Draft Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019
Draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
Draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
(Limited Text - Ministerial Extracts only)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)
I beg to move,
That the Committee has considered the draft Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019.
The Chair
With this it will be convenient to consider the draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019 and the draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019.
Jackie Doyle-Price
It is a pleasure to serve under your chairmanship this morning, Mr Stringer—even though it is a bit early for some of us.
We are debating three sets of regulations that will be critical to maintaining patient safety in respect of organs, tissues and cells used to treat patients as we leave the European Union. They are no-deal statutory instruments: they have been developed as part of contingency planning and will be needed in the event that we leave the EU with no agreement in place. If the UK reaches a deal with the EU, the Department will revoke or amend the instruments to reflect the deal. The instruments will ensure that UK law on organs, tissues and cells functions effectively after exit day and maintains the same high standards of safety and quality. The instruments are being made under the European Union (Withdrawal) Act 2018. They make appropriate amendments and revocations to correct deficiencies in UK law and retained EU law.
I will go through the amendments in detail. First, in the event of no deal, the UK and the EU will consider each other to be third countries; the regulations redefine the term “third country” to include EU countries and Gibraltar. As a result, licensed establishments will need to make administrative changes to continue to import organs, tissues and cells from EU countries and Gibraltar.
A small number of organs are shared with EU and non-EU countries, with fewer than 30 organs on average being imported or exported each year. Despite the small numbers, we need to ensure that an appropriate legal regime is in place. Tissues and cells are imported from and exported to EU countries less often than they are imported from and exported to countries outside the EU. There are about 5,000 imports of tissues and cells from the EU in a typical year. That includes about 600 imports of stem cells and 3,000 imports of bone products. The UK imports donated sperm primarily from commercial sperm banks in the USA and Denmark.
Secondly, the regulations amend a number of references in current UK legislation that will no longer be appropriate once the UK withdraws from the EU. That includes references to obligations with which the UK must comply as an EU member state and some references to the EU, the European economic area, the European Commission and EU law. The regulations also modify how some of the requirements in the directives, which are referred to in domestic legislation, are to be read post exit.
Thirdly, these instruments propose a conferral of powers from the Commission to the Secretary of State and the devolved Administrations, where that is within devolved competence, permitting the Government to respond to emerging threats, changing safety and quality standards and technological advances. Legislative competence for the donation, processing and use in treatment of human reproductive cells—sperm, eggs and embryos—is reserved to Westminster. Competence in respect of all other human tissues, cells and organs is devolved; the relevant instruments are being made on a UK-wide basis, with the agreement of the devolved Administrations. The proposed amendments have been fully discussed with the Scottish, Welsh and Northern Irish devolved Administrations, and they have given formal consent to the draft statutory instruments.
The instruments are intended to maintain the current regulatory framework, so that UK organisations such as hospitals, stem cell laboratories, tissue banks and fertility clinics will continue to work to the same standards that they worked to prior to our leaving the EU. The impact of the instruments on businesses and public bodies will be low. Only establishments that import from or export to EU countries will be affected.
There is no impact for organ transplant centres. NHS Blood and Transplant and the Human Tissue Authority are working together to ensure that the new arrangements are put in place properly. Licensed establishments that import tissues and cells will need to put in place new agreements, so that they can continue to import tissues and cells from EU countries. The draft regulations give a six-month transition period so that they can do so. UK regulators will continue to advise and support all tissue establishments in preparing for exit day.
The draft regulations will allow us to continue with business as usual while leaving the European Union. I commend the draft regulations to the Committee.
Jackie Doyle-Price
It is a pleasure to follow the right hon. Member for Don Valley. I do not think I disagreed with a word she said. I recognise that, for some Members, it is a matter of regret that we are leaving the European Union. None the less, we are committed to delivering the instruction given by the British people in the referendum. I think I speak for most people in the room when I say we would prefer to do that on the basis of an agreed deal with our European allies, but we need to be ready for the eventuality that we are not able to secure such a deal. That is why we introduced these SIs. I am grateful to Committee members for their pertinent questions. They are evidence—if only the public could see it—of how seriously we are taking the challenges of a no-deal Brexit, which of course we all wish to avoid as best we can.
A number of Members expressed concerns about whether affected establishments had been properly communicated with and were ready for the changes in these regulations, and about costs. We issued a technical notice to all affected parties in August to give them due notice to be able to prepare for the regulations. As was referred to, there is a six-month implementation period, but we expect that preparation to have been undertaken now. Given that it effectively will be business as usual, we expect that preparation to be relatively straightforward. Some of the things we have put in, such as the six-month transition period, are really just a sort of legal process to set deadlines, but we expect all those affected to be compliant almost immediately.
On the issue referred to in the technical notice of whether establishments might need to seek separate advice, we expect establishments just to engage with the regulators. Again, this will be business as usual, but the regulators stand ready to give all those affected as much advice as they need to be able to comply.
The hon. Member for Gedling is quite right that the updated information was not published in November, but it has now been published. It was published on 7 December, so it was slightly delayed—that is not unusual when it comes to things associated with Brexit—but it can be found online, and I will draw his attention to it.
Jackie Doyle-Price
Google has its limitations, it has to be said.
On whether costs need to be reimbursed, it is worth noting that we expect the costs incurred by establishments to be extremely low. The main impact of the draft regulations relates to agreements that establishments have to put in place with whomever they trade with, but most establishments already hold import licences and are well used to making and applying such agreements. We expect them simply to roll over their existing written agreements. Again, however, NHSBT and the Human Tissue Authority will work with and support establishments to put those agreements in place. There will be no impact on organ transplant centres, and in the case of non-reproductive cells we think all the establishments concerned will already have such agreements in place. On that basis, we do not expect any establishment to incur significant costs, so there will be no need for any reimbursement.
The right hon. Member for Don Valley and the hon. Member for Washington and Sunderland West mentioned organ donation. Clearly, the 30 organs that come in and out of the country every year are a matter of life and death. It is of considerable concern to me that we have sufficient provision in place to ensure that that can continue. Much of that movement is between the Republic of Ireland and the north, and at this stage we do not anticipate significant problems there, but there is good reason to worry about Dover-Calais.
We have all heard the concerns about whether things will be able to get into the UK through that entry point. We are working with the Department for Transport to ensure that things such as medical supplies, including organs, can get through if there is traffic congestion. We are making such provisions—contingency plans will be in place. I hope we do not get to the point of having no deal, but we are determined to ensure as best we can that, if we do, it will be business as usual and that, for example, couriers are escorted so they can navigate traffic more quickly. It is very much on our agenda to ensure that we can enable that to happen.
Question put and agreed to.
draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
Resolved,
That the Committee has considered the draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)
draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
Resolved,
That the Committee has considered the draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)