Intellectual Property Protection
There is no legal protection for pharmaceutical product patents in Oman. At the end of 1999, there is still publicly available information concerning Omani plans to provide appropriate patent protection, despite several encouraging official statements to the press. We hope that Oman will provide patent protection in connection with the planned implementation of a new GCC patent law and Oman's declared intention to complete WTO accession early in 2000.
In the meantime, Oman continues to allow unauthorized copies of top selling medicines to circulate in the private market, and pirate companies continue to tender bids for unauthorized copies in the larger public sector. As an example, an informal survey by one US company revealed pirate versions of its patented products in several downtown Muscat pharmacies. Moreover, Oman joined other GCC states in February of 1999, to support GCC ministerial Resolution No. 11, calling for a 5-year delay in patent protection for pharmaceuticals. This would delay patent protection until at least 2005.
Other Trade Barriers
US research based companies have become increasingly concerned about the transparency of MOH regulatory procedures that appear to unfairly favor competitors. There are also regulations that unnecessarily retard the introduction of pharmaceutical innovations. In particular:
Reports of conflict of interest whereby certain companies with family ties to MOH officials appear to have benefited from accelerated product review and registration;
Public procurement policies that favor manufacturers from Gulf Cooperation Council (GCC) countries, by allowing them to add up to 15-20% to bid prices for Government business vs. non-GCC suppliers;
A requirement that a pharmaceutical product be on the market for up to 2 years in the country of origin, despite the fact that US companies submit extensive FDA-approved scientific and medical data substantiating product safety and efficacy;
Requirements that unfairly favor the registration of products from GCC and Arab pharmaceutical companies. International and US research based companies are obligated to submit scientific data referring to extensive clinical trials and quality analysis in "major" or "primary reference" countries (e.g., the FDA in the USA or the EMEA in Europe or the MCA in the United Kingdom etc.). By comparison, regional producers obtain registration approval by meeting the minimum threshold for clinical evidence, without "major" or "reference" country approval, and in many cases, without submitting independent bioequivalence testing.
Research based companies are also concerned that no provisions are in place to safeguard data, as per WTO "data exclusivity" requirements.
Potential Exports/Foreign Sales
PhRMA estimates current US losses in Oman to be in the range of US $15- million to US$ 20 million dollars. As a pre-condition to joining the WTO, Oman should ensure that it provides patent protection at least at the WTO TRIPS level, and should also provide "pipeline" protection for new products, and data exclusivity safeguards. Also, a serious review of unnecessary pharmacovigilance rules and transparency issues in the MoH should be undertaken. The current system presents too many unnecessary hurdles to the introduction of new, innovative and high quality American medicines.