances apply.

In line with best practice internationally and mirroring what other countries have implemented, IIPHA has implemented a number of safeguards which would make it more difficult to reuse the data on www.transferofvalue.ie for additional purposes, such as preventing the indexing of the data through search engines and the downloading of this information. According to the Data Protection Commission (DPC) opinion the safeguards put in place by IPHA to implement the principles of data minimisation and to protect the fundamental rights of data subjects, and the implementation of protocols to protect the data from search engine indexing is particularly welcomed. This should ideally mean that the information will only be available to persons who seek to access it for legitimate purposes, and it will be protected from webscraping or other harmful practices. (See the full DPC opinion here).

The R&D ToVs are disclosed in aggregate due to applicable EU and national legislation’s interpretation. Disclosing information about R&D has the potential to compromise confidential information and breach competition laws. Furthermore, Research and Development activities, and in particular clinical trials, are subject to further transparency legislation under the EU Clinical Trial Regulation (2001/20) and the European Medicines Agency Transparency Policy (Policy 0070). Further transparency on R&D is brought by initiatives such as the EU Clinical Trials Register and Innovative Medicines Initiative.

IPHA believes that voluntary disclosure codes which are well-designed and consistently implemented are effective and more quickly adaptable to changing circumstances than primary legislation. IPHA engages with all stakeholders to support public disclosure and is strongly supported by the HSE, medical groups and learned societies.  We are not aware of a significant gap in disclosure requirements that could not be filled using voluntary codes that apply to all Marketing Authorisation Holders and therefore, we are not aware of a clear rationale for the replacement of the IPHA voluntary code with legislation.

*working-together-for-patients-grants-and-donations.pdf (efpia.eu).

**Lifelong-Learning_CPD-Courses-and-Events_Industry-Sponsorship-and-Support_2024.pdf (rcpi.ie)