Bahrain

Intellectual Property Protection

Although Bahrain's legal system does provide for the protection of pharmaceutical products, the system is deficient because it requires a re-registration of patents filed in the United Kingdom. Some pharmaceutical inventions are not patented in the UK, and there have been instances where such patents have not been re-registered in Bahrain. A re-registration requirement also can make international licensing agreements more complicated, as the entity responsible for the product in Bahrain may not be the patent owner of record in the UK.

In a worrisome new development, a Jordanian company well known for pirating American pharmaceutical products has announced that it will participate in a joint production venture. Given the inadequacies of the current patent regime, a local production facility -- particularly if under the joint management of a Jordanian pirating company -- may target internationally patented products not covered under the existing law.

Other Trade Barriers

Bahrain follows a curious rule requiring new pharmaceutical products to be on the market in another country for a minimum of two years as a condition for registration approval and market introduction. This law, which appears to be aimed at ensuring adequate pharmacological efficacy and safety, far exceeds the requirements that U.S. and international research-based pharmaceutical companies must meet for registration in other countries. U.S. research-based companies must meet the exhaustive and extensive efficacy and safety requirements of the FDA and other "major" or "primary reference" countries, e.g. the Medicines Control Agency (MCA) in the United Kingdom, or the European Medicines Evaluation Agency (EMEA). The requirement that the medicine be on the market in those countries for two years before Bahrani approval is not supported by the scientific and medical evidence, and is an unnecessary impediment to technology transfer and the introduction of pharmaceutical innovation to Bahraini patients.

Potential Exports/Foreign Sales

Pharmaceutical piracy is not a major feature of the Bahrain market as yet, thus U.S. exports likely would not increase significantly as a result of legal changes. The threat of increased registration of pirated copies is a real one, however, and could result in significant losses to American companies, particularly in Government tenders. The unnecessary requirement that new products be on the market in the "country of origin" for two years, however, constitutes a trade barrier that also slows the introduction of new medical technology. While the requirement makes sense for products originating in countries without resources for comprehensive regulatory review, it is unnecessarily burdensome on U.S. research based companies offering superior quality and exhaustively tested and analyzed products.

Outlook

PhRMA concludes that pending changes to bring Bahrain's antiquated, UK-based patent law into compliance with GATT/TRIPs requirements, the risk of patent "gaps" persists for U.S. products. This issue is more sensitive now, as a financially pressed Ministry of Health appears to be searching for budgetary "short cuts," including the importation of unauthorized copies or generic copies that are of substandard quality.

PhRMA also notes that the "2 year rule" poses an unnecessary trade barrier on U.S. research based companies and products, and should be modified to account for the fact that PhRMA companies routinely submit data exceeding international efficacy and safety standards.