Intellectual Property Protection

PhRMA is concerned that the Hong Kong Department of Health recently approved 14 generic compounds which the research-based industry in Hong Kong believes infringes the patents of the originators, including Proton Pump and HMG CoAg Reductase Inhibitors. Some of these products, as we understand, were approved partly on the basis of information in the originator's regulatory dossier, which is allowed within certain limits through existing regulations of the Department of Health (DoH).

The research-based industry in Hong Kong is pressing for legislative amendments to close what we believe is an unacceptable loophole in this regard. PhRMA believes that the Hong Kong DoH should review the patent life of any product that comes up for approval in the Special Administrative Region (S.A.R.)of Hong Kong. The Hong Kong DoH should not approve products which infringe the patent of the originator of the product in Hong Kong, and should limit the use of the originator's dossier in seeking such approval.

PhRMA also is concerned that some pharmaceutical products, imported from various countries, including Malaysia, Indonesia and Greece, have not received official regulatory approval in Hong Kong. Although the imports are recorded upon entry, if they are officially designated for re-export (i.e., often to China), there is no requirement that they be approved in Hong Kong, or for the presentation of records on whether, and in what quantity, the shipments have left the S.A.R. This, we believe, has led to the diversion of substantial quantities of non-approved products to the local market in Hong Kong. This, in turn, has eroded the market exclusivity of the patented medicines of PhRMA member companies in Hong Kong.

Market Access Barriers to Patented Pharmaceutical Products

Regulatory Delays: PhRMA is concerned that new procedures for the approval of prescription drugs will delay access to innovative medicines from PhRMA member companies for patients in Hong Kong. Under recent changes in drug approval regulations, prescription product approvals, rather than marketing being allowed immediately after approval by the Pharmacy and Poisons Board, will not be granted until the forensic classification by the Legislative Council is cleared and officially gazetted The research-based industry in Hong Kong believes that the requirement could double approval times to eight months. PhRMA is concerned that further approval delays will shorten effective patent life, reduce returns on research investment and delay patient access to new therapies.

PhRMA is currently studying methodology for estimating damages caused by the aforementioned trade barriers in Hong Kong. It is not possible at this time to estimate the financial impact of the aforementioned barriers on the research-based pharmaceutical industry in Hong Kong.