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European Patient Safety and Parallel Pharmaceutical Trade - A Potential Public Health Disaster?
European Alliance for Access to Safe Medicines, Nov 2007, Pages: 100
Dr Jonathan Harper’s report provides a critical examination of European Patient Safety and Parallel Pharmaceutical Trade (PPT) in the European Union (EU)/European Economic Area (EEA). To date, the main academic and policy arguments have focused on the economic issues of PPT, but the report provides analysis of the topic in a broader context, which involves a number of factors in addition to pure health economics.
The factors examined include:
- the context of PPT in terms of contributing towards the achievement of the ‘single European pharmaceutical market’
- the concept of ‘artificial partitioning of the market’ with respect to European pharmaceutical trade, pharmaceutical purchasing and pharmaceutical consumption
- the drivers of PPT that relate to EU healthcare subsidiarity, the national differences in European pricing and reimbursement systems and the economic incentives employed
- the impact of the forthcoming new Member State derogation closure on overall EU PPT
- counterfeit medicines and European pharmaceutical supply chain security
- the legal and regulatory situation applicable to PPT in terms of weaknesses and costs
- the options open to the research-based pharmaceutical industry to circumvent PPT
- the issues of medicines safety, ultimate patient safety and health consumer choice
- the level of information available to stakeholders to enable informed opinion.
Report conclusions:
The European pharmaceutical market can be said to be suffering from the ‘Potential Public Health Disaster’ syndrome of ‘invisibility, biohazard and system failure’, particularly with respect to distribution chain regulation and supply chain security. The EU has undergone a lot of recent stress as a result of its enlargement process which impacts on the way the European pharmaceutical market works. The EU has made some progress in attaining its objective of achieving a single European pharmaceutical market in certain areas, but there are still many pre-existing and emerging challenges to confront.
These include the need to:
- rationalise the divergence and inefficiencies in the European pharmaceutical pricing and reimbursement system
- effectively manage European pharmaceutical supply chain complexity and security with adequate attention to both the human and technological elements
- have better European stakeholder coordination on drug safety
- have better medicinal product safety reporting systems that motivate and allow full participation of all stakeholders
- introduce some meaningful concepts and definitions concerning drug safety that all stakeholders can understand simultaneously, particularly the patient (or healthcare consumer).
From an examination of the areas covered by this report, it is possible to construct a calculus on the benefit or otherwise of PPT to the patient. Although some key areas of evidence are missing, a summary of the available evidence suggests that the practice of European PPT does not ultimately benefit the patient.
Finally, in the context of ultimate patient safety, a number of recommendations can be made both in terms of general pharmaceutical market functioning which impacts on the issue of European PPT, as well as specific recommendations that address the problem of European PPT in the context of pharmaceutical supply chain security.
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