E-DRUG: Response on draft Eudra Vigilance Access Policy for medicines for human use
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This response has been prepared by Health Action International (HAI)
Europe. HAI Europe is a non-profit, growing, European network of
consumers, public interest NGOs, health care providers, academics, media
and individuals with over 25 years experience in representing the voice
of civil society, and poor and marginalised people in medicines policy
debates.
Response Summary
Health Action International Europe (HAI Europe) welcomes the EMEA's
decision to hold a consultation on the draft Eudra Vigilance Access
Policy for medicines for human use.
Giving stakeholders access to Adverse Drug Reaction (ADR) data is an
important step. However, 'access' is not the end of the story and it is
vital that the process of retrieval and format of information is
suitable for those who wish to use the data. As it stands, there is no
evidence that the EMEA or any other part of the EU has asked
stakeholders, in particular health professionals, patients and consumers
how they wish to use this information.
Main principles - What we need to know
The information should address the quality as well as the quantity of
data. Some of the most common questions that are likely to be asked
about a medicine are:
* What adverse effects might the medicine cause?
* How are they caused and how might they be prevented or
mitigated?
* What is the severity, duration, reversibility etc. of those
effects?
* In what circumstances do they occur?
* What might be the consequences for patients?
At a minimum, the ADR data provided by the EMEA should be capable of
responding to these issues. Simply offering access to tabulations of
suspected but unverified ADR reports will do little to help anyone
answer such questions.
Analysis, not just Access
People need to understand the reactions, and this requires clear and
detailed descriptions - at least the free text of the reports - not just
the use of standardised technical Medical Dictionary for Regulatory
Activities (MedDRA) terms, which were developed for quite a different
purpose.
Regrettably, the EMEA has not shown much interest in analysing the
adverse effects and it has not contributed to their investigation. A
detailed description and analysis of individual reports should be
available to facilitate investigation and the EMEA should play the
leading role in facilitating this.
The role of regulation
Elaborate regulation of access to largely unhelpful or useless data
misses the point and in no way satisfies the aims of openness,
transparency and accountability. The concern surrounding personal data
protection is understandable from a legal perspective but does not
inherently interfere with the provision of ADR data. It is possible to
achieve a balance between data protection and providing useful and
transparent data on adverse drug reactions. Most people who suffer an
ADR want others to benefit by helping to prevent similar events.
Lawsuits against clinicians, pharmaceutical companies, or the state
could be precluded with a disclaimer that "Eudravigilance data cannot be
used as the basis of litigation."
A lack of comprehensive data
It is unacceptable that access to safety data generated in
interventional and non-interventional trials will not be available to
healthcare professionals and the general public. HAI strongly opposes
this provision as it further entrenches the idea that it is acceptable
to withhold certain data generated in clinical trials. This data is
vital for interpreting safety issues that occur once a medicine is on
the market. We request that the EMEA reconsider the inclusion of this
provision.
Facilitating access
It is not clear from the text whether the database will be searchable
but it is important that there are a variety of criteria to retrieve the
data. Search criteria for the database should include: sex, age, product
(brand and generic names), type of reaction, date reported. The database
should also be constructed to enable searches on more than one
criterion, e.g. age and type of reaction.
Concrete proposals
* The database and format of information should be devised with
the needs of stakeholders in mind.
* The EMEA should take the lead in providing clear and detailed
descriptions of the reports.
* A disclaimer on the database would prevent restrictions on
access due to fears about lawsuits.
* All safety data generated in interventional and
non-interventional trials should also be made available to healthcare
professionals and the general public.
* All information in the database should be easy to retrieve
using a variety of search criteria in isolation and/or combination.
Terri Beswick
Communications Officer
Health Action International
Overtoom 60/II
1054 HK Amsterdam
The Netherlands
Tel: +31 20 489 1077
Fax: +31 20685 5002
Email: terri@haiweb.org <mailto:tim@haiweb.org>
Website: http://www.haiweb.org/>
Health Action International (HAI) is an independent, global network
working to increase access to essential medicines and improve their
rational use through research excellence and evidence-based advocacy.