Government officials bowed to pressure from the beauty industry and watered down a proposal to protect customers from salons hawking risky treatments using medical devices, according to lawmakers.
Civic Party legislator Dr Kwok Ka-ki was among those chastising authorities and calling on the Food and Health Bureau to revert to its original proposal circulated in January 2017, after it issued a revised version last week.
“You are backing down completely,” he told undersecretary for food and health Dr Chui Tak-yi on Monday during a meeting of the Legislative Council’s health services panel.
The changes included the removal of recommendations to restrict the use of high-risk medical devices, including those used for laser surgery, focused ultrasound and intense pulsed light therapies.
There are currently no rules on the use of medical devices – which include a wide range of items from hot and cold packs to breast implants.
Manufacturers and importers can voluntarily inform the Department of Health of the types of items brought into the city, and report any adverse incidents.
In 2012, a shocking blunder left one woman dead and three others seriously injured. They had paid thousands of dollars for experimental cancer therapy, which involved extracting and processing their blood and then injecting it back into their bodies.
The woman died after she suffered septic shock and the incident resulted in two criminal convictions last December.
Efforts to better regulate such treatments resulted in the government’s proposal in January 2017 to restrict the use of 20 types of medical device involved in cosmetic treatments. Doctors would need to be present or supervise the use of some devices.
Traders would also be required to register devices before selling them in the city and to set up a post-market surveillance system to monitor the performance of products.
The government then spent the past year consulting the industry and other stakeholders.
Last week, in announcing the revisions, the government removed the initially suggested usage controls, saying it would defer the inclusion pending further discussions.
Under the new proposal, the Department of Health would accept direct applications for registration from traders of medical devices which have been approved by mainland China and South Korea, in addition to those approved by the International Medical Device Regulators Forum.
There would be a five-year grace period for registering devices, and those already registered would need to have their permits renewed every five years. To ease fears over safety, the government proposed that devices used for cosmetic procedures be registered, even during the grace period.
Chui told Legco’s health services panel on Monday there were divergent views on usage control after consultations with the beauty industry and health professionals.
Helena Wong Pik-wan from the Democratic Party said it was important to legislate devices that could “harm people”, adding: “I don’t know what industry pressure has been put on the government.”
Labour Party lawmaker Fernando Cheung Chiu-hung said: “I worry Hong Kong will become a dumping ground for unscrupulous equipment.”
While the Liberal Party’s Peter Shiu Ka-fai was also among the critics of the new proposal, he argued that having a doctor present or to supervise the use of cosmetic devices did not mean the equipment was “completely safe”.
Deputy secretary for food and health Howard Chan Wai-kee said the government did not want to delay the registration of “tens of thousands” of devices, which would also include those used for medical procedures.
Kwok’s motion expressing regret at the watered-down bill and urging the government to install regulations, including on the cosmetic use of medical devices, was passed with five lawmakers supporting and two opposing it.
A bills committee was expected to be set up in the next legislative session, for detailed scrutiny of the draft bill.
Amy Hui Wai-fung, chairwoman of the Hong Kong Beauty and Fitness Professionals General Union, said monitoring imports of devices would protect Hong Kong from fakes or those that were not approved overseas. She said there were about 6,000 to 8,000 beauty salons in the city.
Frances Chiu Siu-ling, chairwoman of the Federation of Beauty Industry, said devices used in beauty care should not be classified in the same way as medical devices.
“The Federation of Beauty Industry (HK) holds the view that the regulation of devices should be dependent on the nature of operations, thus medical devices and beauty care devices should be regulated under separate regulatory systems and standards,” Chiu said.