Bahrain maintains a curious policy requiring that new pharmaceutical products be on the market for a minimum of 2 years as a condition for marketing authorization. The apparent objective of the regulation is to ensure adequate pharmacological efficacy and safety. The rule, however, far exceeds reasonable safeguards for US and international research-based pharmaceutical companies. US research based pharmaceutical companies must meet the stringent and extensive efficacy and safety requirements of the FDA and/or 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 at least two years is not supported by scientific or medical evidence. Although exceptions are frequently granted, the regulation represents an unnecessary regulatory impediment to technology transfer and the introduction of pharmaceutical innovations to Bahraini patients.
The pharmaceutical industry has been informed that Bahrain's patent laws have been amended recently to ensure TRIPS conformity. PhRMA member companies, however, have not been successful in attempts to obtain a copy of the law from the Government, and therefore, can not verify these claims. In a disturbing development, Bahrain joined other GCC member states in supporting GCC ministerial resolution No. 11, approved in February. Despite the fact that Bahrain has provided patent protection for pharmaceuticals since 1957, Resolution No. 11 calls on GCC states to implement a 5-year "grace" period for pharmaceuticals, delaying protection until 2005.
Finally, Bahrain maintains a policy of price controls on pharmaceuticals which reduces opportunities for market based competition among manufacturers, distributors, wholesalers and retail pharmacists.
Potential Exports/Foreign Sales
Removal of the 2 year rule for companies demonstrating product registration in "reference" countries, and implementation of a "fast track" system for the evaluation of cutting edge medicines, could lead to the earlier introduction of innovative American pharmaceuticals and enormous new benefits to patients. PhRMA urges the US government to reconfirm Bahrain's commitment to product patent protection and a clarification regarding Bahrain's support for GCC Resolution No. 11.