Opinions Mixed on Hong Kong Regulatory Changes

While regulatory standards in Hong Kong's pharmaceuticals sector are notably higher than in many nearby markets, ethical drug producers continue to cite serious failings. Problems are especially acute in terms of the enforcement of intellectual property legislation, the lack of registration necessary for products destined for re-export to China's mainland, and the weaknesses in approval mechanisms for generics.

Ethical drugmakers' association HKAPI has recently lobbied the government to require companies to prove patent or licensing rights at the time of product registration. Under HKAPI's proposals, generic drug companies would also be expected to notify patent holders of their intent to register the drugs for local distribution. Copy drugs currently cost HKAPI members roughly 5% of annual sales.

Government plans to speed up generic drug approvals in Hong Kong have also attracted scrutiny. Changes to registration practices will mean that drug registrations will be accepted if the product has been approved in one other country. However, approval will not be given under the new scheme unless a third country has approved the product. To take one line of analysis on the plans, registration with China's notoriously inadequate drug and patent authorities would -- in theory at least -- be only a basic prerequisite for drug registration in Hong Kong, rather than assuring full approval.

Further concerns highlighted in a recent HKAPI report also include new restrictions on promotional material in the new so-called Undesirable Medical Advertisements Ordinance. On the other hand, pharmaceutical firms have welcomed other measures to ease prescription-to-OTC switches and improve protection of clinical trial data. Despite the positive signs, however, there will be fears that priorities set on the mainland are beginning to negatively influence local regulation.