Dáil debates

Thursday, 19 October 2017

Medical Practitioners (Amendment) Bill 2017: Second Stage [Private Members]

 

5:50 pm

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I move: "That the Bill be now read a Second Time."

I welcome the opportunity to present this Bill to the House and hope it receives broad support in terms of what we are trying to achieve. Its purpose is to make it a legislative requirement that there be a statutory declaration by consultants, clinicians and other medical practitioners who receive gifts or donations from pharmaceutical and other companies involved in the health care sector. These could include medical devices and other technologies. The purpose is to bring transparency. Medical practitioners may, at times, receive a gift or some other service from a company that might be providing medicines, therapies or technologies either to the clinician or broader health care sector. It is a meaningful and purposeful Bill. I am not alleging that there are diminished standards among the health care professions but I believe it appropriate for gifts worth over €600 to be declared statutorily and that they be registered with the Medical Council. That would bring transparency and openness to the system.

As we know, in the years ahead there will be major changes and advances in technologies and medicines, including fourth-generation medicines and orphan drugs. There will be a major increase in the State's requirement to fund these. Of course, with that comes a need to ensure full openness in how we assess and prescribe medicines across the health care sector.

There are some guidelines, including ethics guidelines, in play but they are all voluntary. If a clinician decides he or she does not wish his or her name to be published, it does not have to be. Pharmaceutical companies have a code of conduct but if the clinicians decide they do not want to have their name included, that is the way it is. That is not good enough. There needs to be full accountability and a proper register established whereby people who receive a gift or another service from a company would have to declare it on a statutory basis, as with Oireachtas Members and others.

When one looks at health care systems across the western world, significant increases in health spending are evident, in both the public and private health care sectors. The percentage of GDP spent on an annualised basis will increase substantially in the future. There are a number of reasons for this and they include advances in medicine, fourth generation medicines, orphan drugs, new technologies and medical devices and the fact that the population demographics in many countries in the western world indicate that there is an ageing population. With it comes greater costs and, accordingly, a greater requirement for the taxpayer to invest in and fund the health care service. At the very least, taxpayers should be entitled to know who is receiving a gift or a service from a company that may benefit from the State's investment in purchasing services from it.

Eminent consultants and clinicians who are internationally recognised and may be carrying out wonderful research work in a health care setting carry enormous weight in terms of their influence on the medicines that are prescribed, used and recommended across the western world. Their endorsement could have a significant impact on a company's profitability. For that reason, there is always an incentive to induce or encourage by means of supporting a person, either through soft supports, be they gifts or donations, or harder supports such as research funding. In some cases medical posts in this country are funded by pharmaceutical or medical device companies. I welcome the philanthropy, given that the State is at times financially stretched. The posts funded in full include physiotherapists, junior doctors and nurses in some hospitals and health care settings. There is nothing wrong with this in cases where it is a purely philanthropic endeavour by a company, but it does place people in a very invidious position, not only the individual whose salary is being paid by the company but also the health service in general because the staff are provided by the company. This issue needs to be addressed.

We must ensure there are clean lines of demarcation and that there is no overlapping or greying of the ethical barriers critical to health care provision. The Bill will act for the good of health care provision, openness and transparency and ensure medical practitioners will not be subject to suspicion about how they are funded. There were reports recently that the Health Service Executive had warned that it might stop buying medicines from pharmaceutical companies which do not name the individual doctors and health care organisations in receipt of multimillion euro payments from them. The HSE recently proposed including clauses in its contracts with pharma companies that would obligate them to identify all payments made. The head of the HSE's corporate pharmaceutical unit wrote to the Irish Pharmaceutical Healthcare Association, IPHA, expressing concern about hospitals and relevant agencies "claiming not to know about payments to health care organisations, HCOs, which then feeds into public discomfort or media controversy around the issue." There is concern among professionals who are dealing with the companies on behalf of the State and spending vast sums of taxpayers' money for the benefit of patients. He also warned that the refusal of "individual health care professionals, HCPs, to allow themselves to be identified" made it "easy for the media to point to a lack of transparency." It also makes it easier for me to bring forward this Bill and show that it is needed and deserves support.

The head of the HSE's corporate pharmaceutical unit also indicated that agreement was needed to ensure companies would no longer be able to make payments to health care professionals who refused to disclose moneys they had received. He outlined: "The HSE could obviously consider doing this unilaterally but my preference would be to agree the optimal solution and avoid any unnecessary conflict." If my Bill is put on a statutory basis and a register is established, compliance will be required and that will resolve all issues and remove potential conflicts of interest in the context of the State negotiating with pharmaceutical or medical device companies to purchase services and products from them for the benefit of the health service in general. It will ensure a very open and transparent system.

Late last year following an investigation by TheSunday Business Postit was claimed that drug companies were funding dozens of medical and nursing posts in some of the biggest hospitals in the country, while almost one third of the HSE's most senior doctors were receiving money from pharmaceutical firms. The investigation also found that hospitals were unable to account for millions of euro that pharmaceutical companies stated they had paid them. Hospitals stated they had no sight of many of these payments which were sometimes made to individual departments and organisations controlled by groups of doctors. TheSunday Business Post claimed that more than €17 million had been paid out in 2015. This figure excludes funding for research and development or clinical trials. Drug and health care organisations stated they could not disclose what some of the payments were for, citing "contractual obligations and associated confidentiality clauses". Some companies are also said to be paying millions of euro in fees to doctors to cover education, travel, speaking fees and payments to sit on advisory boards for pharma and medical device companies. This issue needs to be addressed. I hope that with support from all sides of the House the Bill can move through the legislative process and provide certainty. There is a significant pharmaceutical and medical devices industry in this country and it sits very easily and is compatible with the broad industrial policy of the country in attracting foreign direct investment, as well as major investment and incentives for research and development. The close symbiosis between universities and industry in general in research and development and scientific trials is all very welcome, but if it is to have international recognition, there must not be any suspicion of involvement in funding trials, clinicians or consultants. An air of suspicion is enough to cause concern in that regard.

The Bill will require some things to be done by the Minister, including, for example, the establishment of a register by the Medical Council, which is something we would like to see happen. As the Bill moves through the legislative process, I hope it will not be unduly delayed, given the large sums the taxpayer is spending on drugs, medical devices and other pharmaceutical products from companies located in Ireland and across the globe. I hope we will proceed in a timely fashion.

Drug firms are paying salaries in children's hospitals. Earlier this year the Irish Independentreported that drug companies were paying the wages of a significant number of staff in the country's children's hospitals. Our Lady's Children's Hospital, Crumlin which has been in the eye of the storm over waiting lists for scoliosis patients confirmed that pharmaceutical companies paid for a nurse and a health and social care worker who are doing wonderful work. I welcome the philanthropic approach of companies, but we must ensure no suspicions are raised about the companies in question.

A spokesman for Tallaght Hospital which incorporates the National Children's Hospital has also confirmed that there are three junior doctors and two nurses whose salaries are funded by drug companies. He has said they are involved in research and that some of the doctors also participate in the regular on-call rota. The companies are Merck, Pfizer and Sanofi. All of the staff are paid according to HSE pay scales. This shows an intertwining and an interdependence. For that reason, we must address the issue.

Children's University Hospital, Temple Street has indicated that three posts are funded by drug companies. They include a senior physiotherapist, a consultant and a research nurse at the national centre for inherited metabolic disorders. All the part-time posts are research-based, according to the spokesperson. The part-funding of the senior physiotherapist post is for assessment and input into treatment of children undergoing enzyme replacement therapy. It has contributed to research nationally and internationally. This is critical.

I am attributing nothing to any of the posts in the sense that there could be any conflicts of interest. However, what is most important is that no one else could. A statutory register would address all those issues. That is why I am presenting the Bill.

I am also presenting the Bill because clinicians approached me and asked me whether I would sponsor a Bill. They were concerned that the situation was undermining their professional integrity and the integrity of research and development. I am seeking clear stated lines of demarcation, barriers that cannot be greyed or frayed away at the edges. We need full confidence in our clinicians, in prescribing and in research and development. That is why I brought the Bill to the House. I was asked by eminent principled consultants to do so. These medical practitioners expressed concern that this could undermine the integrity of the profession if it were allowed to continue and evolve over the years.

Another issue that will have to be addressed is the way we fund all these drugs, including orphan drugs, fourth generation drugs and other high-tech advances in years to come. That is for another day but it has to be done soon. Otherwise we will have a situation whereby we will continue to have patient advocacy groups lobbying - begging, effectively - for the State to fund drugs that could have a major impact on their lives. We have to discuss those issues with the National Centre for Pharmacoeconomics as well as how we assess and fund drugs now and in future. That is for another day but it has to happen quickly. In the meantime, I commend the Bill to the House.

6:10 pm

Photo of Bernard DurkanBernard Durkan (Kildare North, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Now I am in a quandary. The Minister of State has a speech, so she is next to contribute. That is the running order.

Photo of Catherine ByrneCatherine Byrne (Dublin South Central, Fine Gael)
Link to this: Individually | In context | 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.

6:20 pm

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I thank the Minister of State.

Photo of Bernard DurkanBernard Durkan (Kildare North, Fine Gael)
Link to this: Individually | In context | Oireachtas source

The Minister of State may be in need of some pharmaceutical assistance. I call Deputy Louise O'Reilly.

Photo of Louise O'ReillyLouise O'Reilly (Dublin Fingal, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

I commend Deputy Kelleher on this Bill. I am glad to say that Sinn Féin will support it. I have not been in this line of work for long but I am learning that a short Bill can do more than a very lengthy Bill. This is the case with this legislation. It is a good and fair idea that medical practitioners declare any income or gift received from medical suppliers, pharmaceutical companies or any other source. I think Deputy Kelleher was very clear that this is not, and I do not believe, that this is meant to punish practitioners. It seeks to ensure transparency for gifts or bursaries provided to medical practitioners in order that the Medical Council and public can be aware of a situation which may arise wherein certain medical suppliers or pharmaceutical companies are overly generous, for some reason, if we can use that term. Any measure which improves transparency can only be considered progressive, especially when it comes to transparency regarding gifts, moneys etc.

Given the sensitive nature of health care, we must ensure that it is open and transparent at all times and that there is no perception of conflicts of interest. It is particularly important for the public and other medical practitioners to know that no conflicts of interest are at play. In March, Deputy Kelleher said that he tabled this Bill because some eminent clinicians had come to him and expressed concern that the issue of pharmaceutical companies interacting with clinicians and supporting them in a meaningful way is becoming more pervasive not only in this country but across the western world. I agree with Deputy Kelleher, and since this Bill passed First Stage, a number of clinicians have raised concerns about the granting of gifts as a possible problem with regard to medical suppliers and pharmaceutical companies. There need to be clear lines of demarcation and no overlapping or greying of ethical barriers critical to health care. The fact that this is being supported and driven by medical practitioners themselves is worth noting. Health care must be administered in an ethical manner where there is trust between both parties.

Both Sinn Féin and I support this Bill and its aims. However, we will seek clarity in areas on Committee Stage and we may seek to make some amendments, although the intention would be to improve the Bill where we can in a spirit of collaboration. A problem I have is that the amount specified is €600, but it may be the case that an individual receives multiple gifts, bursaries or whatever the term might be, each to the value of €599. We could have a problem in that regard, but I am not convinced that it is one we cannot overcome. I think it would be easy enough for us to get over that. There may be a need for some amendments, which we will table. The legislation may defeat its own purpose if gifts in excess of €600 in one year could be given as long as no single gift exceeded €600 by itself. We can keep an eye on that and, given that we all intend to work together to ensure that this can be done, I do not think that any of those problems are insurmountable. We will table amendments and work together as is appropriate.

I hope that something can be done for medical practitioners who have to attend countless conferences and purchase numerous different pieces of equipment from year to year to ensure that they do not suffer, are able to upskill and have access to the most modern equipment.

However well intentioned the pharmaceutical companies are, and nobody is ascribing anything other than an altruistic motive them, it is not acceptable that they would be funding posts within the health service or, indeed, that they fund doctors, nurses and medical practitioners to avail of important conferences that they need as part of continuing professional development, CPD. There is a role for the State in that regard and we should be supporting our clinicians and medical practitioners more.

I go back to the earlier point that this is being driven by clinicians and they would not be raising this issue in order to effectively hamper themselves. Clearly, they need access to CPD and to conferences. They need access to interaction with their peers, which is extremely important. If that is being facilitated by outside sources we need to look at how best we can support medical practitioners outside of the help that they get from pharmaceutical companies. The State will have to step up to the plate in this regard.

Overall this is a good Bill and we in Sinn Féin are happy to support it.

6:30 pm

Photo of John BrassilJohn Brassil (Kerry, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I welcome this Bill from my colleague, Deputy Kelleher. I also welcome the positive response from the Minister and from Deputy Louise O'Reilly on behalf of Sinn Féin. With collaboration, we can get this legislation passed. It is meaningful in that it seeks to clear up the relationship between drug companies and medical practitioners to ensure that there are no beneficial rewards going to drug companies from clinicians.

Clinicians themselves would greatly welcome this. Statutory declarations are nothing new. We have been subject to them for many years. It has very much helped clear up the understanding that politicians in receipt of donations declare them and get on with their work without being beholden to anybody. The medical profession would welcome this clarity as well, particularly when a person such as Profession Michael Barry expresses concerns. Professor Barry believes that it influences prescribing patterns at present and he also has great difficulty where clinical leads are in receipt of any payments. I do not have any issue with drug companies making philanthropic donations to fund doctors or nurses, or whatever they want to fund, as long as it is upfront, declared and is for a hospital body as opposed to a specific clinicians who may have influence on prescribing patterns.

While I have the opportunity and while the Minister, Deputy Harris, is in the House, I would like to raise the issue of biosimilar projects, which I mentioned last week in the Minister's absence. I was under the impression that we needed a legislative change but the Minister has written to me since to clarify that there is no need for it. However, I would draw the Minister's attention to two products that are available at present. Enbrel is used for arthritis. There are 14,000 boxes a month being prescribed. It is a useful and effective drug. In recent times, there have been two biosimilars. One, Benepali, is available in this country. There are 56 boxes of that prescribed a month, versus 14,000 Enbrel. The different in cost at present is approximately €120. Multiple €120 by 14,000 by 12 and one will get the figure of a potential saving in the system. This morning I met the PKU Foundation trying to approve the use of the drug KUVAN and the cost is infinitesimal compared to that. We are looking for savings. We are looking for money to fund new endorphin drugs and maybe the solution is before us if we investigate it thoroughly. As the Minister will be aware, I am a practising pharmacist. A similar process happened with generic products many years ago. It was resisted repeatedly and now generic products are part and parcel of prescribing and pharmacy. They have brought about significant savings and that is as it should be. The companies that said they would go out of business have not done so and they are competing and maintaining their market share. That is something that we should be mindful of.

In working to pass this Bill, transparency, good prescribing practices and good value for money should be to the fore. It is the taxpayer who is paying for it. It is the HSE, using taxpayers' money, that is paying these bills and therefore they should be fully transparent and open to scrutiny. Everybody would be happy with a situation where there was a guarantee that this was happening.

I accept that there are issues with the Bill as drafted that need to be amended and my party will work with the Minister along with the other parties to ensure this happens. I commend this Bill, along with my colleague, Deputy Kelleher, to the House. I look forward to a speedy resolution and getting the Bill into Committee Stage and getting it passed.

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I thank Deputy Kelleher for bringing forward this important legislative proposal. I commend the Deputy on his work in this area and assure him that I and Government will support the reading of this Bill for a Second Time. In doing so, I caution that, as has already been recognised by Deputy Kelleher, we need to do a good bit of work to tease through the Bill before it proceeds to the next Stage. I note the Deputy is open to having a kind of pre-legislative scrutiny stage at the Committee on Health where, I think, we can work through the detail. That would be important.

The Government fully subscribes to the objectives behind the Deputy's Bill, which are primarily to protect the public. I am committed to working with Deputy Kelleher, Deputy Brassil and Members of this House to come up with more workable solutions to achieve full transparency in funding and supports provided by either medical device suppliers or pharmaceutical companies to healthcare providers and healthcare organisations. That phrase "full transparency" is appropriate. Nobody here is trying to shut down a source of funding or support. It is about ensuring that any funding or support received is fully transparent. Deputy Brassil correctly stated that those of us in this House are rightly subjected to that level of transparency. Many in public office and positions of public influence are rightly subjected to a degree of transparency. It is important that such transparency which, as Deputy Louise O'Reilly correctly stated, is so often wanted by clinicians, is clearly put in place in a consistent manner.

As I am obliged to do, I will outline some of the areas that we need to clarify as we further scrutinise the Bill. We need to look at the Bill being clearer in its definitions so that we have a definite idea of its scope. For example, does "medical equipment" mean "medical devices" or is it broader? As the Bill is currently drafted, its scope relates to medical practitioners only. However, we know that dentists and some nurses also prescribe medicines and that pharmacists play a key role in the delivery of healthcare. We can have that debate and tease out those issues. The inclusion of other professional regulators will be required for this purpose and the logistics and costs of that will have to be assessed. Furthermore, healthcare organisations also receive funding and support from industry and in order to be comprehensive and equitable, the Bill should also deal with these recipients. Therefore, while I support the general thrust of the Bill because I agree with its overall objectives, I believe there is potential to broaden its scope to achieve full transparency.

We must aim for full transparency on all transactions between industry and healthcare providers in order to assure the public that the relationship between the respective parties does not influence the clinical judgment or clinical decisions. The public must have full confidence that healthcare providers prescribe treatment or administer appropriate care based solely on the clinical evidence before them and that they do so also with patient safety and the health and welfare of patients as the overall motivation. I have no doubt that is the overall motivation for the overwhelming majority of those working in the health service.

The Medical Council and other professional regulators are already working to protect the public. In addition to complaints and fitness to practice their role has already expanded in terms of the development of professional competence schemes and providing assistance to individual medical practitioners to ensure that their practice meets the highest standards. Enforcement of this current proposed legislation will add a further challenging workload to the council, when there may be an alternative route to achieve the same end-point through other legislation.

Legislative scrutiny, as I have said, needs to take place on the Bill to investigate what is the best form of legislation to achieve our overall shared objectives. While the OECD reported that most countries rely significantly on self-regulation to prevent inappropriate business practices between the industry and providers, there are some examples of countries, such as the USA and France, where legislation has been successfully enacted to address these issues.

Other countries have done this already and it is for that reason that I support Deputy Kelleher's Bill. However, I have cautioned that we need to collectively examine it carefully, to explore how best the legislation can be framed to achieve the ultimate aim of full transparency in relation to the transactions between industry and the providers of care. We owe it to the public to develop robust legislation. The efforts of the Irish Pharmaceutical Healthcare Association in relation to voluntary disclosure of transfer value should be acknowledged but this has only been partially achieved due to data protection impediments. Legislation in other jurisdictions should also be examined in order to ensure that we achieve the absolute optimum outcome.

I sincerely thank Deputy Kelleher for bringing forward this Bill which moves on this process. We have been talking in this House about doing something in this area for a long time and Deputy Kelleher's Bill is an honest and decent attempt to do so. I look forward to it being scrutinised by the Oireachtas Committee on Health and then seeing this legislation progress through both Houses. I hope we can work in the spirit of co-operation and collaboration to bring about the best legislation and to arrive at a point where we can inject full transparency into this area, which is what we all want.

6:40 pm

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I thank the Minister for making the effort to be here this evening and for his contribution. I also thank the Minister of State, Deputy Catherine Byrne, Deputy Louise O'Reilly from Sinn Féin and my party colleague, Deputy John Brassil, for their contributions to this discussion.

It is important to point out that when we bring forward legislation, we do so in the interests of the public good. This debate has focused on the issue of how clinicians, medical practitioners and prescribers interact with the broader industry. There is absolutely nothing wrong with that. It is a good and healthy situation that we have a critical mass of pharmaceutical and medical devices companies in this country which interact with universities, colleges and hospitals in the context of research and development. That has brought about a transformation in both medical technologies and medicines. If one takes the research conducted across the globe in recent years into cancer, we can now treat some cancers that were untreatable only a few years ago. The same is true of treatments for HIV, hepatitis and so forth. Profound changes have been brought about by pharmaceutical companies interacting with colleges and research institutes across the globe. Such interactions have resulted in the development of transformative medicines that can change and save lives. It is a positive thing and all we are asking for is transparency to ensure that nobody could have suspicions or undermine the credibility of the research and innovation that is taking place across the globe. Obviously, in the Irish context, we can only address it legislatively here.

This Bill was prompted by clinicians who approached me, asked me to raise this particular issue, sponsor legislation and bring it to the floor of the Dáil. They wanted to get the debate going and I thank the Minister for his contribution to that debate. If we could shepherd this Bill through the legislative process by commencing the pre-legislative scrutiny process and using the resources and knowledge within the Department as well as in the Attorney General's office to improve the Bill, I would be delighted and will be happy to assist in any way.

As I said earlier, philanthropy is a good thing. Just because a company is sponsoring a nurse or doctor does not mean that there is anything untoward happening. However, it should be up-front and declared. To move away from the legislation slightly, I wish to refer to the advances that have been made in medical technologies and medicines and the great challenges facing the State in the coming years in terms of funding those medicines. In that context, we will have to broaden our discussion of how we assess and fund new medicines and medical technologies. While the National Centre for Pharmacoeconomics, NCP, under Dr. Barry does its job, we need to look at the assessment of drugs for rare diseases. Other countries seem to use a different system of assessment and funding and there is a European dimension to this that we must begin to embrace. I know that the Minister is examining that concept but we must be more proactive in how we embrace advanced, innovative medicines and in terms of how we assess and reimburse them. That is an area where we are beginning to drift. That is not a criticism but an observation.

I know the State has limited resources. Decisions on reimbursement are made by the NCP which has its own guidelines. Reference must also be made to the HSE's corporate pharmaceuticals unit which enters into negotiations with pharmaceutical companies and may or may not reimburse. Then we have advocacy groups who literally have to come to the gates of this Dáil to try to prise the system open to allow certain drugs to be reimbursed. We have to be more open in how we conduct that assessment process. We need meaningful assessments that can be viewed in an open way. I will always accept that there are commercial sensitivities involved but it seems that other countries can do this in a more meaningful way that allows them to deliver drugs to patients in a more timely manner. If countries which have a smaller GDPper capitathan ours can fund these drugs, why can we not do so? We are cutting edge in many areas but in recent years we have slipped back to a certain extent in embracing new, modern, innovative technologies and drugs. It is an issue for another day but it relates to this legislation. We need to have openness and transparency in the context of clinicians, prescribers and those who are recommending medicines in our health system. Equally, we must have openness on the other side in terms of how we assess and determine what drugs are reimbursed and made available in the health system.

I thank the Minister for his remarks on the Bill. I have already referred to the reasons for bringing the legislation forward, some of which would certainly cause concern. As I said, however, I do not want to suggest that any clinician has engaged in untoward activity. I simply want to bring openness to the area and some of the professional bodies have also recommended that something be done on this issue. If the Minister could help us to move this Bill through the legislative process, that would be a good day's work not only for the State and the public purse, but also for the integrity and credibility of our clinicians, the research they undertake, the clinical trials in which they are involved and the prescribing patterns in our health service.

Question put and agreed to.