The lowdown on the growth plan…

Posted on April 7, 2011 by

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Now that we’ve had a bit more time to digest it, I thought I’d summarise the interesting bits for medical research in the government’s plan for growth, particularly which of the Academy of Medical Sciences recommendations to improve the regulation of research have been picked up, and which haven’t; what had been announced before and what was brand new; and what we’ve been promised by when…

Background

The Plan for Growth was published by the Treasury alongside the budget on 23 March. I put a quick summary of what it includes here. This builds on the growth review announced before Christmas which identified six growth areas – including healthcare & life sciences. A section of the plan for growth lays out the government plans in healthcare & life sciences and I’ve looked at the planned actions in this below.

The Academy of Medical Sciences recently reviewed the regulation and governance of health research in the UK, publishing A new pathway for the regulation and governance of health research in January 2011. This provides a comprehensive snapshot of all health research using human participants, their tissue or data in the UK and recommends changes to improve the system. There’s a short briefing on this here. The government had these recommendations when they were developing the Plan for Growth.

Who is doing what?

The Plan for growth speaks in treasury/business language, it’s all about building the economy, developing incentives and levers for investment etc. However, a lot of the actions will be taken forward by the Department of Health (DH) and by the Department for Business Innovation and Skills (BIS) and DH working together.

The Office for Life Sciences (OLS) was established to cut across DH and BIS and help them work together. It’s not clear how much of a role the OLS might play in delivery of these plans. There are a few direct mentions of OLS initiatives in the plan for growth including the NHS Life Sciences Innovation Delivery Board:

To ensure a co-ordinated approach the NHS Life Sciences Innovation Delivery Board will report to the NHS Commissioning Board in the future.

The delivery board is linked to OLS and brings together chief execs of Strategic Health Authories etc. with large pharma/medical technology and devices companies to discuss innovation and uptake of products by the NHS. But the OLS is likely to be working behind the scenes on far more. And the announcements include projects that the OLS is already working very actively on including intellectual property.

We haven’t had much detail so far on how the Department of Health is going to take these actions forward. The National Institute of Health Research (NIHR) has put a list of all the important bits relevant to them on their website.

What has happened to the Academy of Medical Sciences recommendations to improve the system?

The Plan for Growth announces that the government is going to put some of the Academy’s proposals into action.

The Academy recommended that a new, single regulator of all health research should be established called the Health Research Agency to create a one-stop shop for health research regulation. The Plan for growth confirms that the government will set this up asap as a special health authority, calling it the Health Research Regulatory Agency. At first this will provide a new home for the National Research Ethics Service (which currently lives in the National Patient Safety Agency which is being reorganised by the Health & Social Care Bill currently on its way through parliament so was in need of a new home). There isn’t much detail yet of what else will go in the new Health Research Regulatory Agency. Ultimately, this is likely to be a home for the research regulation functions of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) which are due to be disbanded. But the government is planning to consult in late summer about how their functions should be split up so we wouldn’t expect any detail on how they might fit in the research agency until after that anyway.

The Academy recommended that the new research agency should work closely with the Medicines & Healthcare products Regulatory Agency (MHRA which regulates clinical trials of medicines) so the two can work alongside each other seamlessly to regulate health research. The plan for growth confirms this:

The new agency will work closely with the Medicines and Healthcare products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.

The Academy also made lots of recommendations to simplify the process of getting NHS R&D permissions at every NHS site where research is to take place; at the moment getting permissions across multiple sites can take a very long time, with unnecessary duplication, inconsistencies and delays creeping in. Not all of the Academy’s recommended changes have been adopted in the Plan for Growth but a fair few have.

  • performance in the initiation and delivery of health research across research sites will be made transparent and accountable
  • There will be new conditions of NIHR funding. Providers of NHS services will only be able to get NIHR funding in future if they play their part in a national system of research governance by meeting requirements on timely and professional delivery of clinical trials. These new requirements will include meeting a 70 day benchmark to recruit first patients for trials.
  • Work that is already underway to reduce the current duplication in checks across NHS trusts will be launched as a framework of good practice and standard procedures called the NIHR Research Support Services in May 2011. The NIHR Clinical Research Network will work with Trusts to help get this up and running and share all the good practice already happening from the North West Exemplar Programme (this is a study of 20 industry-sponsored research projects in the NHS which are being followed closely to identify what is working and what isn’t and use this knowledge to improve practice across the whole NHS).

The Academy had recommended that the granting of NHS R&D permissions could be one of the jobs of the new single research agency. The Plan for Growth doesn’t give any detail on whether the government plan to do this and move them to the Agency once it’s set up, or whether they plan to leave them where they are. It does say

…the Government will create a health research regulatory agency to combine and streamline the approvals for health research which are at present scattered across many organisations.

The Academy also made recommendations about reforming the regulation of clinical trials, including feeding into the EU’s current review of the European legislation. The growth plan undertakes to do this and, as this change will not be quick, to look at measures they could implement in the UK to improve the current situation. The Plan for Growth also confirms that the UK Clinical Trials Gateway to make it easier for anyone who wants to to find out about clinical trials, will be up and running by 2012.

And on the use of patient data for research. The Academy’s specific recommendations on improving this don’t get a mention in the Plan for Growth but they do say that they will take action:

The Government will work with the National Information Governance Board and partners in the public and private sectors to publish plans by the autumn for a secure data service…

This may well build on work already underway through the Research Capability Programme.

Implications for the Health & Social Care Bill

As the Bill is going through the House at the moment and proposes big changes to the NHS, it is likely that some of the changes it makes might have implications for the Plan for Growth and there is some overlap.

There is only one direct mention of the bill in action 13 of the Plan for Growth:

The Health & Social Care Bill will give the NHS Commissioning Board a legal duty to promote research and innovation in the NHS and will encourage NHS, industry, academic collaborations to evaluate innovative products in a clinical setting and encourage service wide dissemination of the results.

We are concerned that this duty to promote research and innovation extends beyond just the NHS Commissioning Board across the NHS including on GPs and Monitor (the economic regulator). More detail on our concerns here.

The movement of the National Research Ethics Service (NRES) into the new Health Research Regulatory Agency announced in the Plan for Growth will require legislation in the Health & Social Care Bill to abolish the current home of NRES, the National Patient Safety Agency.

The Plan for Growth makes some proposals to enhance collaboration and the development of geographical clusters including the NHS. These may be affected by the move to greater localisation across the NHS planned in the Health & Social Care Bill. But that’s probably something that will become clearer over time..

Actions the government have undertaken to deliver

Overall, the Plan for Growth undertakes to deliver a lot and sets itself some clear deadlines. I’ve tried to summarise all the big ones below:

  • From now – The UK government will try and improve the regulation of clinical trials in the UK by reviewing our current legislation and looking at where it could be more proportionate.
  • From now – The UK government will work proactively with Europe on revision of the EU Clinical Trials Directive to make sure the revised version works better.
  • From now – The government will make up to £775 million available over the next 5 years  to be invested in translational research through the National Institute of Health Research (NIHR). Announced previously.
  • This year – establish the Health Research Regulatory Agency as a Special Health Authority
  • May 2011NIHR Research Support Services will be launched – a framework of good practice and standard procedures to help NHS trusts work together better regulating and governing health research.
  • Spring 2011Cogent will present a package of measures aimed at improving biology training to government. (this has been announced previously and comes from work begun by the Office for Life Sciences)
  • Spring 2011 – the government will publish an updated Intellectual Property Strategy Handbook to support life sciences firms and universities sharing knowledge safely. (this comes from work begun by the Office for Life Sciences)
  • Summer 2011 – the government will update the UK’s Intellectual Property Crime Strategy (this comes from work begun by the Office for Life Sciences)
  • Autumn 2011 – Government will work with the National Information Governance Board and partners to public plans for a secure data service
  • Autumn 2011 – The NIHR will require providers of NHS services to meet certain benchmarks on timely and professional delivery of clinical trials if they want NIHR funding.
  • Autumn 2011 – the government will publish recommendations on how UK patent legislation can be improved so industry won’t be put off from funding clinical trials in the UK for fear of infringing patents. (this comes from work begun by the Office for Life Sciences)
  • Autumn 2011 – The government will produce country-specific workplans to support businesses to exploit their intellectual property in overseas markets ( this comes from work begun by the Office for Life Sciences).
  • November 2011 – The NHS Chief Executive will provide a report on how the adoption and diffusion of innovations can be accelerated across the  NHS
  • 2012 – the Clinical Trials Gateway will be in action
  • 2013 – Providers of NHS services will be measured on their performance at meeting certain benchmarks on timely and professional delivery of clinical trials and this will effect the funding they can get.
  • No deadline – the NIHR website will get a single, easy to navigate portal for information about clinical trials up and running on their website
  • No deadline – Government will look to publish prescribing data at practice level – an evaluation will be conducted by the NHS information centre first
  • No deadline – the government will launch a competition to set up a Cell Therapy Technology and Innovation Centre
  • No deadline – The government will put in place a whole lot of measures to make it easier for small firms to access the NHS.
  • No deadline – the government will put in place a package of measures to improve the take up of assisted living technology (part of the Office for Life Sciences work)
  • No deadline – the government will tidy up regulations currently restricting the social care market(part of the Office for Life Sciences work)
  • No deadline – the government will set up NHS Global separate to the Department of Health which will represent the NHS on a global stage and work entrepreneurially with international customers.

What next?

Government plans to continue reviewing this growth strategy throughout the rest of this Parliament to make sure it is working and guide their future action.

And we’re going to be following their progress on these planned deadlines, working with them where we can including feeding into revision of the EU Clinical Trials Directive and ensuring research is built into the centre of the new-look NHS as the Health & Social Care bill goes through parliament and keeping up the momentum for these reforms.

Posted in: Policy