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[e-drug] Research for DFID's good practice in the pharmaceutical industry


  • From: "Samia Saad" <samiasaad@gmail.com>
  • Date: Mon, 4 Aug 2008 15:47:48 +0100

E-DRUG: Research for DFID's good practice in the pharmaceutical industry
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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] 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] The paper also set out
complementary UK government commitments.

Since that date, there have been many developments in company and
government 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] and access to key medicines in particular
to antiretrovirals has expanded significantly. Initiatives have also been
taken to stimulate innovation such as the Advanced Market Commit-
ment[4] for pneumoccocal vaccines. Governments and companies have
worked together through public-private partnerships to develop new drugs
and vaccines needed 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 is 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:

- The impact of the framework on both the UK Government and
pharmaceutical companies;

- Its usefulness for companies and other stakeholders;

- Key outstanding issues;

- 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:

- 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;

- A review of the impact of the 2005 framework itself on UK Government
and industry policy and actions;

- 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):

- Gathering material relating to the performance of both government and
companies against these policies, noting in particular examples of good
practice;

- 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);

- Identification of key issues that need to be addressed by companies and
government in the light of current circumstances to promote better access
to 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 will
also consider the role of the generic industry and how good practice
principles might apply to its activities. The consultation will also include
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 documen-
ting 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
industry 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 in
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
key 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
their 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, email: emma.back1@hotmail.com

Samia Saad, email: samiasaad@gmail.com

------------------------------

[1] Now the Department for Business Enterprise and Regulatory Reform
(BERR)

[2]Increasing people's access to essential medicines in developing
countries: a framework for good practice in the pharmaceutical industry.
March 2005 www.dfid.gov.uk/Pubs/files/pharm-framework.pdf

[3] Pledges and Contributions to the Global Fund
www.theglobalfund.org/en/funds_raised/pledges/

[4] Advance market commitments for vaccines www.vaccineamc.org/

--
Samia Saad
Consultant Health and Pharmaceuticals Policy
UK Mobile: 0044 7789 432838
E-mail: samiasaad@gmail.com