Empower: Access to Medicine debate minutes
Empower: Access to Medicine debate - 12 September 2012 - The King’s Fund, London
Chair: Lois Rogers - Healthcare Journalist - The Sunday Times
Panellist: Dr. Richard Barker - Director of the Centre for the Advancement of Sustainable Medical Innovation - Oxford University
Panellist: Yogi Amin - Human rights and medical ethics lawyer - Irwin Mitchell
Panellist: Alastair Kent - Director - Genetic Alliance UK
Panellist: Professor Sir Peter Lachmann - Emeritus Professor of Immunology - University of Cambridge
Sara Lightowlers introduced herself as Les Halpin’s cousin and a consultant physician. Speaking on behalf of Les she briefly explained his involvement and motivation for launching Empower: Access to Medicine.
A summary video – introducing Les and the campaign - was played.
Chair Lois Rogers introduced the panellists.
Alastair Kent was first to speak. He talked about the patients he works with and the need to understand the patient and family perspective. He said that medicine is the one area where we are not trusted to make our own risk assessment, and stressed his belief that patients should be empowered in this respect. Patients should have a voice on the role of innovation licensing – not a veto but an equal vote in the process as other key stakeholders.
Richard Barker echoed Alastair’s sentiments. He said that major drug companies have been cutting back on their research budgets because the R&D process has hit a wall of cost and time – particularly apparent for those diseases that affect a very small population. There is no one culprit, all stakeholders must work together. We must rethink regulation. Exponential growth in understanding of disease has not been reflected in practical application because we first need to tackle ethical, economic, statistical, and governance problems.
Sir Peter Lachmann said that a campaign such as Empower: Access to Medicine is the most effective way to get results. He said that the R&D process is so ruinous that only big pharma can produce new drugs, and then only for common drugs. Litigation against drug companies has also been hugely damaging. He argued that patients are not always best placed to decide on their medication. He also argued that phase III trials are of limited use. He said that patients should be free to adopt tested drugs if they waive litigation for statistical side-effects. More investment in the NHS is needed to cope with statistical side-effects.
Yogi Amin said that the law is a vehicle of social justice and that strict liability should be replaced with the tort of negligence, as this reflects greater freedom for the patient. There will have to be many high-profile legal cases in which patients have been denied access to medical trials before the system will change. He said that if the evidence is presented in the right way, judges will accept that strict liability should not always apply, and that the legal framework will change as a result.
Lois Rogers summarised the opening remarks.
Geoffrey Clifton-Brown MP outlined his involvement and support for the campaign. He said that he had already had a number of meetings with Les Halpin over the past three months. He outlined the meeting that he facilitated between Les and Earl Howe – the Health Minister responsible. Geoffrey said that the campaign needs to be driven jointly by medical experts and politicians, who need to pressure the Government for change. He said he will apply for a debate on the subject in the House of Commons which will generate further momentum, and that this grass roots campaign will develop into a meaningful legacy for Les.
Damian Crowe, a friend and business partner of Les Halpin, asked what the practicalities of changing the law might be. Geoffrey Clifton-Brown answered that he was confident of getting a debate in Parliament, and with the right publicity the public would pick up on it – the government will listen to a large number of people demanding change. Alastair Kent added that regulators, whose role is conservative by nature, needed to be persuaded to change their attitude: they should be asking “what are the costs associated with not allowing this to happen?”
Dr Richard Barker made the point that conservatism is also bred into pharmaceutical companies. He endorsed Peter Lachmann’s model which he termed ‘adaptive licensing’. There should be different regulation for mass and orphan drugs. The European Medicines Agency has an objective to pilot a new system of this type, called progressive authorisation:
“We [the Centre for Accelerating Medical Innovations] are in the process of working with companies to try and find pilots which will effectively do what Peter is calling for.”
In these pilots patients would be free to take the drugs after phase II testing.
Peter Lachmann spoke about the ill-thought-out nature of drug regulation, which is almost unique - a consumer product with strict liability. He said that regulators would like to see the law changed, but:
“they have to enforce the regulations and the laws as they stand… It is not entirely a case of the lunatics put in charge of the asylum.”
The chair then asked if anyone had direct experience of patients being denied access to trials, and after a show of hands said “quite a few”. Anne-Marie Irwin of Irwin Mitchell said that she had acted on behalf of a child who had to go to the US to get treatment.
Sir Peter Lachmann explained that, providing they can get hold of it, a drug can be administered by a reputable physician for compassionate (non-trial) use under named-patient exemption. The limitations come from the manufacturers who are reluctant to make available unlicensed drugs which they are looking to license - in case of damage to the drug’s eventual approval.
Rea Mattocks of the Birdshot Uveitis Society said that she was turned down a recommended drug because it was not licenced for her disease – “nothing is licenced for my disease”. She appealed against the decision and two years later she got the medication, but not in time to save her sight. She stressed the time-critical nature of this and also argued that, because most of these diseases are genetic, they are more than willing to be guinea-pigs for the sake of their children.
Alastair Kent said it is unfair to make the patients responsible for changing the system in addition to dealing with their illness.
Wen Hwa Lee of Oxford University called for greater public education on the drug approval process.
Holly Peterson of the University of Exeter raised the issue of how do you help doctors – in the case of rare diseases -understand how to advocate for the patient? Lois Rogers outlined a DoH consultation that is attempting to address this deficit, but she expressed her lack of optimism at the effectiveness. Alastair Kent and Peter Lachmann commended research charities for their work in this area. Richard Barker made the point that all diseases are getting rarer- as medical understanding grows “we have a problem of burgeoning diseases”.
Geoffrey Clifton-Brown MP then spoke of a “post-code lottery” among hospital trusts, and provided the example of Gloucester PCT which receives less funding “than some inner city trusts which have a big allowance for deprivation”. It is vital to ensure that patients dependent on rare drugs are not affected by this.
Lynda Wight of Topra introduced EUPATI, an initiative to educate patients on the drug development process. Alastair Kent added that EUPATI should improve the patient voice.
Jenni Thorburn of the AKU Society suggested that there should be better education on rare diseases for doctors early on down the line. She added that PCTs are refusing to pay for rare-drug trials. Peter Lachmann said that the NHS nowadays is run by financing. Yogi Amin said that “without funding a trial can be challenged”. Alastair Kent outlined the issue that, because of the disparate spread of rare diseases, governance approval for trials is especially costly and hard to organise: the NHS has “a stated ambition to move in one direction and a legal framework pushing in the opposite direction”. Richard Barker said that Empower; Access to Medicine should push for a more proactive role in research for the NHS.
The chair summarised the discussion and emphasised the need for the campaign to focus on a two-pronged parliamentary and public approach. She thanked everyone for coming and directed people to the campaign website www.accesstomedicine.co.uk to keep up to date with latest developments.