[Ip-health] RESEARCH FOR DFID's GOOD PRACTICE IN THE PHARMACEUTICAL INDUSTRY
Samia Saad
samiasaad@gmail.com
Wed Aug 6 11:22:21 2008
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[ Picked text/plain from multipart/alternative ]
RESEARCH FOR A Background paper ON
good practice in the pharmaceutical industry
AND UK GOVERNMENT POLICIES ON ACCESS TO MEDICINES
Background
In 2005, the UK Department for International Development (DFID), the UK
Department of Health (DH) and the then UK Department of Trade and Industry,
[1] <#11b8e36720abeba6__ftn1> published a policy paper that set out a
framework to provide guidance to pharmaceutical companies on best practices
in increasing access to medicines in developing
countries.[2]<#11b8e36720abeba6__ftn2>The paper also set out
complementary UK government commitments.
Since that date, there have been many developments in company and governmen=
t
policies and, more generally, in the global environment for access. The UK
and other donor governments have substantially increased their commitments
to organisations such as the Global Fund to Fight AIDS, TB and
Malaria,[3]<#11b8e36720abeba6__ftn3>and access to key medicines =96 in
particular to antiretrovirals =96 has
expanded significantly. Initiatives have also been taken to stimulate
innovation such as the Advanced Market
Commitment[4]<#11b8e36720abeba6__ftn4>for pneumoccocal vaccines.
Governments and companies have worked together
through public-private partnerships to develop new drugs and vaccines neede=
d
in developing countries. Many companies have maintained or developed their
differential pricing offers for developing countries and some have licensed
their technologies more freely to developing country producers. But there i=
s
still much more that both governments and companies need to do to help
improve access to medicines.
Research and Consultation Objectives
The UK Government's 2005 framework suggested that the UK should report on
progress at a later date including in relation to:
=B7 The impact of the framework on both the UK Government and
pharmaceutical companies;
=B7 Its usefulness for companies and other stakeholders;
=B7 Key outstanding issues;
=B7 New areas of work.
To this end, DFID has contracted two consultants, Emma Back and Samia Saad,
to conduct research and collect data to include:
=B7 A thorough review of the practices and policies outlined in the 2005
framework relating to affordability, research and development, impact in
developing countries, and reporting and verification;
=B7 A review of the impact of the 2005 framework itself on UK Government =
and
industry policy and actions;
=B7 A review of the process for developing and implementing the 2005
framework and an assessment of this alongside those processes adopted for
other similar documents (for example those developed by industry investors,
Oxfam, the Access to Medicines Index and the UN Special Rapporteur on the
Right to Health):
=B7 Gathering material relating to the performance of both government and
companies against these policies, noting in particular examples of good
practice;
=B7 A consultation where necessary on future policies and plans with
industry representatives through an already established Industry Working
Group supported by the Association of British Pharmaceutical Industries
(ABPI);
=B7 Identification of key issues that need to be addressed by companies a=
nd
government in the light of current circumstances to promote better access t=
o
medicines, including through interviews with key informants in companies,
government and other stakeholders including civil society.
The focus of the research will be on the research-based industry but it wil=
l
also consider the role of the generic industry and how good practice
principles might apply to its activities. The consultation will also includ=
e
technical agencies such as the World Health Organization (WHO) and third
party providers and facilitators of access to medicines programmes where
relevant.
The purpose of the research is to produce a background paper documenting
developments since 2005 and assessing progress. The paper will form the
basis for a subsequent revision of the UK's 2005 Good Practice Framework.
Timelines
* *
1. Desk based research will be conducted in July and August 2008;
2. Consultation where necessary with industry, UK Government departments
and other relevant stakeholders will be conducted between 1-19 September
2008;
3. A draft research report will be circulated to industry and others in
early October 2008;
4. Further consultation to discuss the draft research report will be
conducted in mid-October 2008.
* *
*
*
Outputs
* *
Based on the reviews and consultations outlined above, a background report
will be produced to inform the subsequent edition of the UK's Good Practice
Framework, the development of which will be managed by DFID, in
collaboration with BERR, DH and the Intellectual Property Office (IPO).
The consultants' background report will set out the developments in industr=
y
and government since 2005 in relation to the aspirations and commitments
made in the 2005 UK Government paper and will contain:
1. Factual material on the policies pursued by industry and government i=
n
relation to research, pricing, patenting, licensing and other areas covered
in the 2005 framework;
2. A qualitative assessment of progress made since 2005, by industry and
government, in implementing policies on access to medicines, identifying ke=
y
areas where good progress has been made, and areas in which there is room
for improvement;
3. An assessment of the impact of the 2005 framework paper specifically
(and of the process employed to develop it and to track its implementation)
in stimulating such progress.
Comments
* *
Comments are invited from interested parties to aid the consultants in thei=
r
work. Such comments should be concise (no more than 2 pages) and highlight
particular issues that respondents believe the consultants should take into
account. Comments should be received by 22 August 2008.
Please address any comments to
Emma Back: emma.back1@hotmail.com
Samia Saad: samiasaad@gmail.com
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[1] <#11b8e36720abeba6__ftnref1> Now the Department for Business Enterprise
and Regulatory Reform (BERR)
[2] <#11b8e36720abeba6__ftnref2> *Increasing people's access to essential
medicines in developing countries: a framework for good practice in the
pharmaceutical industry*. March 2005
http://www.dfid.gov.uk/Pubs/files/pharm-framework.pdf
[3] <#11b8e36720abeba6__ftnref3> Pledges and Contributions to the Global
Fund http://www.theglobalfund.org/en/funds_raised/pledges/
[4] <#11b8e36720abeba6__ftnref4> Advance market commitments for vaccines
http://www.vaccineamc.org/
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Samia Saad
Consultant Health and Pharmaceuticals Policy
UK Mobile: 0044 7789 432838
E-mail: samiasaad@gmail.com