A streamlined regulatory regime aimed at speeding up the arrival in Hong Kong of medicines for serious diseases will be extended to cover all new drugs from November 1, the government said on Friday. Under the “1+” mechanism, a new drug can be registered in the SAR if just one reference regulatory authority in the world has approved it, rather than two in the past. The mechanism was introduced last November for new drugs to treat life-threatening or severely debilitating diseases, and five products have been approved under it so far. The Department of Health said extending the relaxed regime to all new medicines will bring more choice for patients and strengthen the city’s ability to evaluate drugs. Alex Lam, chairman of concern group Hong Kong's Patients’ Voices, said Hongkongers will benefit from lower prices and a larger variety of drugs on the market. But he cautioned that quality may be undermined. "Previously we had two regulatory authorities’ approval, now we only need one. If that one authority comes from a country where the standing is not too high in the world, the quality may be lower and the risk to patients may be higher than before," he said. Lam said the World Health Organisation has stated which countries have higher standards regarding drug regulation, with most of them in Europe. In Asia, only Singapore and South Korea make it onto the list, he said. "When we expect more drugs coming from countries that are not listed as the highest standard, there may be a compensation of cost in terms of quality and risk associated with this kind of medicine. We have to be careful when we use it on patients in Hong Kong," he said. Lam added that the government needs to act as a gatekeeper to ensure patient safety, suggesting public hospitals should monitor the outcomes when patients are prescribed drugs approved under the mechanism, to check for any problems.
