For the U.S., it will be very important over the next few years to engage in high-level, broadly based dialogue with European leaders over the implementation of the E.U. Directive and the Council of Europe Recommendation. Discussions will have to be held with national governments and with intergovernmental organizations. Health data and health research must be addressed specifically; they simply cannot be dealt with in the same way as banking, credit, tax, education, transport, or criminal data.
In these discussions private-sector organizations involved with health research should participate fully. So should regulatory agencies that require international transfer of health data.
Focal issues regarding health research will be:
- Specifics in the implementation of the E.U. Directive by Member States, and pan-E.U. decisions taken by the E.U. Working Party, the Commission, and the European Parliament.
- Especially, the determination of "adequacy" of conditions for transfer of data from the E.U. to the U.S. and other countries outside the E.U.
- The adoption by Members of the Council of Europe of the "Recommendation on Protection of Medical Data" and its detailed implications for practice.
- Recognition of the special needs in health research (such as the need to take ethnic and sexual factors into account, the need to accommodate secondary studies in databases, the need to retain data for a long time, and the like).
- Recognition of the special requirements already established in government regulation of research, development, and postmarketing study of pharmaceuticals, biological products, diagnostics, and medical devices.
- Recognition of the need to harmonize with the forthcoming E.U. Clinical Practice Guidelines (now in draft) and other international research guidelines.
- Emphasis on the need for uniform criteria and standards that will foster the international flow of health data.
In all of this, the U.S. government and other American organizations should not only be asking for concessions and exemptions, but also taking the opportunity of this period of reform to improve the ways they themselves handle these matters, and exerting international leadership.