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• Advocacy on research practices

Corporate Responsibility Report 2008

Advocacy on research practices

We regularly engage with policy makers and other stakeholders on issues relating to research practices and the research environment. Read more about research practices.

Global activity

Advocacy on revisions to the Declaration of Helsinki

Organisations engaged: World Medical Association, American Medical Association

Industry associations involved: BIO, IFPMA, PhRMA

GSK position: The Declaration of Helsinki sets out the ethical principles for the conduct of research on human subjects. The Declaration was revised in 2008 by the World Medical Association. We urged the World Medical Association to resist changes that make the document more detailed and prescriptive, because we believe they create confusion and conflict with other, more detailed guidance such as ICH guidance on Good Clinical Practice.

Shaping the scope of the International Regime on Access and Benefit Sharing

Organisations engaged: Secretariat to the Convention on Biological Diversity (CBD), Ad Hoc Working Group on Access and Benefit Sharing, UK DEFRA, DG Trade (European Commission), national European governments, US government.

Industry associations involved: BIO, BPG, EFPIA, ICC, IFPMA, PhRMA

GSK position: The Convention on Biological Diversity (CBD) was signed in 1992. It has three main goals, including the fair and equitable sharing of benefits arising from the use of ‘genetic resources’. GSK believes that the best way to achieve the CBD’s access and benefit-sharing objectives is for countries to introduce national laws governing access to their genetic resources and for mutually agreed contracts to define how any benefits arising from their use should be shared. This approach allows national governments the flexibility to develop guidelines that will best serve their national interests, and enables users of the guidelines to reach agreements that are appropriate to each individual case.

Notwithstanding GSK’s support for national legislation we recognise the CBD’s mandate to ‘elaborate and negotiate an international regime on access and benefit-sharing’. We believe that the resulting regime, currently under discussion within the CBD, should be consistent with the CBD’s treaty and objectives. It should create no new obligations for CBD signatories and should not be applied retrospectively. It should provide guidance to governments and other CBD members on how to achieve access and benefit-sharing objectives, rather than prescribing rules. It should adopt a sectoral approach and not seek to enforce a ‘one size fits all’ solution on all industries. It should apply only to genetic resources as defined in the CBD, not a broader class of materials. It should not extend to human genetic resources, nor to derivatives, or pathogens.

Read our position statement on the Convention on Biological Diversity.

European activity

Advocacy on the European Animal Directive

Organisations engaged: European Commission

Industry associations involved: ABPI, EFPIA

GSK position: The European Animal Directive, originally introduced in 1986, governs the use of animals for experimental or other scientific purposes. It aims to establish a framework for all animal research activities within the EU. The European Commission has published a draft revision of the Directive which controls the use of laboratory animals and sets minimum standards for their housing and care.

GSK welcomes the review of the Directive and recognises the need for it to be revised to reflect advances in animal welfare and science. We welcome many of the recommendations in the draft revision, many of which are already integrated into our current practices. For example, we welcome the rules relating to the replacement, reduction and refinement in the use of animals in research (known as the 3Rs), and the need for a permanent or standing ethic review body in the establishments that use animals in research.

It is essential that any legislative changes achieve high animal welfare standards while supporting an environment that allows research that leads to new medicines and vaccines to meet patients’ needs. In this regard we have a number of concerns related to the restrictions on the use of non-human primates to those diseases that are considered life-threatening or seriously debilitating and the reuse of surgically instrumented animals which is likely to result in an increased number of animals where procedures are mild to moderate.

Read our position statement on use of non-human primates in research.

Supporting a new approach to pharmacovigilance in the EU

Organisations engaged: European Commission, European Medicines Agency, UK government

Industry associations involved: ABPI, EFPIA

GSK position: GSK seeks a new approach to pharmacovigilance regulation in the EU that will allow pharmaceutical companies and regulators to focus their resources on safety evaluation activities instead of compliance with unclear and complex regulatory demands.

New pharmacovigilance legislation should contain clear and concise provisions to simplify, strengthen and provide legal certainty to the EU legislative framework for pharmacovigilance. Specifically, it should:

• Contain a single set of simplified rules, and a single reporting point, for adverse drug reactions in the EU
• Require the reporting of all serious cases when an electronic reporting system is implemented
• Contain clear and flexible provisions that allow individual companies to appoint the number Qualified Persons for Pharmacovigilance (QPPVs) they require
• Provide consistent standards for inspections of company pharmacovigilance departments by EMEA and EU member state authorities

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