Priority Medicines for the Citizens of Europe and the World” – comments from GlaxoSmithKline

The citizens of Europe should enjoy the highest levels of healthcare. We stand at a critical point in the pursuit of that goal, a point at which Europe and its MemberStates must decide on the strategic value of healthcare investment, innovation and competitiveness.

This Report, and this conference, therefore come at an important time. They make a significant contribution to the debate, and we welcome both.

The Report is constructive and pragmatic. It identifies areas for improvement, and acknowledges the responsibilities of all sides. The industry stands ready to meet its responsibilities. Indeed, GSK is actively engaged already in the vast majority of disease areas identified by the World Health Organisation, albeit at different levels of intensity. The recognition in the Report of the lead role of the pharmaceutical industry in addressing areas of unmet need is welcome.

We congratulate the authors for their identification and analysis of the barriers that affect the pharmaceutical research and development process. While the Report explicitly states that it does not address issues related to national healthcare systems, such as access to care and quality of care, it does highlight the unpredictability, delays and uncertainty inherent in reimbursement processes at national level. This recognition of the challenging environment within which the pharmaceutical industry operates in Europe is important. It reiterates the need to create a more balanced and sustainable environment, one that can reward innovation, manage costs, and deliver rapid patient access to optimal treatments.

We support the Report’s call for better dialogue and cooperation and endorse the statement that “regulators and governments should work with industry and others (including patients) to identify and remove, where possible, regulatory and reimbursement delays and barriers to innovation'. We agree with a number of the key points made, notably:

  • the need for increased involvement of patients in the regulatory process.
  • the need for better analytical tools and the recognition that the development of biomarkers for chronic diseases should be a public research priority.
  • the value of dialogue between regulators, national authorities and industry to review regulatory and reimbursement processes to ensure that requirements are effective and appropriate the recognition that new delivery mechanisms can constitute a priority area of unmet need.

The Report also looks at the issue of neglected diseases and diseases of the developing world. GSK is active in the research and development of vaccines and treatments for neglected diseases such as visceral leishmaniasis, malaria and TB. We support PPPs and incentives for research in this area and welcome the Report's mention of the Medicines for Malaria Venture, in which GSK has had a long-standing involvement. We have also, in partnership with the WHO, University of Liverpool, the London School of Hygiene and Tropical Medicine and the UK Government’s Department for International Development, developed the malaria treatment Lapdap.

The Report does include areas of concern. While we welcome the call for greater predictability in reimbursement, we do not believe this is best addressed through a single mechanistic price system, as outlined in the Report – we recognise, however, that the report stresses the need for further dialogue in this area, and would welcome the opportunity to participate. It will also be crucial that, going forward, activities within the Priority Medicines Project are based on consensus between the WHO, governments, the pharmaceutical industry and other stakeholders. The pharmaceutical industry’s research agenda should not be prescribed by any single body.

The pharmaceutical industry has made a major contribution to improved healthcare, in such areas as antibiotics, vaccination, anaesthetics, heart and asthma medication. And we stand on the threshold of major advances in healthcare. We are winning some of the major scientific battles – it is conceivable, for example, that the war on cancer can be substantially won by 2015 – and new technologies like genomics and pharmacogenetics will yield an era of more informed medical interventions with respect to prevention, detection, treatment and cure.

The key question therefore is how we build upon the WHO Report and realise the industry’s contribution. There are some key enabling factors, many of which are identified by the Report. Three areas are of particular importance - dialogue; regulatory efficiency; and a focus on value.

Dialogue

We need on-going high quality discussion between the pharmaceutical industry, governments and other bodies, such as the WHO. The contents of the Report demonstrate the importance and benefit of dialogue. The consultation process has been excellent and we congratulate the WHO and the Dutch Government on their efforts to secure input from a variety of stakeholders.

Such dialogue occurs too rarely. The benefits are clear and we need more. Industry and governments should be talking about health priorities for the next 10-20 years. This will deliver a strategic agenda for health and for the development of new medicines, ensuring that unmet need is addressed, disease prioritisation is clear, and patients get access to the medicines that will improve their lives.

The Report mentions initiatives such as the G10 and the importance of maintaining the competitiveness of the pharmaceutical industry in Europe. We must build a platform for the industry to lead progress towards Europe’s goals on competitiveness, innovation and research and development.

Regulatory Efficiency

Following the finalisation of the new EU pharmaceutical legislation and the completion of Enlargement, we are now at an important point in the development of the EU regulatory system. The use of new technologies in pharmaceutical R&D and the increased integration of pharmacogenomics and genetics in innovative medicines herald a new age in pharmaceutical innovation. To realise the full benefits, bottlenecks in drug development must be addressed by both the industry and regulators.

Focus on value

We recognise the challenges faced by healthcare systems in Europe and elsewhere as a result of aging populations and pressure on budgets. But too many parties seem to perceive innovation as a threat. As governments face expanding healthcare costs, they are opting for short-term policies. We need to move from a procurement to an investment mindset.

National healthcare systems must deliver fair and appropriate reward to industry for innovation and for therapeutic progress, in terms of efficacy, dosing improvements or other benefits. Governments should ensure that existing treatments in priority areas such as diabetes or asthma are made available to patients.

Where health technology assessment is undertaken, this should be done through appropriate mechanisms, conducted at the right time, in a transparent and scientifically robust way, with the goal of better healthcare, not rationing or delay.

The launch of this important report coincides with efforts by the EU to re-energise the Lisbon agenda for a competitive knowledge-based economy in Europe. Together, they may reflect a shift in mood, a sign that the key players are recognising that a new equilibrium is required if healthcare standards are to be optimised and the promises of innovation delivered. Achieving these goals will be challenging, but the benefits will be significant.

10 November 2004

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