[Ip-health] 30 May 2011- HAI Europe Consultation Response on Health Threats

Press HAI Europe Press at haieurope.org
Wed Jun 1 02:48:54 PDT 2011


HAI EUROPE RESPONSE

 

 

 

Amsterdam, 30 May 2011

 

 

 

Stichting Health Action International Europe

 

Overtoom 60/II

 

1054HK Amsterdam

 

The Netherlands

 

Interest Representative Registration ID # 44361352681-84

 

 

 

This response has been prepared by Health Action International (HAI)
Europe. HAI Europe is a non-profit, 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.

 

Our authority rests on our integrity and independence from commercial
and political party interests, our research excellence and
evidence-based advocacy.

 

*        HAI advocates for access to essential treatments that satisfy
the priority health care needs of a population. 

 

*        HAI Europe promotes better access to medicines by advocating
for EU trade policies that are coherent with the EU's commitments on
health and development; by campaigning for changes to the EU's internal
market laws that hamper access to medicines in Europe; by advancing EU
actions on the exploration of new models of medical innovation.

 

*        HAI Europe is committed to ensuring the rational use of
medicines through greater controls on medicines promotion, independent
medicines information, greater patient involvement in the reporting of
adverse drug reactions so that harmful or ineffective medicines are
identified more quickly, thereby reducing the threat to public health.

 

*        HAI Europe advocates for the highest levels of transparency,
independence and accountability in all aspects of pharmaceutical policy
and regulation, as well as the wider participation of patients and
consumers in decisions that will affect their health and wellbeing.

 

 

 

Summary

 

Regardless of their origin, health threats are frequently tackled using
medicinal products. Medicines not only play a central role in treating
illness, but they can also be crucial to preventing the onset and spread
of disease. Therefore, any strategy to promote health security in the EU
needs to consider, among other things, how medicines can be used
rationally to achieve the best health outcomes and widest social
benefits.

 

As a civil society organisation committed to citizen-centred
pharmaceutical policies, Health Action International (HAI) Europe
supports the highest levels of transparency and accountability in
decisions that affect citizen health. We maintain that any strategy to
promote health security in the EU should be founded on: 

 

 

 

 

 

*        an objective assessment process of potential health threats;

 

*        the implementation of a policy to handle and resolve conflicts
of interest of those giving advice;

 

*        the appropriate evaluation of medicines intended for use in
health emergencies;

 

*        an inclusive and effective communication strategy;

 

*        ensuring that health security is compatible with civil
liberties;

 

*        developing measures to ensure the health security of vulnerable
population;

 

*        the transparency of decisions about health threats.

 

 

 

Objective assessment process

 

The identification and assessment of health threats in the EU needs to
be established through an objective process that is independent of
international health authorities. In the case of the H1N1 influenza, the
World Health Organization's (WHO's) official declaration of a pandemic,
issued shortly after an amendment to the definition of pandemic,
triggered a hasty response from EU governments. This resulted in the
unfortunate diversion of already limited public health resources on
medicines and vaccines. 

 

To ensure an appropriate response to health threats in Europe, HAI
Europe calls for the EU to reinforce the powers of the European Center
for Disease Prevention and Control (ECDC) as the public health authority
in Europe. As an expert European agency, it is best able to assess the
health threats and to advise on a calculated response suited to the EU
context. 

 

 

 

Establishing policies to handle and resolve conflicts of interest

 

Independence in scientific and expert advice is crucial to balanced
decision making. Conflicts of interest can bias regulatory affairs, and
compromised decisions could result in the market approval of medicines
of questionable efficacy or unproven safety, which would ultimately put
citizens at risk. 

 

Following the public declaration of an A/H1N1 Influenza pandemic in
2009, and the subsequent handling of the outbreak, important concerns
have been raised about the management and decision making surrounding
this 'pandemic'. Questions have arisen about the role played by the
pharmaceutical industry, particularly regarding whether commercial
interests had any influence on decisions made by EU Member States.[1] 

 

The European Parliamentary Committee on the Environment, Public Health
and Food Safety (ENVI) presented key recommendations to improve
cooperation, independence and transparency in their Report on the
evaluation of the management of H1N1 influenza in 2009-2010 in the EU.
In particular, the ENVI Committee has stated that: 

 

"The conflicts of interest among experts who advise European public
health authorities lead to suspicions of undue influence and harm the
overall credibility of these public health authorities and their
recommendations"[2]

 

The conclusions from this reflection on the EU's response to the H1N1
influenza should be applied to the wider context of health security. 

 

 

 

Health security at the EU level can be strengthened by ensuring the most
robust policy for handling advisors' conflicts of interest in relation
to decisions about medicines or other therapies intended for use in
health emergencies. To this end, HAI Europe supports the ENVI
Committee's call for EU public health authorities to develop:

 

"A European code of conduct relating to the exercise of the function of
a scientific expert in any European authority in charge of safety and of
the management and anticipation of risks"[3]

 

 

 

Specifically, HAI Europe supports a coordinated and comprehensive
approach to handling conflicts of interest by: 

 

-         Adopting a common definition of conflict of interest among
agencies, committees and other informal bodies advising on health
threats.[4]

 

-         Instituting the mandatory declaration of the details regarding
the activities of experts and decision makers in relation to any of the
following: employment, strategic advisory roles (gainful or not),
consultancy, representation (gainful or not), financial interests,
ownership of a patent or product, researcher, employment or involvement
at an institution receiving a grant or other funding.

 

-         Requiring that experts and advisors to EU authorities declare
their (potential) competing interests before taking up any duties.

 

-          Making participation in EU advisory groups and decision
making regarding health threats conditional on the full disclosure of
any potential competing interest. 

 

-         Mandating the EU authorities to publish all declaration of
interest forms.[5]

 

-         Creating a procedure to identify and resolve any competing
interest. In some cases, impartiality could be achieved by limiting the
advisor's involvement in the decision making process.[6] 

 

 

 

A conflict of interest can jeopardize the credibility of the decision
making body and the public trust afforded to its decisions. The rigorous
application of a policy for handling conflicts of interest can safeguard
EU decision-making from undue influence, ultimately supporting public
security and patient safety. 

 

 

 

Appropriate evaluation of medicines intended for use in health
emergencies

 

Regulatory agencies evaluate the safety, quality and efficacy of a
medicine. In health emergencies, regulators may feel additional pressure
to expedite the market approval of a medicinal product. HAI Europe
cautions against accelerated authorisation procedures for medicinal
products designed to respond to health crises. As medicinal products are
tested on a relatively small number of people before they are approved
for use by the wider population, previously undetected adverse reactions
can emerge. HAI Europe reinforces the overarching need to ensure the
correct assessment of the benefit-harm profile of a medicinal product
before authorising it to enter the European market. Part of correctly
assessing a medicinal product is ensuring that all of the clinical
information about safety and efficacy is publicly available.

 

Appropriate evaluation also includes the basis for making decisions
about stockpiling medicines in anticipation of a health emergency.
Stockpiling should only be undertaken for medicines that have a solid
basis of clinical evidence showing that they significantly impact the
disease that they are designed to treat. Where evidence is questionable
or unavailable, as was the case with Oseltamivir[7], limited public
health budgets and Member State resources should not be used to build up
supplies. 

 

 

 

Effective communication about health threats

 

Effective communication about health threats should provide timely,
accurate information in an accessible way. To this end, HAI Europe
recommends involving civil society organisations in decisions about the
appropriate format and dissemination channels for communicating risk and
harm information. By including the target audience in these preparatory
steps, EU authorities can enhance the readability and accessibility of
their messages and ultimately, raise public awareness of the health
threat in question through a variety of dissemination techniques so that
they are accessible to the widest possible European audience.

 

 

 

Ensuring that health security is compatible with civil liberties

 

During a health emergency it is important that measures taken to ensure
health security do not infringe on the rights of individuals, especially
those in vulnerable populations. As one example, guarding the health of
homeless people may lead authorities to take measures to put these
people into shelters even against their will. Mechanisms need to be
developed to guard against forcing people to undertake activities while
at the same time helping them protect their health.

 

 

 

Developing measures to ensure the health security of vulnerable
populations

 

Certain groups of people, for example the elderly, are especially at
risk during a health emergency for a variety of reasons. Any plan for
health security needs to ensure that the specific needs of these
populations are taken into consideration. 

 

 

 

Transparency of the EU's strategy for health security

 

An EU strategy for health security needs to ensure transparency at every
level of decision making. In particular, the rationale behind the
declaration of a health emergency and the authorisation of large-scale
medical interventions is crucial to the public understanding of how and
why these decisions are made within Europe. Given the significant public
resources involved, it is vital that European citizens have the
opportunity to scrutinize the decisions made on their behalf.

 

 

 

Link:
http://haieurope.org/wp-content/uploads/2011/06/30-May-2011-HAI-Europe-C
onsultation-Response-on-Health-Theats.pdf

 

 

 

For more information please contact:

 

Katrina Perehudoff: katrina at haieurope.org

 

***

 

 

 

 

 

 

 

 

 

Jasmin Blessing

Press & Communications

 

Health Action International (HAI) Europe

Overtoom 60/ II

 

 

 

 

 

 

1054 HK Amsterdam

The Netherlands

 

Email: press at haieurope.org

Tel: +31 20 683 3684

Fax: +31 20685 5002

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Web site: http://www.haieurope.org

 

HAI Europe staff blog about recent developments in medicines policy:
www.haieuropestaffblog.blogspot.com/

 

 

 

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.

 

 

 

Important Email Information:

 

The information contained in this email is confidential and may be
legally privileged.  It is intended solely for the addressee and is for
the exclusive use of the intended recipient(s). If you are not the
intended recipient(s), please note that any form of disclosure,
distribution, copying or use of this communication or the information in
it or in any attachments is strictly prohibited and may be unlawful. If
you are not the intended addressee, please contact the sender and
dispose of this e-mail immediately. Any opinions expressed are those of
the author, not of HAI.

 

 

 

 

 

 

 

 

 

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[1] Dr. Wolfgang Wodarg, medical expert specialising in epidemiology and
former Chair of the Sub-committee on Health of the Parliamentary
Assembly.  Statement presented to the Social, Health and Family Affairs
Committee of the Parliamentary Assembly of the Council of Europe in
Strasbourg on 26 January 2010. URL:
http://www.assembly.coe.int/CommitteeDocs/2010/20100126_Statement%20Woda
rg.pdf 

 

[2] Committee on the Environment, Public Health and Food Safety of the
European Parliament. Report on the evaluation of the management of H1N1
influence in 2009-2010 in the EU. (2010) Point 26. URL :
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPO
RT+A7-2011-0035+0+DOC+PDF+V0//EN 

 

[3] ENVI Report. Point 19

 

[4] ENVI Report. Point 27

 

[5] ENVI Report. Point 29

 

[6] ENVI Report. Point 20

 

[7] Doshi P. Neuraminidase inhibitors: the story behind the Cochrane
review. BMJ 2009;339:1348-51

 

Jasmin Blessing
Press & Communications
 
Health Action International (HAI) Europe
Overtoom 60/ II

1054 HK Amsterdam
The Netherlands
 
Email: press at haieurope.org
Tel: +31 20 683 3684
Fax: +31 20685 5002




Web site: http://www.haieurope.org <http://www.haieurope.org/> 
 

HAI Europe staff blog about recent developments in medicines policy:
www.haieuropestaffblog.blogspot.com/
<http://haieuropestaffblog.blogspot.com/> 

 

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.

 

Important Email Information:

The information contained in this email is confidential and may be
legally privileged.  It is intended solely for the addressee and is for
the exclusive use of the intended recipient(s). If you are not the
intended recipient(s), please note that any form of disclosure,
distribution, copying or use of this communication or the information in
it or in any attachments is strictly prohibited and may be unlawful. If
you are not the intended addressee, please contact the sender and
dispose of this e-mail immediately. Any opinions expressed are those of
the author, not of HAI.

 

 




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