Experts say there is a need to simplify the drug approval procedure, which can take 18 to 24 months compared with 60 days in Singapore
EMILY TSANGemily.tsang@scmp.com
PUBLISHED : Monday, 31 August, 2015, 4:29am
UPDATED : Monday, 31 August, 2015, 9:08am
It can take around 18 to 24 months for Hong Kong authorities to recognise a new drug. Illustration: Henry Wong
Hong Kong's medical standards are considered to be among the best in the world. Yet, doctors and patients lament one problem that can only get worse - outdated drug regulation procedures.
Patients wait far longer to gain access to innovative medicine than those in many other medical hubs because the drug regulation regime here is still based on old, rigid protocols.
A University of Hong Kong thesis published in 2013 pointed out, for example, that it takes around 18 to 24 months for the local authorities to recognise a new drug - when the same medicine can be approved in just 60 days in Singapore.
Drug approval in Hong Kong is greatly dependent on whether a product has been given the go-ahead by international health authorities and advanced countries or regions such as the European Union (EU), and by the US Food and Drug Administration (FDA).
While experts suggested a more relaxed approval system is needed, they said the culture of relying heavily on the publicly funded health care system is also partly to blame as the government is under pressure to be costeffective in using taxpayers' money to fund new and expensive drugs.
They believed a voluntary health insurance scheme proposed by the government to correct the imbalance between demand for public and private hospital services would offer hope in correcting the inflexible pharmaceutical registration system.
"The local authority tends to approve a new drug only after both the EU and FDA give it the green light," said Dr Stephen Chan Lam, assistant professor of oncology at Chinese University.
Read more: Drug makers urged to share the cost of providing costly medicine in Hong Kong
"In other Asian places such as Singapore and Taiwan, the authorities only require either one of the two approvals from these watchdogs before they decide to give the green light to a new drug. Sometimes they will not bother to wait for international approval if they think the study is strong enough."
Chan said Hong Kong has a reputation for being slow and conservative in approving new drugs, often taking a few years, especially compared to other affluent Asian places.
"It is often the case that a new drug that we have been waiting for for years has long become standard medicine for people in those places," Chan said.
The slow and prolonged approval process could harm patients and increase the fatality rate due to the inaccessibility of more appropriate medicine. This has been particularly true for patients with rare diseases, for which medicine is often very expensive.
One such patient now suffering the consequences is Steve Chan, a 39-year-old who has a rare blood disease which afflicts around one in every million people. He cannot receive a new treatment for his condition as public hospitals are still waiting for approval for an expensive drug which is nevertheless available abroad.
The father of two faces a life-threatening situation every day as he is only receiving supportive care and frequent blood transfusions, which cannot cure him.
According to the Department of Health, there is a three-step procedure for a manufacturer to apply for approval for a new drug in the city. First, the application is evaluated by the department's Drug Office, which will proceed with the submission only after the product has obtained two certificates of pharmaceutical product from a selection of countries and regions such as Europe, the US and Japan.
The submission is then passed to a group of scientists under the Pharmacy and Poisons Board, which conducts just five meetings a year to consider the registration of new drugs. The board will then submit the application to the Legislative Council for final approval.
In 2013, the University of Hong Kong's public health department published a thesis by Kitty Chan Tsz-ki suggesting that it usually took 18 to 24 months to go through the three-step procedure before a proposal is presented to Legco.
But before a drug is offered at public hospitals, it is subject to another evaluation by the Hospital Authority, which will then decide whether to include it as free standard treatment or as a self-funded option for patients.
The paper, which was the first to evaluate the local drug regulation system alongside that of other countries, concluded that the local system was "relatively simple and stubborn" compared to other places.
It reported that Singapore could register a new drug in just 60 days and had the largest resources for researching and developing new medicine among all Association of Southeast Asian Nations countries.
In Hong Kong, only around 20 to 50 new drugs are registered in the city every year, according to Health Department data, compared to around 100 in Singapore. The thesis said there was a need for Hong Kong to speed up the process and make the system more flexible while balancing it against the safety of the new treatment.
Professor Thach Thuan- Quoc, who supervised the study, said it should be sufficient for the local authorities to consider approving a new drug if it gains recognition from just one international authority, instead of the two now required.
William Chui Chun-ming, president of the Society of Hospital Pharmacists, while acknowledging it is taking too long before patients can access new drugs, suggested the delay might be due to the economics of the health care system.
It was understandable, he said, for the government to be cautious in approving potentially expensive new drugs for use in public hospitals, as the city relies heavily on the publicly funded health care sector.
"It is the government's responsibility to consider the cost and benefits of certain new drugs, especially if they are very expensive, as they are managing taxpayers' money," said Dr Stephen Chan.
"In Singapore, there is less concern for the government as patients are usually covered by medical insurance."
Hospital Authority director of cluster services Dr Cheung Wai-lun agreed, noting that some expensive drugs are not much better than cheaper ones that may cost around HK$10 a dose.
"From an ethical viewpoint, doctors have to protect the rights of patients. If two drugs are similar, why don't they choose a cheaper one?" Cheung asked.
Still, it is probably true that Hong Kong has yet to find the right formula in juggling the need to be cost-effective, ensuring patient safety and guaranteeing timely access to effective medication.
http://m.scmp.com/news/hong-kong/health-environment/article/1853881/experts-call-hong-kongs-drug-approval-system-be
