Wednesday, 16 May 2018
Medicinal Products Regulation
I welcome the Minister of State to the House and appreciate his taking the time to deal with this matter. As he is aware, I am a member of the Joint Committee on Health. We produced a report on orphan drugs, in particular trying to fast-track the process and bring more certainty at an earlier stage. I understand that the assessment process for many drugs here takes, on average, 23 months before a decision is made on moving forward to the next stage in the process. The people who are doing research and development in this area spend a lot of time and money trying to bring forward products which can be of benefit to people. Likewise, the number of people who would benefit from such drugs is quite small but it is very important to them. Over the past two or three years, a number of ongoing battles about whether a drug would receive approval have taken place in the public domain. The report sets out quite clear proposals about expediting and improving the process. The Minister of State should outline the work done by the Department and HSE to improve the processing of applications.
I thank Senator Colm Burke for raising this issues in the Seanad. Medicines play a vital role in improving the overall health of Irish patients. Securing access to new and innovative medicines in a timely manner is a key objective of the Irish health service. The challenge is to deliver on this objective in an affordable and sustainable way.
As of 11 May 2018, there are 120 orphan drugs in Europe. Of these, 12 have been refused by the European Medicines Agency, four have been withdrawn and 104 have had approvals. It is expected that the trend will be towards more applications for orphan drugs in the years ahead. That is why it is essential that Ireland has a scientific, robust and evidence-based assessment process in place. This ensures that decisions on the reimbursement of medicines are made on an objective and scientific basis, recognising the health needs of the population and other factors.
The Health (Pricing and Supply of Medical Goods) Act 2013 provides the legal framework in Ireland for such a process. This Act gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of expert opinion as appropriate. The HSE follows the process set out in the Act for the assessment of all drugs, including orphan drugs. While orphan drugs are assessed in the same way as other drugs, the HSE is mindful of the differences and challenges in terms of patient numbers.
The HSE strives to reach a decision in as timely a manner as possible and within 180 days. However, because of the significant moneys involved, the HSE must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. Successful price negotiations also allow for further drugs to be approved within the finite budget available.
A study published in December 2017 in the European Journal of Clinical Pharmacologyconcluded that the majority of European countries do not have a separate reimbursement system for orphan drugs. The Department of Health has received the report on evaluating orphan drugs from the Joint Committee on Health. The Department is examining the committee’s report and its recommendations. The report raises some significant policy issues which require careful consideration.
The Minister and the Department are very aware of the human side of this entire process. A medicinal products review committee has been established as part of the recommendations advocated by the national rare disease plan. This committee will look at the possibility of devising managed access programmes for patients, including orphan drugs, and will consider the need for different assessment criteria to apply in the case of drugs for rare diseases. The Government is committed in the programme for partnership to look at opportunities for leveraging purchasing power. That is why, over the past two years, my Department has been engaging with other European countries in an effort to identify solutions to medicines pricing, sustainability and supply.
Ireland is participating in several voluntary EU forums, including round-table meetings with EU health Ministers and the pharmaceutical industry, high level pharmaceutical policy meetings, the BeNeLuxA collaboration and the Valletta technical committee. These platforms are currently exploring possible areas for co-operation including information sharing, horizon scanning and possible price negotiations and joint procurement.
Ensuring timely and sustainable access to new medicines, especially orphan medicines, is a key priority of the Minister. The Department and the HSE are actively working towards this goal. However, any innovative approaches that may be tabled must be compatible with the statutory provisions which are in place and must also recognise the fundamental pricing issues in the context of finite Exchequer resources.
The European Medicines Agency approves drugs and we then seem to go through a process which takes over two years. That is causing a lot of frustration for people who could benefit if the drugs were available, as well as those carrying out research and development. That is why the report sets out clear recommendations. I ask that the Minister of State and the Department examine the report's recommendations and see which ones could be implemented at an early stage. They could then examine the other issues. It is important that we bring about some change in this area.
I thank the Senator and accept the challenge put forward by him. We have to ensure approval is timely, appropriate, represents value for money and that we are proactive as opposed to reactive. I will gladly take on board the request of the Senator to review the recommendations and see whether we can expedite any processes within the overall process.