Ms Mary Jackson:

I am a principal officer in the governance and clinical indemnity unit in the Department of Health. Mr. Eugene Lennon is principal officer in the medicines and controlled drugs unit. I thank the committee for the opportunity to provide the Department of Health’s observations on the Medical Practitioners (Amendment) Bill 2017 at this scrutiny stage of the Bill.

By way of background, as we heard from Deputy Kelleher, this Private Members' Bill was published in March 2017. The Bill would require medical practitioners to declare any income or gift received from medical suppliers or pharmaceutical companies which exceeds €600 in value to the Medical Council in a statutory declaration annually. It was introduced on Second Stage on 19 October 2017.

The Minister for Health, Deputy Simon Harris, strongly agrees with the general principles behind this Bill. There should be transparency about transactions between commercial interests and health care providers so that the public can be assured that health care providers recommend treatment or administer appropriate care based solely on clinical evidence and experience and in the best interests of their patients and patient safety.

The tabling of this proposed legislation is timely. There have been a number of similar developments across Europe in this important area since 2010, when the Physician Payments Sunshine Act was first introduced in the United States. Under that legislation, the pharmaceutical industry must report relationships with doctors and teaching hospitals to the government-run programmes Medicaid and Medicare. In France, disclosure under similar legislation covers relationships with all health professionals and associations representing them, scientific societies, patients’ associations and the press. In the Netherlands, a Healthcare Transparency Register was introduced in 2013 to disclose payments and gifts to health professionals from pharmaceutical companies. This publicly accessible register was extended in 2016 to cover medical devices also.

In examining reports on the laws, regulations and codes across Europe, we observe that the self-regulatory code on transfers of value from pharmaceutical companies to Healthcare Professionals and Healthcare Organisations of the European Federation of Pharmaceutical Industries and Associations, EFPIA, is common to all countries. As we have heard already, however, one of the shortcomings of this code is that health care professionals may choose not to allow their individual details be published. This means that there is not full transparency, as only the composite totals of payments to those individuals is then published. Furthermore EFPIA and its member associations represent only part of the pharmaceutical industry.

In Ireland the Irish Pharmaceutical Healthcare Association, IPHA, applies this code to 44 of its members. In 2016, €30 million was provided to Irish health care organisations and health care professionals by EFPIA. Of this sum, however, just over €7 million went to health care professionals, while €10 million was directed to health care organisations. The balance of €12.6 million was directed to clinical trials and research and development. In addition, because of the voluntary nature of the code, we understand that only around half of health care professionals in Ireland permit their information to be published.

We thus have problems with transparency. Other countries have experienced the same problems, with some health professionals choosing not to register transfers of value. To address this, some countries, such as the UK, have introduced anti-corruption laws. Interestingly, Scotland is considering the introduction of Sunshine-type regulation, and the Scottish Parliament has debated it quite recently. There are also so-called "Sunshine laws", or regulations similar to those enacted in the US, in The Netherlands, Belgium, Denmark and Portugal.

The current proposal is straightforward, requiring doctors to make a declaration to the Medical Council every year on funding and supports received from commercial interests. The definitions and terminology in the Bill require amendment to become consistent with existing Irish and European pharmaceutical and medical device legislation.

We also believe the scope of the Bill may be too narrow to achieve the overall objective of transparency, as it limits transparency to doctors only, while other health professionals and health care organisations are also involved. If we are to consider broadening the scope, we should also look at where the register should be located and maintained.

Another relevant question is whether the register should be populated by the recipients of transfers of value or by those providing them. We question whether it would not be better to set up a register in an alternative location to the Medical Council in order that there would be the potential to cover transfers of value to other health professionals and health care organisations.

I will now make some specific comments on the Bill. In section 1, the definition of "declarable income" as "money or other form of payment" is too narrow. A transfer of value can be monetary, such as a fee for service or loan for the purchase of a device, but it can also be a non-monetary benefit, such as a flight, a registration fee or hotel accommodation. The reference to the term "gift" needs to be checked to ensure that it does not conflict with advertising regulations which allow for free samples to be provided in certain circumstances.

The terms "medical equipment" and "supplier" are not recognised terms under EU or Irish legislation. The term "medical device", which is used in existing legislation, includes medical equipment. On the term "supplier", EU legislation on medical devices defines a "manufacturer" as a "natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished and markets that device under its name or trade mark". EU legislation also defines a "distributor" and "authorised representative", but there is no definition of "supplier". We must be very careful around the consistency of definitions in the legislation.

There is no definition of "pharmaceutical company" in EU medicines legislation. EU legislation refers to "marketing authorisation", which means approval to market a medicine, and there is a lengthy definition of a marketing authorisation. Companies are known as "marketing authorisation holders", where the company or other legal entity is granted approval to market a medicine in one, several or all EU member states.

We suggest that a value of above €600 may be too high. This figure is set at a total of €500 per annum in the Netherlands. Similar legislation in other jurisdictions sets much lower threshold values, in some cases as low as €25. In addition, as the legislation is currently worded, it does not pick up on multiple payments to a medical practitioner of less than €600 which together would breach the threshold. For example, a doctor could receive two or more payments of €400 each without breaching the legislation.

The Bill refers to the Statutory Declarations Act 1938 as the means by which doctors would declare the gifts and supports received. We may need to look at this because a statutory declaration under that legislation involves a person making a statutory declaration in front of either a notary, a commissioner for oaths or a peace commissioner.

Section 2 of the Bill proposes amending section 8 of the Medical Practitioners Act 2007 to mandate that doctors would make an annual declaration to the Medical Council of any declarable income or gifts, which would be placed on a publicly accessible register. Failure to do so would result in a complaint being made to the council. The onus of collecting annual declarations from doctors of their supports or gifts from commercial interests and placing this information on a publicly accessible register would create a new function for the council. Currently the council does not deal with pharmaceutical or medical device legislation, so if it is to maintain and respond appropriately to declarations received, it will have to build competence in this area. It already has a very challenging role in regulating around 21,800 medical practitioners and in promoting good professional practice in the interest of public safety. It also deals with complaints, which may be escalated to its fitness to practise committee. These may in turn result in a medical practitioner being removed from the register. Since the commencement of the Medical Practitioners (Amendment) Act 2017, on 6 November last, the council must also check that all medical practitioners, on applying to be placed on the council’s register and on annual renewal of registration, have minimum levels of clinical indemnity cover. While Deputy Kelleher has said this change is a simple process within the Medical Council, maintaining this register will be another function on top of what is quite a challenging role for it in supervising the clinical competence and the clinical oversight of doctors.

The proposed Bill puts the burden on doctors to report. Approaches in other jurisdictions require pharmaceutical and medical device companies to report on their affiliations and financial relationships. Recognising that the objective of this Bill can be met by different approaches, we believe more time should be taken to consider these options, fully examining the benefits and drawbacks of each to adopt legislation which is robust, fair and achieves the objective of transparency for the public. We do not want circumvention of any legislation that we put in place. The options for changing the scope depend on whether it should be the payer or the receivers of transfers of value who populate the register.

We have identified five potential options, and there are probably more. The current option of making the Medical Council the holder of the register is one. Option 2 would be for it still to apply only to doctors but for a register to be established elsewhere and have commercial interests populate the information on the doctors to whom they provide transfers of value. Another option would be to extend the scope of the Bill to all health care professionals, including nurses, pharmacists, dentists and allied health professionals. As we have heard already, there are definitely transfers of value to nurses but, I think, to all of the others as well. Option 4 would be to extend the scope of Bill to cover all health care professionals and health care organisations in the public system. We have heard again this morning that the transfers of value may be to hospitals and other facilities. Extending the scope to that would cover those transactions. Another option would be to extend the scope to cover all health care professionals and health care providers in both the public and private health care systems.

A major consideration is where the register of transfers of value should be located and maintained. We pose the following questions. Should the register relate to doctors only and be the responsibility of the Medical Council, as per the current legislation? Should it be established where all health professionals can be registered, as it would not make sense that each regulator would set up a separate register? Should there be a national register which includes transfers of value to health care organisations as well as health care professionals? Should the Health Information and Quality Authority, HIQA, which oversees standards within the health care system, hold the register, or should it be the Health Products Regulatory Authority, HPRA, which already has responsibility for regulation of pharmaceuticals and medical devices? Should the register be located in the HSE, if it is only publicly funded agencies that are covered, or the Department of Health, or indeed an independent entity external to all of those I have listed?

The cost of setting up and maintaining the register could be significant, so a costing model is needed to assess the respective costs of the options proposed and to find the optimum solution. The legislation may be too ambitious in including medical devices at the very outset. It may be prudent to commence with pharmaceuticals only, test the workability of the system and then extend the scope as soon as possible thereafter to medical devices, because of the different regulatory regime applying to both areas. This stepwise approach worked well in the Netherlands.

I hope the Department’s comments are helpful and constructive. The Bill gives the opportunity to address a gap in legislation, which we all want to see happen and which many other European states are in the process of addressing. With robust legislative scrutiny and consultation, the resultant legislation will be based on the best models in place in other jurisdictions and what would work best for Ireland. The committee may wish to consider inviting other witnesses such as the HSE, the Pharmaceutical Society of Ireland and other regulators to advise on the best fit for this legislation.

The obstacles to effective regulation of this area must be overcome through consultation and collaboration with the relevant parties, who wish to see full transparency in the interest of best patient care. I would like to reaffirm that the Minister and the Department strongly agree with the principles underpinning this Bill. We are committed to working with Deputy Kelleher and his legislative advisers on this important proposal.

I thank the Chair. My colleague and I will be happy to answer any follow-up questions.