Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018
Considered in Grand Committee
My Lords, today we are debating two regulations which are part of a wider set of European Union directives that set quality and safety standards for human tissues and cells that are used in patient treatment.
It is vital that UK patients should have every opportunity to access the kind of life-changing therapies covered by these regulations, such as stem cells used to treat blood cancers, corneas to restore sight, heart valves to treat heart conditions or skin grafts to treat burns. As noble Lords are probably aware, these tissues and cells may be donated in the UK or anywhere in the world and of course we need to know that they are safe to use.
I will touch on the history of the European tissues and cells directives. As the world leader in tissue banking, the UK welcomed the proposals to introduce a European tissue and cells directive. The Government supported the directive because it meant the voluntary accreditation scheme for tissue banks in operation at that time was placed on a statutory basis. The first directive included provision to make four Commission directives setting out the detail of the procedures needed to meet the prescribed standards. The coding and import directives are the final two of these Commission directives which we are discussing today.
Traceability of tissue and cells from the donor to final use in a patient’s treatment is important for identification purposes. If a patient suffers a serious adverse reaction, donors and other recipients can be traced quickly to minimise the risk of further harm. Tissue and cells now regularly move across borders, making the need for an international, recognisable identification code. This is essential to mitigate future patient safety risk. While UK legislation largely achieves the aims of the coding and import directives, it does not meet all the specific requirements. These regulations transpose the provisions in the coding and import directives, making us consistent with the EU. With exit negotiations ongoing, our priorities are to maintain the high standards for safety and quality after our exit from the EU and to find a way to continue to share tissues with EU countries.
One possible outcome of the negotiations is that the UK decides to maintain equivalence with the EU provisions in this area. In that situation, we need to demonstrate that the coding and import directives have been implemented. Because of pre-existing UK legislation, we have drawn up two sets of regulations, the Human Fertilisation and Embryology (Amendment) Regulations 2018, for reproductive cells, and the Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 for all other human tissues and cells. Both regulations will come into force on 1 April 2018. That is what leads us here today.
Let me explain the two directives. First, the coding directive establishes the single European code, designed to provide important basic information on the origin, properties and use-by date for the tissue of cells. As I mentioned, the primary purpose of the code is to enable material to be traced throughout its journey from the donor to final use in treatment of the recipient patient. Effective traceability is vital to investigating any serious adverse reaction to the tissue suffered by the recipient, or any serious adverse event that may have compromised its quality or safety.
Secondly, the import directive ensures that tissues and cells imported from countries around the world meet equivalent quality and safety standards to that of tissue procured within the EU. It also determines what documentation must be provided to the importing country’s competent authorities to enable them to be satisfied as to the quality and safety of the imported tissues and cells.
Ahead of where we are now, a range of consultation activities have taken place to consider how these provisions would work in the UK. The Department of Health and Social Care set up an advisory group which included representatives of professional bodies, tissue banks and service providers. The competent authorities consulted their licensed establishments and a public consultation exercise ran from 10 March to 7 April 2017, receiving 15 responses. While there are gains for the UK in transposing the directives, there will be a cost to licensed establishments, including those in the NHS, in implementing these regulations. Importantly, the regulations have been drafted to ensure that no unnecessary administrative burdens or costs are placed on the UK’s licensed establishments. They simply transpose the directives while avoiding any add-ons.
These regulations fulfil a UK obligation as a current member of the EU. Importantly, they bring into UK law provisions to enhance our existing robust controls that ensure donated human tissue and cells used in the treatment of others meet the highest quality and safety standards. These tissues and cells are increasingly travelling between countries. We want a safety system that protects patients and supports wide access to treatments. These regulations do just that.
My Lords, I thank the Minister for explaining these regulations with clarity. I have to confess that I have form with regard to the Human Fertilisation and Embryology Authority and its regulations which goes back to when I first arrived in your Lordships’ House 20 years ago. I have been involved in the development of these regulations at each stage as a Back-Bencher or a Health Minister or in opposition. The meticulous attention that this House has given to these matters at each stage is one of the reasons why we are a world leader in the use of embryos and human tissue to advance medical and fertility science, and we should be proud of that.
Like my honourable friend Sharon Hodgson in the Commons, we on these Benches will be supporting the updating and tightening of the regulations that these statutory instruments contain. It is important that these objectives support our aim of making sure that human tissue is stored and used safely, ethically and with proper consent, and is moved properly. I am pleased that the chief executive of the Human Tissue Authority, Allan Marriott-Smith said:
“We are committed to working with our stakeholders to ensure a smooth transition and proportionate approach to implementation”.
I have two questions for the Minister. First, how will that implementation be monitored by the Government? I am not actually expecting her to answer my second question today but I would like the Government to address it. Her remarks and those of her honourable friend the Minister in the Commons show, in almost their first sentence, that these regulations are being laid as a result of a European directive, so she will not be surprised that my question relates to that. In the Commons, the Minister’ said:
“the regulations fulfil a UK obligation as a current member of the European Union. More importantly, they bring into UK law provisions to enhance our already robust controls”,—[Official Report, Commons, Third Delegated Legislation Committee, 31/1/18; col. 4.],
and so on. The Minister must therefore have anticipated that my question is: what will happen to these regulations and to this function after Brexit? Are those discussions in hand? What is their timescale? If the Minister does not have those answers to hand, I am very happy for her to write to me about them.
My Lords, I thank the Minister for her introduction. I do not intend to detain the Committee long. These two regulations are, I suspect, the first of many health regulations that transpose EU law into UK law. I shall outline my understanding. As the Minister has just outlined, there are two key directives: the coding directive and the import directive, the first to ensure traceability and the second to ensure imported tissues and cells meet quality and safety standards. As I see it, the aim of these SIs is to transpose these provisions in the coding and import directives. For many patients, it is critical that this is right. What was particularly interesting in the briefings were the impact assessments that accompanied them. The transition tables enable clarity about how elements of EU legislation are put into UK law and allow us to match one for one to ensure that nothing has been altered or omitted. As far as my inexperienced eye could tell, that has been achieved. Another interesting point is the cost to the sector of the work to achieve this.
I have a few questions for the Minister, of which I have given her prior notice. Will she tell the Committee what consultations were done and with whom? What practical changes will the sector see and how long is the sector allowing for such changes to take place, if any? What cost implications are there for both organisations? Much work has been done. Was it budgeted for in their income when they were funded or has the cost had to be found from existing budgets?
As I said earlier, these are our first regulations, and I wonder whether the Minister could tell us how many more to expect and the likely total cost of this exercise to the NHS. Does she anticipate that we will be able to process these changes before leaving the EU? Does she have any indication of whether this exercise is prioritised, or do the regulations come as they are available? I spoke to both the HFEA and the HCA and they are both content with these regulations, so we are also happy to endorse them.
My Lords, I congratulate my noble friend on the elegant way in which she dealt with a very difficult issue. The only reason why I am speaking is that on every occasion we should draw the attention of the House to the fact that merely taking EU legislation into British law does not actually meet the case, because that is of no use unless there is equivalence. We cannot in future operate as if we could operate on our own, because the whole purpose of this legislation is that we can pass these things without difficulty across the whole of the EU.
I do not expect my noble friend to answer what I have to say. As I said, I thought her presentation of this difficult situation was as elegant as it is humanly possible to be. But we cannot escape the fact that this is another example where leaving the EU does not solve problems but causes really serious ones. When she said that we are looking for equivalence, I have to say that there is nothing else that we could look for because nothing else would meet the needs. Anything else would cease to enable us to use these very important elements across the whole of the EU; we would have our own system.
I have just spoken to the Society of Motor Manufacturers and Traders, and again I had to say that the idea that Britain is going to have her own rules about the carbon exhausts of vans is just barmy because we are not big enough to do that. Here, similarly, what we are seeing in reality in this SI is the serious damage that is being done by this whole enterprise. Although it may bore Ministers and some of my colleagues on this side of the House to be reminded of it, I do not think any of these should be passed without reminding people of the huge cost, the vast inconvenience and maybe even the lives that will be endangered by behaving as stupidly as we are by believing that we can operate without a connection with our neighbours. Indeed, we do not believe that; that is why the answer is that we will look for equivalence. If you look for equivalence, of course, what you are really doing is saying that the rules will be made by someone else and we will merely accept them.
I thank all noble Lords for taking part in this debate. It is a great pleasure to have the noble Baroness, Lady Thornton, here, because she is a great expert on these regulations. The reason why we in this country are so expert on these particular issues is probably that the noble Baroness helped to take the regulations through in the first place.
The noble Baroness asked whether we monitor. The department meets the HFEA and the HTA, and implementation will be on the agenda for discussion on a regular basis. On her other question, I might have to write to her if that is all right.
The noble Baroness, Lady Jolly, asked several questions, including one on the consultation. As I mentioned in my speech, the Department of Health and Social Care set up a stakeholder advisory group that included representation of professional bodies, tissue banks and service providers to give guidance on transposition and the potential impact on licensing establishments. I am also aware that the regulators, the Human Tissue Authority and the Human Fertilisation and Embryology Authority, have done a lot of work on the development of these regulations and preparing licensed establishments for implementation, and I am grateful to them for that.
There was also a public consultation exercise which ran from 10 March to 7 April 2017. The question in the consultation document focused on practicalities and implementation, such as whether new IT systems would be required for coding and what the potential cost of compliance would be. Fifteen responses were received, largely from the non-reproductive cell sector. The responses made useful suggestions on a number of operational issues, including the practical implementation of exemptions.
The noble Baroness asked about practical changes. Licensed establishments will now use the single European code, so for the first time any licensed establishment anywhere in the EU will be easily able to read the code and know what tissue is in the package, where it came from and its use-by date. Licensed establishments will also now have written agreements with exporters outside the EU that spell out who is responsible for each safety requirement. For the first time the regulators must be allowed to inspect the exporter’s paperwork and even the premises themselves. These provisions come into force from 1 April 2018 and the regulators have been supporting the sector to prepare for the implementation.
The noble Baroness also asked about costs. We expect that most establishments in the fertility sector will fall under the exemptions and therefore expect the cost to the HFEA will be negligible. In the non-fertility sector, the HTA reviews fees on an annual basis to reflect the costs of licensing and any marginal costs associated with the implementation will be included in this assessment. She asked how many more regs were necessary. The main regulations on the safety and quality of tissues were introduced in the UK in 2007 so the regulators and the sector are very familiar with implementing safety and quality standards. The main directive sets out the overarching framework and makes provision for four further commission directives to set out detailed provision of the requirements. These regulations are the final tool in that series.
The noble Baroness mentioned timing and benefit. These regulations will come into force this April and are not being introduced as a result of the decision to leave the EU.
I did not mean to mislead the Minister, I just anticipated that many more regs would need a similar sort of exercise to that we have done today—in the NHS health sphere and in general. The question was really about workload: how many more do we expect to come down the track, when do we expect them to come and are we anticipating that they will be finished by Brexit date? Is there any indication that they are being done on a slightly ad hoc basis or are some being prioritised over others? I am sorry if the Minister is unable to answer that now, but if she wants to write to me, that will be fine.
I cannot give a timing on that now so I will have to write. These regulations needed to be dealt with anyway and they are slightly late, partly due to a general election, so we have to put them in place now. It actually has nothing to do with Brexit. We have to put them in place now, otherwise we would have heavy fines. In a way, that slightly answers the question from my noble friend Lord Deben about why we are doing it. We are making sure that our standards are as high as those of other EU countries, so this is actually transposing existing regulations and making us consistent with the EU; we are not adding anything new.
The logic is that if the EU then changes regulations in this area, the UK will also change the regulations here, because of the point made by the noble Lord, Lord Deben. Or are we, having established that currently we will remain with European regulation, going to go out in Dr Fox’s brave new world and develop our own provisions?
No. We have to do these regulations anyway, that is the point. They should have been implemented on 29 April 2017 and, as I said, the delay was due in part to the complexity of the directives themselves—other member states have also experienced delays—and the initial timetable to make the regulations before the Summer Recess was paused because the general election was called in March 2017 and we then had a recess period. That is why we are doing the regulations now.
I think I have answered all noble Lords’ questions, so I commend the regulations.