The genomic revolution: is the real risk under-investment rather than bankrupt health care systems?

There is an element of 'scientific determinism' in much of the discussion of the genomic revolution. Recognition of the potential for improving health is more than matched by worries about both the ability of health care systems to cope and the potential for genetic testing to lead to discrimination. There are five main uses for genomics in the development of human diagnostics and therapeutics: pharmacogenomics, gene therapy, pharmacogenetics, genetic testing of symptomatic or at risk people, and population genotyping. Although there are potential health gains, several concerns exist: health gain may increase funding pressures on health care systems; providing cost-effectiveness thresholds may mean drugs for some patient groups may not be developed; random population genetic testing will meet economic and ethical obstacles; and private sector patenting risks a loss of data and access to data, which will inhibit the development of potentially cost-effective tests and therapies.

Is disease management relevant in Europe: some evidence from the United Kingdom.

Actions or approaches by the pharmaceutical industry, going under the general label 'disease management', have become very popular in the USA. However, there appears to be uncertainty about what exactly 'disease management' is and about the extent to which it can be applied in Europe. A postal questionnaire on disease management was sent out to senior personnel in the UK NHS and pharmaceutical industry. The survey aimed to explore the meaning of the term 'disease management' and its relevance to the NHS, assessing how perspectives differed between the two groups of respondents. Views on the barriers to the increase of disease management within the NHS were also sought. Finally, respondents were asked to indicate any involvement in joint disease management ventures. Most respondents agreed that disease management included estimating the total cost of managing a disease (92%) and the devising of clinical guidelines (97%). When asked about the particular role a pharmaceutical company might play, the level of agreement dropped in both groups of respondents, but by a greater degree in the NHS group. In defining disease management for themselves, just 4% of respondents referred to a 'partnership' between the NHS and the pharmaceutical industry. It would seem that, for the majority of respondents, 'joint ventures' are a possible, but not a necessary, means of undertaking disease management. Almost 30% of NHS respondents and 55% of industry respondents indicated that their Authority or company had experience of a joint venture in disease management. The major perceived barrier to an increase in disease management was NHS suspicion of pharmaceutical companies (86% of all respondents), with the difficulty in drawing up contracts coming a close second (79%).

Medical negligence and the NHS: an economic analysis.

Medical negligence was estimated to cost the NHS in England 235m pounds sterling in 1996/1997, growing at rate of up to 25% per annum. Yet analysis of NHS accounts suggest that a change in accounting policy has led to growth rates and recurrent expenditure on medical negligence being over estimated. The main concern, however, is total societal cost, not the accounting cost to the NHS. The objective of policy should be to ensure that cost-effective investment in injury prevention takes place. Measures that simply shift cost to other social budgets or onto patients are not helpful. NHS arrangements changed in the 1990s with Trusts taking responsibility for claims against hospital doctors and a new NHS Litigation Authority providing insurance for Trusts. It is unclear, however, whether Trusts have had either the incentives or the ability to implement effect risk management policies. Estimates based on two US studies and one UK study suggest that negligence in the NHS in England may cause around 90000 adverse events per year involving 13500 deaths, but only resulting in around 7000 claims and 2000 payments. A priority must be the establishment of a comprehensive national database of claims information. Other policy measures are proposed to reinforce the incentives on Trusts and doctors to implement cost-effective risk management policies.

The pros and cons of a single 'Euro-price' for drugs.

Parallel trade in pharmaceuticals has become a major European Union policy issue with several 'solutions' being considered by the European Commission, Member State governments and the pharmaceutical industry in the 'Bangemann Process'. This paper discusses the issues from an economic and public policy perspective--considering the economic cases for differential pricing and for 'Euro-prices', concluding that the economic case for parallel trade--to achieve convergence of prices--is not applicable to pharmaceuticals. It argues that health economic evaluation is not an appropriate tool to set 'Euro-prices' because of differences in clinical practice and in resource use and cost across countries. Pricing rules should reflect local willingness to pay for innovation. It concludes, however, that in the absence of policy changes there is a strong likelihood of companies refusing to supply new innovative products at low prices to traditionally 'low price' countries in order to avoid parallel trade undermining prices obtained elsewhere in Europe, with significant implications for the welfare of patients in those countries.

The UK pharmaceutical market. An overview.

The National Health Service (NHS) accounts for more than 98% of the UK prescription medicines market, which is the sixth largest pharmaceutical market in the world. Most of this market is driven by the UK's approximately 35,000 general practitioners (GPs). It is an open market, with most leading foreign pharmaceutical companies having a strong presence. While the growth rate of this market has been decelerating, it remains one of the fastest growing components of NHS expenditure. The NHS does not operate any kind of national reimbursement list, but the UK government has adopted several means to keep medicines expenditure under control. These include cash incentives and constraints for GPs relating to expenditure on medicines, individual quarterly updates on GP prescribing, the publication of a list of medicines that cannot be prescribed by GPs, the switching of some prescription-only medicines to over-the-counter medicines, and a co-payment system. The main form of economic regulation in the UK, however, remains the Pharmaceutical Price Regulation Scheme (PPRS). This limits the rate-of-return on capital attributable to medicines sales to the NHS, with the intended rate-of-return being equal to that of UK industry overall. The pharmaceutical industry has generally performed relatively well in the UK market, managing to preserve incentives to innovation. This reflects the fact that UK GPs have been able to maintain their clinical freedom, as well as government recognition of the economic contribution made by the pharmaceutical industry. Current issues of interest in the UK pharmaceutical market context include the future of the PPRS, the debates over the imposition of a national formulary and generic substitution, and over parallel trade, the potential impact of managed-care protocols and computer-based prescribing on pharmaceutical expenditures, and possible political changes.

Local reaction secondary to insulin injection. A potential role for latex antigens in insulin vials and syringes.

OBJECTIVE: To evaluate the possibility that latex antigens (natural rubber) can contribute to or cause local sensitivity at insulin injection sites. CASE: A subject with documented local cutaneous allergic reactions at the site of insulin injections and with systemic latex allergy manifested as anaphylaxis was tested with intradermal injections of insulin diluent from two manufacturers and with two brands of insulin syringes. RESULTS: The subject had high titer anti-latex Ige and elevated total levels of IgE in serum. Anti-insulin IgG and IgE antibodies were absent. Erythema and wheals occurred at the sites of intradermal injection of insulin therapy components (insulin diluent and syringes) that contain natural latex rubber but not at the site of injection of insulin therapy components that do not contain natural latex rubber. CONCLUSIONS: Small quantities of natural latex rubber antigens in insulin injection materials can be sufficient to produce local cutaneous reactions at the site of insulin injection in individuals highly allergic to natural latex rubber.

The pricing and reimbursement of pharmaceuticals.

This paper identifies common research themes arising from the papers on the pricing and reimbursement of pharmaceuticals presented elsewhere in this supplement. These include the following: How effective has cost containment been? What is the base case against which this is measured? Is there any evidence that research and development is changing in value or character as a result? How can the implied contract between government and industry be made more explicit to avoid opportunistic behaviour?