Kieran O'Donnell (Limerick City, Fine Gael)

I move amendment No. 1:

To delete all words after “That” and substitute the following: "Dáil Éireann resolves that the Healthcare (Transparent Payments) Bill 2022 be deemed to be read a second time this day twelve months, to allow the Joint Committee on Health and the Department of Health to consider matters further.".

I acknowledge the intention behind this Bill and thank the Deputies for raising such an important matter. I am taking this matter on behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill.

Transparency in the relationship between the pharmaceutical and medical devices industries and healthcare professionals and healthcare organisations is of great importance. The Government agrees with the general principles of this Bill. There should be transparency in transactions between commercial interests and healthcare providers. This is so the public can be assured patient care is based solely on clinical evidence and experience and is in the best interests of patients and their safety.

Payments or other financial supports between the pharmaceutical industry companies, commonly known as market authorisation holder, MAH, companies, to healthcare providers, HCPs, or healthcare organisations, HCOs, are referred to as transfers of value by the industry. Such financial supports are common both in Ireland and abroad. These transfers have had a positive impact on our healthcare system and benefit patients and the public by advancing medical research, conducting clinical trials and ultimately delivering numerous innovative medicines. It is important that such partnerships continue. However, transfers of value can create conflicts of interest, and I understand that some international research has linked them to higher prescribing rates, higher costs and lower prescribing quality.

This Bill seeks to enhance transparency by establishing a statutory register of transfers of value. The Government is not opposing the Bill as enhanced transparency is ultimately aimed at protecting the public. However, transparency is only one way of ensuring accountability, minimising and eliminating conflicts of interest and thus ensuring the best care possible. There is already a suite of measures in place designed to ensure transparency, accountability and public disclosure while minimising conflicts of interest, which measures I will now outline across four broad areas.

First, there are the Medicinal Products (Control of Advertising) Regulations 2007, which are enforced by the medicines regulator, the Health Products Regulatory Authority, HPRA. The HPRA operates an advertising surveillance programme to ensure compliance with the regulations. The HPRA’s monitoring of the giving of moneys or support by pharmaceutical companies to healthcare professionals and healthcare organisations falls within the remit these regulations, via regulation 21, which relates to inducements and hospitality. If breaches are identified by the HPRA through the different elements of its advertising surveillance programme, including during inspections, the HPRA takes appropriate follow-up action with the MAH company to address those breaches.

Second, there are the Ethics in Public Office Acts 1995 and 2001, as amended, which require HCPs in designated public positions or directorships to disclose interests that could influence their official duties. Sections 17 and 18 of the 1995 Act and section 11 of the 2001 Act mandate the disclosure of material interests. This act requires HSE employees at or above grade VIII salary, which is €81,144, to declare interests that could influence their duties. Examples of declarations include: occupational income over €2,600 from non-HSE sources; travel, accommodation and meals funding; shareholdings over €13,000 or 5% of a company; or gifts, property or services over €650.

For public health employees outside the remit of this Act, section 17 of the HSE's national financial regulations prohibits all employees from receiving benefits or hospitality that could compromise integrity. Nominal benefits must be disclosed to their line managers. In addition, the code of practice around the governance of State bodies advises against giving and receiving gifts or benefits that could affect judgement and that could reasonably give cause or be perceived to cause a conflict of interest.

Third, there are professional codes of conduct and ethics for healthcare practitioners. While HSE employees have obligations under the Ethics in Public Office Act, many healthcare professionals are not HSE employees. However, across the regulated professions, there are codes of conduct and ethics in place. These codes of practice set standards for conduct, and include stipulations such as the following: professionals must avoid entering into agreements that may result in actual or perceived conflicts of interest; manage and declare conflicts of interest; not accept inducements, financial or otherwise, or incentives that could reasonably be perceived as affecting their professional judgement for reasons of personal or commercial benefit; and must not accept any gifts or favours from healthcare pharmaceutical companies or patients and that could reasonably give cause or be perceived to cause a conflict of interest. For example, codes of conduct across professions include: the Medical Council's Guide to Professional Conduct and Ethics for Registered Medical Practitioners; the Nursing and Midwifery Board of Ireland’s Code of Professional Conduct and Ethics for Registered Nurses and Midwives; the Dental Council’s Code of Practice relating to: Professional Behaviour and Ethical Conduct; the Pharmaceutical Society of Ireland's Standards and Ethics for Pharmacists; and CORU's Codes of Professional Conduct and Ethics for its regulated professions.

I will outline the voluntary pharmaceutical industry's self-regulation codes of practice. There are two main pharmaceutical trade bodies in Ireland, the Irish Pharmaceutical Healthcare Association, IPHA, and Medicines for Ireland, MFI. They operate a disclosures system for their members. IPHA represents pharmaceutical companies that manufacture or supply originator or on-patent medicines. MFI is a pharmaceutical industry body that represents member companies which manufacture non-patent medicines such as generic, biosimilar or value-added medicines. Members of both IPHA and MFI must disclose financial interactions with healthcare professionals and healthcare organisations, HCOs. Examples of transfers of value include payments for research and development, donations, sponsorships, consultancy fees, registration fees, and travel costs. Disclosures can be made on IPHA's website, which includes data from up to 50 companies, 11 of which are non-IPHA members. These disclosures are filed annually and are available for three years. However, this method of voluntary disclosure is only mandatory for IPHA members.

While the measures across the four areas I just outlined contribute to improved transparency, accountability and public disclosure, the Bill before the House gives us the opportunity to do more. The Government is supportive of the principles outlined in the Bill, and such measures would also be welcomed by key stakeholders, including patients. However, broader consideration than what this Bill currently provides for is needed. This Bill presents a potential opportunity to ensure that it is built on a national framework that achieves a balanced approach of enhanced transparency, ethical collaboration, accountability and public disclosure to maintain public trust in our healthcare system. The welcome development of a national framework should include analysis of: existing measures and their effectiveness; international best practice; minimising unintended consequences; proportionality of an enhanced framework for transparency, and structural engagement with key stakeholders. In particular, consideration of costs is required, particularly as the Bill envisages expanding the role of the HPRA to receive declarations from pharmaceutical companies, maintain a register of payments made by pharmaceutical companies and carry out audits and inspect the books of pharmaceutical companies. Any such granting of powers would require resources and additional capacity. Therefore, an appropriate funding model will need to be scoped, assessed and determined, including in the context of whether Exchequer funding is required.

These proposals contain wide-ranging powers and responsibilities. In addition to assessing the funding model, consideration of the parameters and safeguards of these powers will also need further consideration. This is to ensure a proportionate approach and to also acknowledge circumstances where commercial sensitivities may arise. In this context, the Minister for Health, Deputy Jennifer Carroll McNeill, has written to the Joint Committee on Health outlining these matters and her support for an exploration of them in further detail. The Department of Health will also give consideration to how well current measures are working and to what more could be done. It will consult further with the HPRA about the role proposed. Such due diligence is necessary in advance of implementing measures such as legislating for a register as set out in this Bill. As a result, the Government amendment seeks to allow time for the committee and the Department of Health to conduct their analysis and consideration before the Bill progresses. This is necessary as, given that a suite of measures is already in place to encourage transparency, a holistic consideration encompassing regulatory and legal considerations is required in advance of the introduction of any further measures. This is needed to ensure that any measures are proportional and achieve their goal of increased transparency with minimal or no unintended consequences. I welcome the debate and again thank the Deputy for raising this important matter.

See this speech in context