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Our reponse to the EPAC consultation on cross border genetic testing of rare disease in the European Union
The European Public Affairs Committee (EPAC) held a consultation on their recommendations on cross border genetic testing of rare diseases in the European Union.
The UK Genetic Testing Network (UKGTN) promotes equity of access to genetic testing for rare conditions, and ensures that the highest possible standards are upheld in genetic testing in the UK. The recommendations of EPAC seek to do the same, improving the continuity of genetic testing in Europe.
Here you can find our response to their recommendations. We point to the UKGTN as setting a great example of how genetic testing could take place across Europe. Genetic Alliance UK has also highlighted some concerns about the recommendations.
Our response to the Academy of Medical Science's call for input on their project looking at public health in 2040
Healthcare in the UK faces many challenges in the coming years, such as an aging population and health inequalities. The Academy of Medical Sciences’ ‘Health of the public in 2040’ working group project has been exploring the ways in which the future problems in health for the UK population can be addressed. The ‘call for input’ from the Academy of Medical Sciences, gave Genetic Alliance UK the opportunity to contribute ideas about what the future of healthcare might look like for people with genetic and rare conditions. You can read our response here.
Our response to the Northern Ireland Department of Health, Social Services and Public Safety's consultation on the Individual Funding Request process
Often rare conditions are serious and life-limiting but have no treatment or cure available. This means that when a new therapy does come along, it is important that they get to the patients that will benefit from them as quickly as possible. The Northern Ireland Department of Health, Social Services and Public Safety (DHSSPSNI) have conducted a consultation on their Independent Funding Request (IFR) process after concerns were raised from stakeholders, charities and others. You can read their proposals in full here.
Genetic Alliance UK has seen that the IFR process can routinely prevent rare disease patients from being able to access the treatments that they need for a number of reasons. One of the most important is that for a successful IFR application a patient must demonstrate that they are exceptional from other patients with the same condition. Rare conditions often have variable symptoms, symptom severity and rate of progression, which can make demonstrating that you are 'exceptional' very difficult. More importantly though, most rare disease treatments have not yet been looked at by a technology appraisal body and so there is no formal way for a patient to access them on the NHS. This can mean that whole groups of patients with the same condition are requesting the same treatment through the IFR route as it is the only option available to them. Because this contravenes the 'exceptionality' criteria, the whole group of patients have their IFR applications refused so that they are still unable to access the new treatment they need.
Genetic Alliance UK's response highlights this ongoing issue for rare disease patients and the IFR route, and comments on the other proposals from the DHSSPSNI. You can read it in full here. We continue to work on the IFR processes of all four home nations of the UK where the exceptionality criteria is resulting in rare disease patients being routinely denied treatment on the NHS.
Our response to the UK National Screening Committee's consultation on screening for Fragile X during pregnancy
Fragile X syndrome is a genetic condition and is the most common known cause of inherited learning disabilities. It affects around 1 in 4000 boys and men, as well as 1 in 6000 girls and women. Fragile X is diagnosed by genetic testing. The UK National Screening Committee (UK NSC) is responsible for assessing the risks and benefits of introducing new population-wide screening programmes. Genetic Alliance UK have responded to the UK NSC's consultation on its recommendation not to screen for Fragile X in pregnancy. You can read our response here.
Our response to NHS England's consultation on their clinical commissioning policy for Uveitis
Uveitis is a rare, serious condition that can lead in severe cases to permanent eye damage and loss of vision in children and adults. For many patients the previously available methods of treating the condition have no impact or are associated with adverse effects. More recent drugs, infliximab and adalimumab, are considered effective treatments for these conditions. After large numbers of Independent Funding Request (IFR) applications were submitted for the medicines, NHS England produced a clinical commissioning policy for both infliximab and adalimumab. Our consultation response on their clinical commissioning policy can be found here.
Our response to NHS England's consultation on genetic testing for BRCA1 and BRCA2 mutations
Having a mutation in the BRCA1 or BRCA2 genes can increase the risk of developing some cancers, particularly breast and ovarian cancer. Knowing whether you carry a mutation in either BRCA1 or BRCA2 can change how your cancer is treated or can allow you to decide whether you want to undergo any available interventions to help reduce the risk of developing cancer. NHS England commission genetic testing for BRCA1 and BRCA2 in individuals who have more than a 10% risk of having the gene mutation, which is calculated based on family history of BRCA gene related cancers. Genetic Alliance UK have responded to NHS England's consultation on their commissioning policy for genetic testing for the BRCA1 and BRCA2 genes, which sets out who will be offered this test on the NHS. Read our response here.
Our response to NHS England's consultation on their new Genomic Laboratory Services infrastructure
Many patients affected by rare conditions do not receive an accurate diagnosis for many years, and may be misdiagnosed multiple times during that period. We also know through our initiative SWAN UK (syndromes without a name) just how scary and frustrating is can be as a parent or family living with a child who is unwell and has an undiagnosed condition. Genetic testing is vital for the many patients and families affected by rare genetic diseases in order to help get them an accurate and timely diagnosis for their condition. The NHS has just completed their consultation on changes to the Genomic Laboratory Services infrastructure, which they hope will help expedite diagnosis for rare conditions. Our response can be read in full here. Our response has been shaped by the findings of our Patient Charter “Genome sequencing: what do patients think?”, which you can read here.
Our reeponse to the UK NSC: Screening for FAOD consultation
Genetic Alliance UK encourages the UKNSC to establish a pilot screening programme for Carnitine Transporter Deficiency (CTD) and Very Long-Chain AcylCoenzyme A Dehydrogenase Deficiency (VLCADD). As these conditions are already part of newborn screening in the USA and several European countries, it is likely that the pilots would be successful and provide the UKNSC with sufficient evidence to support the introduction newborn screening for CTD and VLCADD in the UK, particularly as treatments for these conditions are already available. Read our response here.
Our response to the UK NSC: Screening for AAMD consultation
Genetic Alliance UK encourages the UKNSC to establish a pilot screening programme for citrullinaemia and argininosuccinate lyase deficiency. As both of these conditions are already part of newborn screening programmes in the USA and six European countries, it is likely that the pilots would be successful and provide the UKNSC with sufficient evidence to support the future introduction of newborn screening for citrullinaemia and argininosuccinate lyase deficiency in the UK.
Genetic Alliance UK supports the implementation of newbornscreening for tyrosinaemia I. The fact that no feasibility studies for screening for tyrosinaemia I at birth have been carried out in the UK should not stand in the way of the UKNSC recommending newborn screening for this condition using the most effective screening methodology in line with recent advances in this area. Read our response here.
Our response to the UK NSC: Screening for Galactosaemia consultation
Genetic Alliance UK supports the position of our member, the Galactosaemia Support Group, and would welcome the implementation of a formal newborn screening programme for Galactosaemia. The Galactosaemia Support Group have reached this position based upon patient experience and on the review held by their Medical Advisory Panel. Read our response here.
Our response to the EMA: Application of transparency rules of EU Clinical Trial Regulation consultation
The Patients Network for Medical Research and Health (EGAN) speak on behalf of patients when we welcome greater sharing of clinical trial data throughout the union due to opportunities this will provide to improve our understanding of rare diseases and therefore our ability to develop new treatments. In this consultation response we call for clarification on what is meant by 'personal data' and how that relates to whether the data is personally identifiable. We ask for expansion on what constitutes 'overriding public interest'. EGAN believes that the EMA and the pharmaceutical industry should be as transparent and open as practicable. We recommend that the regulations that govern which data are made publicly available on the EMA database should mirror the consent patients give when agreeing to participate in the clinical trial itself. Read our response here.
Our briefing on abortion for fetal sex
We have joined forces with Antenatal Results and Choices to produce a briefing against an amendment to the Serious Crime Bill which may limit reproductive choices for women at risk of having a child affected by a serious genetic condition. Read our briefing for MPs here.
Launch of our patient charter on genome sequencing
Today we are launching our third patient charter. This time our focus is on patient attitudes to genome sequencing. You can download a copy of our charter and find out more here.
Launch of our report on improving access to specialised services and therapies for Welsh patients
Today we are co-hosting an event with the AKU Society at the National Assembly building in Wales in order to raise awareness of the benefits to patients with rare diseases of gaining timely access to specialised services and therapies. We have received a number of reports from our patient group members in Wales regarding the difficulties their patient community can face in trying to access specialised services and treatments in Wales, or to get the referral they need to access those services elsewhere in the UK.
As part of the event, our Director, Alastair Kent OBE, will be launching our report on ‘Improving access to specialised services and therapies for Welsh patients’. The report makes 14 recommendations that aim to address the current barriers to accessing to specialised treatments and services, including new medicines and diagnostic genetic tests, both within Wales and though referrals to UK specialists. You can download a copy of the report here.
Our response as EGAN to the European Medicines Agency's consultation on replacing, reducing and refining the use of animals in medical research
The use of animals in medical research is a contentious issue, dividing opinion on moral and ethical grounds. The European Medicines Agency (EMA) held a consultation on the regulatory acceptance of the '3R' testing approaches: the 3Rs are replacement, reduction, and refinement. This means using methods which avoid or replace the use of animals where realistically possible, methods which minimise the number of animals used per experiment, and methods which minimise suffering and improve animal welfare. Genetic Alliance UK worked with the Patient’s Network for Medical Research and Health (EGAN) to highlight the need for investment in the 3Rs. You can find our full response to the EMA consultation here.
Our response as EGAN to the European Patients Forum regarding the communication of the lay summary for clinical trial results
In the past, the results of clinical trials have not always been reported in full, data has not been published or researchers have been selective in what they report. The rare disease community have a special interest in this problem. There are often no, or very few, treatments for rare conditions, therefore, when medicines are trialled for the treatment of these conditions there is great interest within the rare disease community as to whether that medicine has been effective in reducing symptoms, slowing the progression of their condition or reducing mortality.
New EU Clinical Trials Regulation requires that all clinical trials in the EU must be registered in a new database and the results published, including a summary that is understandable to ordinary people. Genetic Alliance UK, on behalf of the Patients Network for Medical Research and Health (EGAN) has responded to the European Patients Forum's (EPF) member consultation on the communication of the lay summary. EGAN has supported the calls for guidelines to be implemented at an EU level for lay summaries and calls for the formation of a defined working group involving all interested parties, including patients, patient representatives and members of the wider public to produce guidelines to be developed at EU levels. Read the full response here.
Our response to the World Health Organisation's consultation on their International Clinical Trials Registry Platform (ICTRP)
Recently, there has been much discussion around the disclosure of clinical trial data and what can be done to improve transparency and ensure all trial outcomes, whether positive or negative, are made publicly available. The World Health Organisation (WHO) has taken steps to address this issue by developing an International Clinical Trials Registry Platform (ICTRP), where information about clinical trials from around the world can be recorded and viewed.
Genetic Alliance UK has responded to the WHO consultation on their proposals to highlight how important reporting and sharing clinical trial data is to the rare and genetic disease community, particularly when so many rare conditions have no treatment and rely on clinical trials to identify new therapeutic options. Our response also emphasise the need to ensure that rare disease trials are not routinely excluded from the ICTRP on the basis that small numbers of trial participants can increase the likelihood of individual identification from summary data if it is made public. You can read the full response here.
Our response to the UK National Screening Committee's consultation on introducing newborn screening for Gaucher disease
The UK National Screening Committee (UK NSC) make decisions about population-wide screening programmes, including which conditions should be screened for at birth as part of the bloodspot newborn screening programme. Genetic Alliance UK, and other stakeholder groups, have taken part in the review process for the UK NSC’s recommendations on screening for Gaucher disease in newborns. In our response, we supported the view of our members, the Gauchers Association, who after surveying patients and families recommended that newborn screening for Gauchers was not introduced at the present time. We suggested, though, that the UK NSC should further explore the potential value of newborn screening for Gaucher type 2 and type 3. In our response we also highlighted the importance of screening and early diagnosis to reproductive choice and the importance of patient/familial voice in the UK NSC appraisals process. You can read our full response here.
Our response as EGAN to the European Medicine Agency's consultation on EU portal and EU database
In the new EU Regulation on clinical trials, the EMA was made responsible for developing and maintaining the IT platforms (the EU clinical trials portal and EU database) that will support the submission, assessment and supervision of clinical trials in the EU.You can read their proposal here.
In our response we emphasise the value for the rare disease community of sharing clinical trial data as, perhaps more than those affected by more common conditions, rare disease patients rely on the collection and sharing of data across national boundaries in order to establish a useful evidence base. We recommend that the EMA ensure that rare disease trials are not routinely excluded from inclusion in the database on the basis that there is a higher risk of individuals being re-identified from trial data. We note that when rare disease patients consent to participating in a clinical trial they have already understood the risk of re-identification and have decided that the benefits of the trial for themselves as individuals, as well as for others affected by their condition, outweighs this risk. Our full response can be read here.
UK National proposals for a sustainable cancer drug fund consultation response
The Cancer Drugs Fund (CDF) is money taken from NHS England's budget that is set aside to pay for cancer medicines in England that haven’t been recommended by the National Institute for Health and Care Excellence (NICE). This may be because NICE have not looked at the medicine yet or because they found that it did not work very well or was not cost effective. In 2013/14 the CDF overspent by £30.5 million and the money needed to cover this expense was taken from NHS England’s specialised commissioning budget that pays for medicines and services for all those affected by rare conditions, including rare cancers. NHS England has been consulting on new operating procedures for the CDF that means that in order to be funded by the CDF, the medicine must show that it is clinically and cost effective. In our response, we support the change in that it creates a more level playing field between those patients affected by cancer and those affected by many other conditions that rely on NHS England funding for their treatments. Our response to their consultation about the proposed changes can be found here.
UK National Screening Committee Screening for Gaucher Disease - an evidence review consultation response
Genetic Alliance UK supports the recommendation of the Gaucher Association’s response to this consultation that at this present time no formal Screening Programme should be implemented for Gaucher Disease.
However, we believe it would be valuable for the UK NSC to examine the potential value of introducing a screening programme that looked to diagnose type 2 and type 3 affected individuals by testing for the genetic mutations that have been linked to these conditions.
Moreover questions must be raised about UK National Screening Committee current methodology which places a premium on peer reviewed literature to the exclusion of all other forms of evidence. We note with particular concern that in this instance the literature review is two years out of date.
Our response on behalf of EGAN to the European Medicine Agency's consultation on the conduct of public pharmacovigilance risk assessment hearings
The EMA has been consulting on how it should regulate public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC). Their proposed rules and procedures can be read here.
The PRAC is the committee at the EMA responsible for assessing and monitoring safety issues for human medicines. As we outline in our response, we believe that in the proposed procedures the EMA has overestimated the likely interest from the wider public while placing too little emphasis on the views of patients who will have direct experience of the medicine in question. We call for the EMA to amend the proposals so that the patient voice is considered as distinct from the views of the wider public and to require proactive engagement from the EMA with the patients and clinicians that have had direct experience of the medicine in question. You can read the full response here.
Our response to the Department for Business, Innovation and Skills consultation on developing a new Science and Innovation Strategy
The Department for Business, Innovation and Skills plan to produce a new Science and Innovation Strategy in 2014 and have asked for comments on their proposals from interested parties.
Genetic Alliance UK took the opportunity to highlight the importance of a vibrant research community to rare disease patients who look to research and innovation to address their unmet medical need with new treatments and therapies. Furthermore, as we better understand how common conditions can be broken down into smaller subgroups defined by genetics and biomarkers, more and more conditions will be classified as 'rare', allowing greater personalised treatment. The UK therefore needs to develop a research structure that works for rare conditions and is prepared for the breakdown of common conditions into many rare subtypes.
By developing a strategy that complements the UK Strategy for Rare Diseases, the Science and Innovation Strategy will be sustainable, relevant and supported by the implementation of the Rare Disease Strategy's commitments. Our full response can be read here.
Our response to the Department of Health's consultation on protecting health and care information
The Department of Health has proposed a set of Regulations that introduce tighter controls and safeguards on the use of personal health and care data. Data sharing is an essential driver of medical research into rare conditions and ensures that the NHS is able to plan for and provide the treatments and services rare disease patients need. We therefore support a clear, functional system that can facilitate data sharing for patient benefit rather than restrict it, while reassuring those that participate that their data will be stored and shared safely and accountably. In our response, we raise our concerns that the proposed Regulations will instead make it more difficult for rare disease patients in particular to share their data and therefore benefit from the outcomes. In line with the commitments made in the UK Strategy for Rare Diseases, we also ask in our response why the Regulations do not specifically outline how patients will be able to access their own health and care data. Read our full response here.
Genetic Alliance UK supports the post of Chief Scientific Adviser to the European Commission President
We are supporting the maintenance and strengthening of the role of Chief Scientific Advisor to the European Commission President, along with the European Genetic Alliance Network (EGAN), Cancer Research UK, Alzheimer’s Research UK, Association of Medical Research Charities, Wellcome Trust, NHS Europe office, Arthritis Research UK, International Brain Tumour Alliance – IBTA, Parkinson’s UK.
Our response to the UK National Screening Committee's triennial review
The UK National Screening Committee (UK NSC) has recently completed a consultation on their role and processes as part of the review they undertake every three years. The UK NSC make decisions about population-wide screening programmes, including which conditions should be screened for at birth as part of the bloodspot newborn screening programme.
Our response to their consultation raises a number of concerns we have about the lack of patient engagement in the process and their exclusion of evidence that is not published in peer-reviewed journals. We feel that for rare diseases this means that much of the most up-to-date information available on the nature of a condition and the experience of diagnosis without a screening programme is absent from the UK NSC's considerations. You can read our full response here. You can also find out more about the consultation by watching our video.
The UK National Screening Committee (UK NSC) makes decisions about which conditions to screen the UK population for. Every three years they review their role and the processes they use for making their decisions. As part of this review, the UK NSC is holding a consultation so that interested parties can feed their views into the review process.
The last day for submitting your response is the 8th July 2014.
Genetic Alliance UK will be responding to the consultation and we would like to encourage as many of our members as possible to do the same. To help, we have made the information video below.
The video gives background information on the UK NSC and explores some of the issues raised in the consultation. It includes video interviews with Pat Roberts from Save Babies Through Screening Foundation; Jane Field, whose son wasn’t diagnosed with Duchenne Muscular Dystrophy until he was seven and a half; and Nick Meade, Genetic Alliance UK’s Director of Policy.
Genetic Alliance UK's response to NICE's consultation on value-based assessments
NICE has recently outlined their proposals for value-based assessment (VBA). This process will replace original plans to introduce value-based pricing (VBP) and will determine how all future medicine appraisals are carried out at NICE. A consultation was held to gather the opinions of interested stakeholders and Genetic Alliance UK has prepared a response, which you can read here.
As we outline in our response, NICE’s VBA proposals are a missed opportunity. Burden of Illness (BoI) and Wider Societal Impact (WSI) presented a framework within which NICE could formalise consideration of additional factors beyond those already captured by Quality Adjusted Life Years (QALYs) in order to achieve a more accurate representation of a medicine’s value as perceived by patients, their families and carers and wider society. Relying on further manipulation of QALYs, already an imperfect measure of patient health gain, does not achieve this and merely represents a reshuffling of NICE’s existing priorities.
Consultation response: The Medical Innovation Bill
Genetic Alliance UK actively supports research and innovation across the field of genetic medicine. In this capacity, Genetic Alliance UK has endorsed the Manifesto For Patient-Driven Medical Innovation developed by Centre for the Advancement of Sustainable Medical Innovation (CASMI). Genetic Alliance UK also welcomed the introduction of NHS England’s ‘Specialised Services Commissioning Innovation Fund’, before the initiative was suspended.
There is much more that could and should be done to address the barriers that currently inhibit theadoption and integration of research and innovation into the NHS.
To see our full response please click here.
Launch of Genetic Alliance UK’s Patient Charter - endorsed by 77 patient group members like you!
Thank you to all those who endorsed and helped support the launch of Genetic Alliance UK’s Patient Charter last week. It was great to see so many of you getting behind the launch on Twitter and by posting blogs onto your website. The greater the support for this Patient Charter, the more powerful it will be for enacting positive change, so thank you.
If you are yet to produce a blog on the Charter for your own website but would like to, please feel free to get in touch with who will be happy to send you an example template and provide you with more information.
The Patient Charter was produced following a workshop hosted by Genetic Alliance UK for representatives of its patient group membership and was subsequently endorsed by 77 of Genetic Alliance UK’s patient group members.
It highlights the concerns patients have that the new approach the Government and NICE are using to determine whether or not medicines for very rare conditions are made available through the NHS is opaque, potentially disruptive to the wider NHS and risks downplaying the patient voice. The new process is NICE’s Highly Specialised Technologies (HSTs) evaluation programme.
The Patient Charter was launched at a breakfast meeting co-hosted by the Association of the British Pharmaceutical Industry (ABPI) and BioIndustry Association (BIA) at their headquarters in central London. It was chaired by Alastair Kent OBE (Director, Genetic Alliance UK). On the panel were Steve Bates (BIA), Josie Godfrey (NICE), Dr Robin Lachmann (National Hospital for Neurology and Neurosurgery) and Frances Macdonald (ABPI).
The launch was a fantastic opportunity to have all the key stakeholders in one room to constructively discuss the issues raised by patients in the Patient Charter. Each of the panel members were first invited to give their views on the Patient Charter’s findings, before representatives from patient groups, the pharmaceutical industry, NICE and NHS England were then given the opportunity to ask questions. This led to a lively and diverse discussion and it was great to see all the stakeholders engaged in such a thought-provoking and productive meeting.
Genetic Alliance UK are now following up the progress made with the Patient Charter by ensuring it is taken into account in NICE’s review of the HST evaluation process, which is expected before the end of the year.
Genetic Alliance UK are also starting to plan their next Patient Charter. This will also be looking at access to medicines for rare diseases but will take a much broader scope, examining all the potential routes of medicine appraisal and commissioning in order to add clarity and highlight any gaps or inconsistencies.
Read a Storify of the event using this link.
Check out the analysis by the Bioindustry Association here.
- Biocentury: Patient group wants more NICE transparency on rare diseases
- Bioindustry Association: 77 patient groups come together to call for NICE to improve the way it evaluates rare disease drugs
- Duchenne Campaigns: Patient Charter for the NICE evaluation process of rare disease treatments event with Genetic Alliance UK
- Charter for improvements in rare disease drug evaluation launched
- Muscular Dystrophy Campaign joins call to address concerns on rare disease drugs evaluation process
- Patient Groups Unite on Access to Medicines
- Genetic Alliance UK Launch Patient Charter Outlining
- Alkaptonuria Society hosts a blog by Genetic Alliance UK's Louisa Petchey
Another step towards mitochondrial replacement therapy
The Government launched a consultation on draft regulations on mitochondrial donation last week. This is another step towards ensuring it will be possible to access this technique in the UK when studies demonstrate evidence that the technique can be trialled for the first time.
We told the press: "We welcome today's consultation launch as another vital step towards potential delivery of this intervention in the clinic. In considering the latest development, we should keep those who hope to benefit from this intervention at the forefront of our minds. The majority of these couples will have found that they are at risk of having a child with a mitochondrial DNA disease as a result of the birth of a child with the condition or because of an unsuccessful pregnancy. Their families have already been affected by mitochondrial DNA disease. This innovative treatment is their first chance to be certain that their future child will be free from a mitochondrial DNA disease. The value of this certainty to a couple is huge. We look forward to examining these draft regulations in detail and responding in due course." Alastair Kent, Director, Genetic Alliance UK.
Though this technique will only benefit a handful of our members, we see this issue as a paradigm for the future delivery of innovative treatments in the UK, so we continue to follow the issue and present the view of the patient community.
NHS England Service Specification Consultations
NHS England has launched a consultation on changes to fourteen service specifications for specialised services. These cover service specifications produced by the Renal Dialysis Clinical Reference Group (CRG), the Cardiac Surgery CRG, the Complex Disability Equipment CRG, the Paediatric Intensive Care CRG, the Neonatal Critical Care CRG and the Complex Gynaecological Services CRG. You can access the individual service specifications under consultation here. The closing date is the 21st May 2014.
This is the first wave of a rolling programme of consultations from NHS England on specialised service commissioning. Every quarter a new twelve week consultation will launch, providing an opportunity for consultation on the latest set of proposed changes from clinical reference groups.
Rare Disease implementation plan launched by the Welsh Government
On Friday, 28th February, the Deputy Chief Medical Officer for Wales, Dr Chris Jones launched the Welsh Implementation Plan for Rare Diseases at the Institute for Medical Genetics at the Heath Hospital, Cardiff. Thank you to all those were able to attend the launch event at such short notice which meant that many were unable to attend due to half term and prior commitments.
The document is now available on the Welsh Government website here. A consultation period of 12 weeks is attached to the plan and we would encourage responses to be submitted to the Welsh Government.