Catherine Byrne (Dublin South Central, Fine Gael) | Oireachtas source

The Minister for Health will be here shortly. On behalf of the Minister, I wish to thank Deputy Kelleher for introducing this important legislative proposal. The Minister supports the reading of the Bill for a Second Time. He agrees with the overall objective of the Bill, which is to provide transparency regarding any funding or supports to medical practitioners by either medical device suppliers or pharmaceutical companies. Such transparency is ultimately aimed at protecting the public.

My Department has examined the Bill, as drafted, and on the basis of this examination the Minister has some concerns. He believes it needs considerable rewording to fully achieve our shared objectives. Primarily, he believes that the provisions should not only apply to medical practitioners but to other health care professionals, including nurses, pharmacists, dentists and other health and social care professionals. He believes they should also apply to health care organisations, especially hospitals. We wish to develop the optimum legislative solution to achieve our shared objectives. The Minister and the Department will work with Deputy Kelleher to achieve the best result for the public, one that provides transparency on the transactions between medical device suppliers or pharmaceutical companies with all health care providers.

The ongoing collaboration between industry and health care providers through research and clinical trials has delivered numerous innovative medicines and has changed the way diseases impact on patients and their lives. This has been achieved through the continued sponsoring of research and clinical trials by the industry and through supporting the development and understanding of new treatments for the management of diseases. Government does not want to negatively impact on such partnerships. Rather, the main objective of the legislation is to ensure that there is full transparency on transactions, in turn ensuring that industry and health care providers adhere to the highest standards of ethics, with the public interest and patient safety being central at all times.

The OECD in report from January this year, Tackling Wasteful Spending on Health, noted that more transparency in the financial relationships between industries and health care providers is increasingly promoted by self-regulation. Initiatives include the European Federation of Pharmaceutical Industries and Associations code of conduct, to which the Irish Pharmaceutical Healthcare Association subscribes. Some countries have introduced so-called sunshine-type regulations, which require that payments by industries to stakeholders be systematically reported to authorities. In the United States, for example, industries must report relationships between pharmacists, physicians and teaching hospitals. In France, disclosure under similar legislation, covers ties with all health professionals and associations representing them, scientific societies, patients' associations and the press. The broader approach which addresses industry supports to all health care professionals and health care organisations could be the ideal solution for Ireland as well.

The European Federation of Pharmaceutical Industries and Associations requires disclosure by its member companies for prescription pharmaceuticals. As a member of the federation, the Irish Pharmaceutical Healthcare Association, which represents 44 international research-based companies, has adopted a transfers-of-value voluntary pharmaceutical code. Since 1 January 2016 the code obliges members to make publicly available information relating to donations, grants and sponsorships to health care organisations and health care professionals. The association provided €30 million to Irish health care organisations and health care professionals in 2016. However, health care professionals may refuse to allow disclosure of their details under the code pursuant to data protection legislation. In such circumstances, pharmaceutical companies disclose only aggregate data, but this does not provide transparency. Each company is, however, required to indicate the number of health care professionals included in the aggregate disclosure. Given that data on financial and other supports to all health care professionals and health care organisations is in the possession of the pharmaceutical companies and medical device suppliers that provide the supports, it would be useful to investigate whether it would be possible for data protection problems to be overcome in the interests of the integrity of the industry, the public good and patient safety. It is important that industry transactions with providers of health care meet the highest standard of integrity that patients, governments, regulatory bodies and other stakeholders expect. We must assure the public that such relationships do not influence clinical decisions and that patients can trust their health care provider to recommend treatment or administer appropriate care, based solely on clinical evidence and experience and in the best interests of the patient and patient safety.

The advertising of medicinal products is already governed by a combination of legislation and self-regulatory codes of practice. The principal regulations are the Medicinal Products (Control of Advertising) Regulations 2007, which implement parts of the European Pharmaceutical Directive 2001/83/EC. The Health Products Regulatory Authority is responsible for monitoring the advertising of medicinal products and enforcing these regulations. The authority is increasingly active in pursuing cases arising out of breaches of the advertising regulations. Increasingly, the authority monitors advertising practices through social media. In addition, the general laws concerning advertising and commercial practices are set out in the Consumer Protection Act 2007 and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007.

We must ensure that all proposed new legislation works in harmony with existing legislative provisions. Under pharmaceutical legislation it is prohibited to supply, offer or promise gifts, advantages or benefits-in-kind to health care professionals in the course of promoting medicinal products. Health care professionals are also prohibited from accepting such items. The prohibition does not apply to the transmission of information or educational materials or to items of medical utility, which will be permitted in certain circumstances.

A pharmaceutical company may provide support in the form of educational, research or employment grants and donations or sponsorship of medical equipment for the betterment of patients. The provision of such support must not be conditional on the prescription, supply or use of the company's products or be linked in any way to promotion. The support must be modest, reasonable and in proportion to the scale and scope of the institution receiving it. Given that strong legislation is already in place, we need to consider carefully whether enhancing pharmaceutical and medical device legislation may be a better approach to achieving our shared objectives.

The HSE does not centrally hold information on transfers of value. However, under its code of standards and behaviour, the consultant contract and the ethics Acts are the bases under which individuals must refrain from any activity which causes a conflict of interest. It has noted, however, that it would welcome full transparency on transfers of value.

The Medical Council's Guide to Professional Conduct and Ethics sets out the standards for the conduct for doctors regarding gifts or payment by pharmaceutical companies. The guide states that if doctors are paid directly or indirectly by pharmaceutical, medical device or other commercial companies or organisations to conduct medical research, they must make sure that the payment does not influence their study design or interpretation of research data. They must also address any potential conflict of interest and disclose the payment in any publication of research results. It also states that doctors should not accept gifts, including hospitality, from pharmaceutical, medical device or other commercial enterprises. This does not prevent doctors from attending educational meetings or receiving payment of reasonable fees for professional services to commercial enterprises. If they are involved in any way in promoting or endorsing specific health care products or services, they must declare any financial or commercial interest they have in the organisation or company providing the products or services. It is important that any legislation is aligned with current oversight by the Medical Council. For this reason, the definition of gift and the value given in the proposed Bill of anything in excess of €600 should be especially scrutinised.

We must ensure that this proposal does not place an unnecessary administrative burden on the Medical Council or indeed on other professional regulators if it is decided that the legislation should be extended to other health professionals making annual declarations. The Medical Council has a challenging role in regulating almost 21,800 medical practitioners and in promoting good professional practice among doctors in the interest of public health. It also deals with complaints which may be escalated to its fitness to practise committee, which may result in medical practitioners being removed from the register. It currently has difficulties managing the volume of complaints received. The council must enhance its role in relation to professional competence of doctors and it must also, with the enactment of the Medical Practitioners (Amendment) Act 2017, check that all medical practitioners, on application, are placed on the council's register and have minimum levels of indemnity cover on annual renewal of registration.

There are no costs to the Exchequer in the proposal. However, additional resources will be required by the Medical Council to administer these new functions. Since the council is self-funding, it will have to generate any costs required to implement this proposal from the fees paid by registrants. It may need to increase fees, therefore, subject to ministerial approval, to introduce a system that collects and processes the information received. Some of the other regulators which are not self-funding would require Exchequer funding to implement the proposals.

The definitions and terminology in the Bill will need considerable amendment to avoid misinterpretation and to be consistent with current definitions in legislation. For example, we are unsure whether the term "medical equipment" is meant to cover medical devices only, which are already clearly defined in existing legislation, or if it is meant to cover something broader than medical devices.

The Minister, Deputy Simon Harris, has just arrived. While he is supporting the Bill being read a Second Time, he is also pointing to the significant work that needs to be undertaken before the Bill proceeds further. We should first explore whether the data protection provisions currently preventing pharmaceutical companies from publishing data on transfers of value can be overcome in the interest of the public good. If not, a similar problem may arise for regulators with this current legislative proposal. We also need to check whether pharmaceutical and medical device legislation would provide a better route to achieving our objectives. We are committed to working with Deputy Kelleher on this important proposal to curb ethical violations in the health sector and to contribute to patient safety. We look forward to keeping the House informed of developments in addressing our shared objectives.

I apologise for my husky voice.

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