Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of the effect of the Legal Aid, Sentencing and Punishment of Offenders Act 2012 on the proposed fixed recoverable costs in the clinical negligence scheme.
Answered by Ben Gummer
One objective of the proposed fixed recoverable cost (FRC) regime is to improve the relationship between recoverable costs and damages paid. Looking at cases settled post Legal Aid, Sentencing and Punishment of Offenders Act 2012 we have not noticed a significant impact on this relationship.
The Department is currently preparing to go out to public consultation on the introduction of FRCs for clinical negligence claims as originally proposed by Lord Woolf and Lord Justice Jackson in 1996 and 2009 respectively. Respondents to the pre-consultation exercise in August confirmed that there is no exact correlation between value and complexity of clinical negligence claims. The consultation will include consideration of the maximum value of claims that will be covered by the FRC regime, whether there should be any exemptions; and thedate and method of implementation. The consultation is also looking at how behaviours can change to streamline and speed up the way in which clinical negligence claims are processed through the legal system. We, therefore, do not agree with the suggestion in the 9 November letter to delay the consultation whilst a review takes place.
Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will make an assessment of whether there is a causal link or correlation between the value and costs of a clinical negligence claim and its factual and legal complexity.
Answered by Ben Gummer
The Department is currently preparing to go out to public consultation on the introduction of fixed recoverable costs for clinical negligence claims as originally proposed by Lord Woolf and Lord Justice Jackson in 1996 and 2009 respectively.
Respondents to the pre-consultation exercise in August confirmed that there is no exact correlation between value and complexity of clinical negligence claims.
Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether it is his policy that costs in fatal cases involving a claim for less than £25,000, including the costs of representation at inquest, will fall outside of the proposed fixed recoverable costs in clinical negligence schemes.
Answered by Ben Gummer
The Department is currently preparing to go out to public consultation on the introduction of fixed recoverable costs (FRC) for clinical negligence claims as originally proposed by Lord Woolf and Lord Justice Jackson in 1996 and 2009 respectively. The consultation will include consideration on the maximum value of claims that will be covered by the FRC regime and whether there should be any exemptions. We will review all responses before making a final decision on these issues.
Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions he has had with University Hospitals of Leicester Trust on steps to ensure that patients with complex respiratory issues have access to specialist physiotherapy.
Answered by Jane Ellison
The Department’s Ministers have had no such discussions with University Hospitals of Leicester NHS Trust.
The commissioning and provision of National Health Services is a matter for the NHS locally.
Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions he has had with the National Institue for Health and Care Excellence on NHS commissioning of the drug Translarna, in response to the conditional approval given by the European Commission to that drug; when he plans for his review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology to be completed; and if he will make a statement.
Answered by George Freeman
Following discussions between the Department, NHS England and the National Institute for Health and Care Excellence (NICE), it was decided that Translarna (ataluren) for treating Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene should be considered for formal referral to NICE’s highly specialised technologies (HST) programme which evaluates treatments for very rare conditions. NICE has recently consulted stakeholders on the draft remit and scope of its proposed HST evaluation of Translarna.
Ministers will take a decision on the formal referral of this topic following the outcome of NICE’s scoping work.
The review of the pathway for the development, assessment, and adoption of innovative medicines and medical technologies will consider how to speed up access for National Health Service patients to cost-effective new diagnostics, medicines and devices. We anticipate an initial report before the end of the year.
Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will take steps to (a) ensure that emerging treatments for Duchenne muscular dystrophy which receive conditional approval are available through the Early Access to Medicines Scheme as early as possible and (b) encourage flexible approaches to the licensing process for potential new treatments for rare conditions.
Answered by George Freeman
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process:
- step I, the promising innovative medicine (PIM) designation
- step II, the early access to medicines scientific opinion
The PIM designation will give an indication that a product may be eligible for the EAMS (based on early clinical data) and that the development programme is on track. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
There have been no applications from companies with products for Duchene Muscular Dystrophy.
The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved. The EAMS scientific opinion is valid for one year in the first instance and lapses at this time or at the time of the grant of a marketing authorisation e.g. conditional marketing authorisation.
For certain categories of medicines going through the centralised marketing authorisation procedure (European procedure), in order to meet unmet medical needs of patients and in the interest of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally required. In such cases, it is possible to recommend the granting of a marketing authorisation subject to certain specific obligations to be reviewed annually, a conditional approval. The granting of a conditional marketing authorisation will allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case.
A conditional marketing authorisation for the first in class medicinal product Translarna (ataluren) was granted this year. Translarna is an orphan medicinal product that is used to treat patients aged 5 years and older with Duchenne muscular dystrophy (DMD) who are able to walk. Translarna is expected to slow down the loss of walking ability in DMD patients. As part of the conditional marketing authorisation, the company will be required to provide comprehensive data on the efficacy of Translarna from an ongoing confirmatory study.
Rare diseases are classified as conditions affecting no more than 5 in 10,000 people in European Union and patients with rare conditions deserve the same quality, safety and efficacy in medicines as other patients with more common conditions. Since the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing medicines intended for small numbers of patients (orphan medicinal products), the European Union offers a range of incentives to encourage the development of these medicines in order to address the unmet clinical need (orphan drug legislation, Regulation (EC) No 141/2000). These incentives include a period of 10 years market exclusivity, the provision of Protocol Assistance (scientific advice specifically tailored for orphan medicinal products) and fee reductions and waivers for regulatory procedures.
Applications for the designation of orphan medicines are reviewed by the European Medicines Agency through the Committee for Orphan Medicinal Products (COMP). For orphan designation, the following criteria must be fulfilled. The medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the European Union or without incentives it is unlikely that expected sales of the medicinal product would cover the investment in its development and no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorised, or, if such method exists, the medicinal product will be of significant benefit to those affected by the condition. Via the MHRA, the United Kingdom takes an active role in the decision making process at the COMP, ensuring applications for Orphan Drug designation of potential drug candidates for rare diseases are appropriately recognised, encouraging companies to develop their products further. For licensing, it is compulsory for designated orphan medicinal products to use the centralised procedure to gain a marketing authorisation.
The UK is fully represented at the CHMP, ensuring that applications for a Marketing Authorisation (MA) for an Orphan Drug are thoroughly and rapidly evaluated for quality, safety and efficacy and a MA is granted without undue delay for the treatment of rare diseases.
In some circumstances, marketing authorisations may undergo a more rapid regulatory review called ‘accelerated assessment’. This occurs where the Applicant can demonstrate that the medicinal product is expected to be of major public health interest (particularly from the point of view of therapeutic innovation). For drugs for rare diseases, marketing authorisation applications may be granted as a conditional authorisation or an authorisation under exceptional circumstances. The granting of a conditional marketing authorisation allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case, and ensures that additional data on a product are generated, submitted, assessed and acted upon. Under exceptional circumstances, the MA Applicant must demonstrate that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because, for example, the indications for which the product in question is intended are encountered so rarely that the Applicant cannot reasonably be expected to provide comprehensive evidence.
We are commissioning a major external review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology. This review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices.
Asked by: Lord Garnier (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what recent steps he has taken to increase awareness and early diagnosis of prostate cancer; and if he will make a statement.
Answered by Jane Ellison
The Government is investing £450 million to achieve early diagnosis of cancer through better public awareness, better screening and better access to key diagnostic tests.
Public Health England is currently running a local pilot campaign specifically targeting prostate cancer within Black African-Caribbean men, because of their significantly increased risk of developing prostate cancer. The campaign is running in six London boroughs – Hackney, Haringey, Newham, Southwark, Lambeth and Lewisham – and is mainly being delivered through face to face activity, supported by posters in key outdoor locations and in salons and a programme of targeted consumer engagement. The key message of the campaign is “1 in 4 black men will get prostate cancer. Prostate cancer often has no obvious symptoms. If you are a black man over 45 and want to discuss your personal risk of prostate cancer, visit your doctor”.