WATCH COUNTRY

Oman

Intellectual Property Protection

There is no legal protection for pharmaceutical product patents in Oman. More than three ago, U.S. Embassy officials in Muscat asked Omani government officials to implement a patent law offering adequate and effective patent protection to pharmaceuticals. As of this writing, there is still no tangible progress, despite several encouraging official statements to the press.

The initial response to the 1996 U.S. Embassy initiative seemed positive. Within several weeks, the Ministry of Health issued a circular to multinational companies requesting patent data for products still under valid international patent. MOH officials explained to several research company representatives that the Ministry intended to establish a data base as a means of detecting and screening unauthorized copies. Most companies complied immediately with the request.

There also followed articles in the newspapers where officials were quoted announcing that almost 900 generic products, including many unauthorized (pirate) copies, would be de-registered in coming months.

Regrettably, despite this promising beginning and the "Special 301 Watch" listing of Oman since 1996, there is little tangible evidence that the Ministry of Health has carried through with these initiatives, and there is nothing to suggest that the Government has embarked on a meaningful effort to effect a patent law. In the meantime, dozens of unauthorized copies of top selling medicines continue 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 U.S. company revealed pirate versions of its patented products in several downtown Muscat pharmacies.

Also of concern, multinationals have received solicitations to participate in manufacture at a newly established local production company. Under normal circumstances, this would be a routine business consideration, however, in the absence of adequate and effective patent protection, the establishment of a new generic production facility is worrisome.

Other Trade Barriers

U.S. research based companies have become increasingly concerned about the transparency of MOH procedures that appear to unfairly favor competitors and regulations that unnecessarily retard the introduction of pharmaceutical innovations. In particular:

• 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 "pharmacovigilance" requirement that a pharmaceutical product be on the market for up to 2 years in the country of origin, despite the fact that U.S. companies submit extensive FDA-approved scientific and medical data substantiating product safety and efficacy; and,

• Requirements that unfairly favor the registration of products from GCC and Arab pharmaceutical companies, whereby international and U.S. 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 independent bioequivalence testing.

Potential Exports/Foreign Sales

PhRMA estimates current U.S. losses in Oman to be in the range of US $15-20 million dollars.

For all the aforementioned reasons, PhRMA believes that Oman should be listed as a Watch Country under Special 301 in 1999.