The Halpin Protocol
Last week we launched a consultation on the Halpin Protocol, a blueprint which I hope will result in changes to the current legislation and rules governing the way drugs for people with serious and life threatening conditions are developed and prescribed. Although I could not be at last week’s Parliamentary launch debate, I followed it closely on Twitter and have listened to a recording of the whole event. I want to thank all of those who participated and spoke so well of their perspective on a challenge that potentially affects so many different stakeholder communities.
I also want to thank those who expressed an interest in observing the event, in particular Alan Thomas from mid-Wales, an ambassador for people suffering with Ataxia and who made a staggering 10 hour round trip just to attend. He will hopefully be helping us take the campaign to the Welsh Government.
And last but not least, the media who have kept this subject in the public eye, including my local Gloucestershire press who have treated my story in a very dignified and sensitive way, and The Sunday Times, which has run a number of stories now on the campaign and similar challenges experienced by others who want earlier access to drugs that may improve quality of life.
As a result of last week’s debate, Empower: Access to Medicine was raised the following day in Parliament by George Freeman MP, the Government’s Life Sciences adviser, who has expressed significant support and, as a result, he and Geoffrey Clifton-Brown are meeting with Health Minister Norman Lamb in the coming weeks.
I am realistic enough to know that any change to the current regulatory environment in this area will likely be too late to have any significant impact on my condition. But this isn’t about me. This is about the next generation of patients who deserve the chance to choose how they fight their battles and the risks they are prepared to take, as long as those risks are taken in a controlled environment under the strict guidance of their physician. It’s the patients who know most about the conditions they are living with day in, day out. All clinical trials data should also be shared publicly as this is the only way we are going to speed up evidence-based research and innovation.
As you know, despite the limitations of this illness, I am committed to pushing forward this debate and to keep its momentum high. Signatures on the e-petition are now well over 1500 – there’s a long way to go but I feel I am now taking a lot of people on the journey with me.
The Halpin Protocol
Many people wish to assist in creating the conditions for the speed of drug and therapy innovation in rare diseases to accelerate. There is a sense that the joint effect of the regulation of Clinical Trials and the principles of legal liability that currently govern such Trials works against those interests and that a mechanism should be devised that provides a framework for patients suffering from certain life-threatening diseases to make their own informed choices about the risks of participation in Clinical Trials of unregistered drugs and therapies.
This will require the collaborative participation of patients, regulators, physicians and the developers of drugs and therapies.
Regulators will be required to approve a Schedule of Unmet Clinical Need where acceleration of drug and therapy innovation is particularly important, justifying the controlled relaxation of restrictions on participation in clinical trials of unregistered drugs and therapies for patients suffering from those life-threatening diseases.
Physicians will be required to certify that the Patient has an acute unmet clinical need and to supervise the administration of the drug or therapy during the Clinical Trials.
Patients will be required to give informed consent to their participation in the Clinical Trials and also to give informed consent to the required modification of their right to strict liability protection.
Developers will be required to undertake that the Clinical Trials will be conducted in a properly controlled environment, under medical supervision and that the results of the Clinical Trials will be fully published whatever the results.
The Halpin Protocol
1. Does the Patient suffer from a life-threatening illness to which there is currently no sufficient medical treatment?
2. Does the Patient give informed consent to the modification of his/her legal remedies against the Developer of the Drug and against those conducting the Clinical Trials?
3. Has the Developer undertaken that;
a. the Clinical Trials will be conducted in a properly controlled environment and under medical supervision; and
b. the results of the Clinical Trials will be published whatever the results.