just released
https://www.hpra.ie/homepage/medici...vised&id=8db50726-9782-6eee-9b55-ff00008c97d0
.
report
https://www.hpra.ie/homepage/about-...annabis-for-medical-use---a-scientific-review
its a stepping stone atleast, some interesting stuff with a whole load of wtf , very different attitude compared with the near glowing sativex report.
https://www.hpra.ie/homepage/medici...vised&id=8db50726-9782-6eee-9b55-ff00008c97d0
Cannabis for Medical Use – Controlled Access Advised
News Category: Press release
Date: 10/02/2017
A report to examine the potential use of cannabis for medical purposes in Ireland was published today by the Minister for Health, Simon Harris. Cannabis for Medical Use – a Scientific Review makes eight recommendations and was compiled for the Minister by the HPRA, the state body that safeguards public health in relation to medicines. An expert working group*, convened by the HPRA, and chaired by Professor Tony O’Brien, Consultant Physician in Palliative Medicine, contributed to the review.
The report finds that the scientific evidence supporting the safe and effective use of cannabis products for medical treatment is insufficient and at times conflicting. Therefore, if a policy decision on access to cannabis for medicinal use is to be made, it advises that this must be controlled and confined to the treatment of specified medical conditions. The HPRA suggests this would be a significant first step that recognises patient need, whilst providing patient protection through medical consultant oversight. It recommends that access should only be undertaken within a legislative framework that provides for a central registry for collation of medical information and usage data to ensure accountability, and to inform the future direction of access to cannabis for medical purposes. The report states that cannabis has potential therapeutic benefits, but there is a need for robust evidence to be generated through clinical research in patients.
The Expert Working Group examined the relevant scientific reviews and publications available worldwide, as well as the international approaches to cannabis for medical use. It found that there are limited robust scientific data demonstrating the effectiveness (efficacy) of cannabis products. The safety of cannabis as a medical treatment is also not well characterised. For these reasons, and because most cannabis products available under international access schemes do not meet pharmaceutical quality standards, it is not possible to authorise such products as medicines. In this context, if access to cannabis products is to be permitted through policy change, the report advises that cannabis should only be available for the treatment of patients with specified medical conditions, which have not responded to other treatments, and where there is some evidence that cannabis may be effective. Such patients should also be under the direct supervision and monitoring of a medical consultant.
The specified medical conditions are:
Spasticity associated with multiple sclerosis;
Intractable nausea and vomiting associated with chemotherapy;
Severe, refractory (treatment-resistant) epilepsy.
The report indicates that there is insufficient clinical data to support the use of cannabis products in other medical conditions, at this time.
According to Dr Lorraine Nolan, Chief Executive of the HPRA, the outcome of the review confirms the many unknowns around the use of cannabis for medical purposes. It also highlights that the medicines’ regulations are not the barrier to cannabis access, as the main barrier is in fact the absence of sufficient scientific evidence-based information supporting cannabis as a treatment.
“To get to a point where we could authorise cannabis as a medicine, it must meet the same regulatory standards as that of every other medicine on the market. This is what the public expect and deserve. As we are not yet at that point, permitting access to cannabis for medical use is ultimately a societal and policy decision which has to balance the lack of scientific evidence against patient-led demand. As things currently stand, if cannabis products are to be made available through an access programme, it will be important that patients and healthcare professionals are aware of the limitations that will apply. The safety, quality and effectiveness of these products cannot be guaranteed or compared with the standards that apply for an authorised medicine,” said Dr Nolan.
Professor Tony O’Brien, Chairman of the expert working group, confirmed that based on the available evidence, the working group was pleased to cautiously advise for the restricted use of cannabis products for a limited number of medical conditions.
“Currently, the scientific evidence is insufficient to offer the public the necessary assurances in respect of the medical use of cannabis products across a wider range of possible conditions. This is something that will be kept under review. With regard to the specified medical conditions, the use of cannabis products would be initiated under expert medical supervision on a trial basis, in situations where patients have failed to respond satisfactorily to standard treatment regimes.”
Professor O’Brien highlighted that the primary function of the HPRA is to protect and enhance public health and explained that in assessing all health products, the HPRA must have due regard to the well-established authorisation process which is underpinned by scientific data.
Professor O’Brien thanked the Minister for initiating the review and expressed his appreciation to all of the national and international experts and agencies who contributed so generously to the expert group’s deliberations.
In conclusion, Dr Nolan said the HPRA recommendations provided for a “progressive first step that ensures safeguards are in place for individual patients and for society. It is an incremental approach that puts oversight and accountability at the heart of the process. It will also encourage research and facilitate the collection of information to determine the future medical needs for cannabis in Ireland.”
The HPRA states that there are a number of trials of cannabis-based medicines underway in Europe and worldwide and it will continue to monitor clinical evidence as it emerges. The HPRA welcomes the opportunity to work with stakeholders to support clinical research projects that can provide further insight into the therapeutic use of these products.
The HPRA will continue to report to the Minister in an advisory capacity on this matter, as required.
ENDS
FOR FURTHER INFORMATION:
Weber Shandwick PR (01) 679 8600
Siobhan Molloy / Rachel Galligan (086) 817 5066 / (087) 791 9901
NOTES TO EDITOR
Cannabis for Medical Use – a Scientific Review deals with the medical use of cannabis only. This is taken to mean a situation where a doctor prescribes or recommends the use of cannabis for treatment of a medical condition in a patient under his/her care. As the regulator of medicines, the HPRA has not been asked to consider the personal use of cannabis for medical or other purposes. Therefore, this matter is not addressed within this review.
*Working group members:
Professor Tony O’Brien, Consultant in Palliative Medicine (Chair)
Dr Colin Doherty, Consultant Neurologist & National Clinical Lead for the Epilepsy Programme
Dr Jennifer Westrup, Consultant Medical Oncologist
Ms Marie Wright, Palliative Care Pharmacist, Milford Care Centre
Dr Camillus Power, Consultant Anaesthetist, Pain Specialist
Professor Desmond Corrigan, Adjunct Associate Professor, School of Pharmacy & Pharmaceutical Sciences, TCD
Dr Bryan Lynch, Consultant Paediatric Neurologist, Temple Street Children's University Hospital
Dr Mike Scully, Consultant Psychiatrist, HSE Addictions Service , CHO 7 and Chair, Addictions
Faculty, College of Psychiatrists of Ireland
Aileen Tierney PhD, Patient Representative, Reg. FTAI , ICP, EAP
Joan Jordan, Patient Representative, EUPATI Graduate
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report
https://www.hpra.ie/homepage/about-...annabis-for-medical-use---a-scientific-review
EXECUTIVE SUMMARY
The Health Products Regulatory Authority (HPRA) convened an expert working group to assist
with its review of the potential medical use of cannabis, as requested by the Minister for
Health. The key findings of the working group are:
1. To date there is an absence of scientific data demonstrating the effectiveness (efficacy)
of cannabis products. The safety of cannabis as a medical treatment is not well
characterised. In particular, there is insufficient information on its safety during longterm
use for the treatment of chronic medical conditions, such as those for which there
is a public interest. For these reasons, and because most cannabis products available
under international access schemes do not meet pharmaceutical quality requirements,
they are not capable of being authorised as medicinal products (medicines). There
appears to be a significant gap between the public perception of effectiveness and
safety, and the regulatory requirement for scientific data which is mandatory to
determine the role of cannabis as a medicine. Any proposal to circumvent the
medicines regulatory system, established by law, would require careful consideration,
so as to avoid unintended consequences, and lower standards of patient protection.
2. The best outcome for patients is the development of authorised (or capable of being
authorised) cannabis-based medicines where the safety, efficacy and quality can be
assured, and understood by the patient and healthcare professionals.
3. A distinction can be drawn between cannabis products containing
tetrahydrocannabinol (THC) and those, such as certain cannabidiol (CBD) oils, which
contain no THC. The latter are not subject to the Misuse of Drugs legislation, and do
not contain the psychotogenic (capable of causing symptoms associated with
psychosis, including delusions, delirium and hallucinations) element of cannabis. As
such, products containing only CBD are not considered ‘controlled drugs’, and can be
provided under existing legislation. While the research is still limited, there are reports
that a CBD oil is capable of being authorised as a medicinal product and an application
for the first authorisation is expected in the USA and Europe in 2017.
4. The decision to permit access to cannabis for medical use is a societal and policy
decision due to the paucity of scientific research, the recreational use of the product
and the strong public and patient demand. If cannabis products that are not capable
of being authorised as medicines, are made available through an access programme,
patients and healthcare professionals must recognise the limitations of the programme
in assuring the safety, quality and effectiveness, as compared with what would be
expected for an authorised medicine.
5. If the policy decision is to make cannabis available for medical purposes, the HPRA
advises that it should recognise patient need, but be evidence based. Therefore, it is
Cannabis for Medical Use – A Scientific Review
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advised, that treatment with cannabis is only permitted under a controlled access
programme for the treatment of patients with;
a. Spasticity associated with multiple sclerosis resistant to all standard therapies and
interventions whilst under expert medical supervision;
b. Intractable nausea and vomiting associated with chemotherapy, despite the use of
standard anti-emetic regimes whilst under expert medical supervision;
c. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to
standard anticonvulsant medications whilst under expert medical supervision.
Patients accessing cannabis through the programme should be under the care of a
medical consultant and medical information and utilisation data should be kept on a
central register. This will ensure accountability and will inform the future direction of
access to cannabis for medical purposes. Clinical (patient) research should be
facilitated. Primary legislation will be required to address these points.
its a stepping stone atleast, some interesting stuff with a whole load of wtf , very different attitude compared with the near glowing sativex report.
