The first imported medicine under the connect — Rho(D) immune globulin, a blood disease drug — is boxed in a medical cold chain container to go across the border. (PHOTO PROVIDED TO CHINA DAILY)
A 9-year-old boy from a small town in Hebei province has been struggling with severe scoliosis for three years. His parents have been to all the major hospitals in Beijing and were told to insert a growth rod into the child’s back.
Initially, his mother hesitated as the surgery needs to be repeated every six months, and it would require more than a dozen operations before the boy recovers fully. Each time, her son’s back would have to be opened wide up using anaesthesia, causing possible complications.
Scoliosis is a medical condition in which a person’s spine has a sideways curve. The abnormality is most common among people aged between 10 and 20. In more severe cases, it can hinder breathing and movement.
Earlier this year, a Beijing doctor told the family that a new treatment requiring a single minimally invasive operation would soon be put into clinical use at the University of Hong Kong-Shenzhen Hospital.
The boy successfully underwent surgery in May. His mother was relieved when she saw how small the surgical wound was. The boy is said to be in a very good condition and has left hospital, walking freely. On the Chinese mainland, there’re still tens of thousands of children with the condition.
Medical experts believe the program will elevate Hong Kong's status in the international pharmaceutical industry in terms of academic innovation, new product development and market expansion, as well as the availability of more international medical products
It was the first such operation carried out on the mainland using the first medical device obtained from the launch of the Hong Kong and Macao Medicine and Equipment Connect. The program allows designated mainland hospitals to use Hong Kong-approved drugs and medical devices without prior certification from the National Medical Products Administration.
Mainland patients, including Hong Kong residents living on the mainland, are the main beneficiaries. Medical experts believe the program will elevate Hong Kong’s status in the international pharmaceutical industry in terms of academic innovation, new product development and market expansion, as well as the availability of more international medical products.
More importantly, it’s an attempt to link up review standards and system for medical products and personnel in the Guangdong-Hong Kong-Macao Greater Bay Area, taking the region closer to being a global healthcare center.
The boy’s operation was performed by well-known Hong Kong surgeon Kenneth M.C. Cheung, who had to spend 14 days in quarantine in Shenzhen in April before carrying it out.
Cheung is the first medical expert worldwide to use the magnetically controlled growing titanium rod, and has been performing similar operations for more than a decade. The rod can be stretched outside the patient’s body every two to three months after implantation by a magnetic instrument, avoiding further large-scale surgeries.
Pilot program
Cheung has been vigorously pitching the HKU-SZH — the only pilot hospital to implement the new connect policy so far — to include titanium rods in the first batch of medical equipment to cross the border. “Last year, as soon as I heard of the policy, I approached the Shenzhen hospital immediately,” he recalled.
HKU-SZH, built and funded by the Shenzhen municipal people’s government, is a public hospital in Shenzhen’s Futian district and one of the University of Hong Kong’s two teaching hospitals. When it opened in 2012, it was described as a key part of the overhaul of China’s healthcare system.
In Hong Kong, an average of five to 10 similar operations are performed annually, but at least 10,000 children may need the equipment on the mainland.
Hong Kong surgeon Kenneth M.C. Cheung (third from right) performs surgery on May 3, using a magnetically controlled growing titanium rod. (PHOTO PROVIDED TO CHINA DAILY)
"Our doctors will get more experience, along with more surgeries, so it’s a boon for training,” said Cheung. “As an academic center, we always hope to do research. The more cases, the richer the research results will be,” said Cheung, who heads the orthopedics and traumatology unit at the University of Hong Kong.
Lo Chung-mau, chief executive of HKU-SZH, said Hong Kong could become a medical research hub, attracting cutting-edge biomedicine research projects from all over the world. “A paramount benefit for Hong Kong is to jointly research and develop new medical products.”
For instance, a platform in a cross-border pilot zone could be set up to match new biomedicine technology developed by Hong Kong researchers with mainland institutions, and conduct clinical testing in the entire Greater Bay Area.
Moreover, he said the new channel can expand sales of medical companies. The hospital is purchasing a further 10 titanium rods. Each patient needs only one or two rods.
Lo said safety concerns will ensure the quantity won’t be extremely large initially. “The titanium rod producer has agreed to provide the equipment on the mainland because they knew Professor Cheung would perform the surgery,” he added, stressing the result of each case is important for the drug and medical equipment producers.
According to HKU-SZH, four other innovative medications have been approved and will soon be put into pilot use at the hospital, following the first drug and device applications.
The titanium rod is the first medical device imported through the Hong Kong and Macao Medicine and Equipment Connect. (PHOTO PROVIDED TO CHINA DAILY)
The first imported medicine under the connect program is Rho(D) immune globulin — a blood disease drug that was used clinically at the hospital on April 29. In addition, the clinical data collected from these applications could also help expedite national approval for related international drugs or devices.
The marketing of many medicines in Hong Kong is synchronized with the world because of mutual recognition, but the mainland needs to do its own clinical results for review and approval, said Huo Peiqiong, general manager of China Resources Guangdong Pharmaceutical — the import agent for the first drugs and equipment.
So registering in Hong Kong or launching the products in the Hong Kong market is much faster than on the mainland, she noted. For example, one drug can be listed in Hong Kong simultaneously in the United States or the United Kingdom.
The connect gives the green light for medicines that are already available in Hong Kong and Macao markets, so more international pharmaceutical enterprises would seek registration there because entering the two special administrative regions mean they could tap the Greater Bay Area or the entire mainland market sooner.
However, it wasn’t plain sailing for reviewing, purchasing and transporting the first batch of drugs and device through the connect. Huo recalled it took more than two months to have them delivered.
Many innovative measures were needed to lay a solid foundation for the potential expansion of the connect to more mainland cities. But in the absence of national approval, the import agent had to communicate back and forth between local evaluation authorities and pharmaceutical enterprises to provide proper materials for review.
Management teams from the University of Hong Kong-Shenzhen Hospital and China Resources Guangdong Pharmaceutical pose for a group photo with the first imported medicine and medical device under the connect on April 16. (PHOTO PROVIDED TO CHINA DAILY)
Innovative measures
In December 2020, the National Medical Products Administration set up a Greater Bay Area drug evaluation and inspection center in Shenzhen’s Futian district, dedicating itself to integrating the Greater Bay Area’s medical sector.
“One benefit of founding such an organization is that the review and clinical application data included in the center this time will directly go into the national database, substantially speeding up the national approval process,” said Huo.
“Another innovative measure we initiated is a special drug and device traceability system, she added. Compared to nationally approved products, which have official government codes, those under the connect need a new code system that can trace each process of transportation, customs information and origin.
After the successful application of the first drug and medical device, Huo said the medical connect will be expanded to more hospitals and cover further products.
China Resources has begun preparing the second batch of drugs and devices through the program, focusing on treating major and rare diseases, such as cancer.
In communicating with medical product suppliers, Huo said she found them to be “very positive” about the program. “Their teams on the mainland, in Hong Kong and their headquarters have actively cooperated with us.”
“As the largest medical product importer in South China, we have many hospital partners and many of them have shown great interest in the scheme,” she added.
Huo suggested the next step be to optimize the filing process, reduce filing time and track the effects of delivered products.
She estimated the company’s total import volume could exceed 8 billion yuan (US$1.24 billion) this year and continue to rise.
Many hospitals across the mainland have been keeping an eye on new medicine and equipment imported through the connect. The Hebei boy with scoliosis was referred to HKU-SZH by a well-known spine surgeon from the Department of Orthopedics at Peking Union Medical College Hospital. The surgeon had traveled from Beijing to Shenzhen to witness the surgery, showing great interest in bringing the method to his hospital.
In March, construction started on a healthcare center in Shenzhen’s Pingshan distrcit, attended by medical personnel and doctors from more than 50 Hong Kong clinics. In the same month, Guangzhou’s Clifford Hospital opened a new facility employing more than a dozen Hong Kong doctors. Both institutions have applied to become the next pilot of the connect. As the connect program involves more hospitals and drugs, the demand for Hong Kong medical professionals will rise as new drugs and devices have to be supervised or performed by experienced personnel.
Citing Cheung’s titanium rod surgery as an example, the Hong Kong surgeon said those who intend to perform similar operations in future will need at least five years’ experience in treating scoliosis or have performed more than 20 scoliosis surgeries.
Barriers remain for experienced Hong Kong doctors to practice on the mainland. According to mainland regulations, only chief physicians are allowed to perform level-four surgeries. Moreover, local qualification recognition is also tied to applications for scientific research funding.
To solve the problem, the Shenzhen government last month issued a document to promote the flow of cross-border medical services and resources. One of the key measures is to simplify qualification evaluation for Hong Kong and Macao medical personnel.
HKU-SZH is also a pilot hospital for implementing related measures in the document, including supporting top-end hospitals in reviewing professional titles itself. So far, more than 30 Hong Kong consultants have been recognized as chief physicians by the hospital, according to local media reports.
Contact the writer at grace@chinadailyhk.com