Vast market catches eye of drug and medical device makers

It was a significant moment for world healthcare when two global pharmaceutical companies looked to China as the first country for approval of a new drug-bypassing the United States and European nations.

In December, the National Medical Products Administration approved Roxadustat, a drug developed by AstraZeneca and FibroGen, as a new treatment for anemia caused by chronic kidney disease in patients dependent on dialysis.

Chris Chung, managing director of FibroGen China, said in a statement: "Almost 10 years ago, Fibro-Gen made the decision to develop Roxadustat in China as a domestic Class 1 innovative drug. This arose from a commitment to give Chinese patients accelerated access to critically-needed innovative medicines. We are grateful to the patients and physicians in China who participated in our clinical studies."

The approval was supported by a phase III clinical trial (the final stage of a drug's development) in China, and the two companies, who expect to launch Roxadustat by the second half of this year, are working to get it approved in other markets.

The decision to launch the drug first in China reflects the newfound importance of the country's healthcare market and its emergence as a priority for global drug and medical device makers.

The healthcare system has undergone various revamps in recent decades, with much being achieved through State-sponsored care programs and multiple national health campaigns.

In October 2009, the country said it intended to provide universal healthcare by 2020 through the Healthy China 2020 initiative.

Helen Chen, Greater China managing partner at L.E.K. Consulting, said changes made that year were a turning point for the country's healthcare system.

"Healthcare reform in 2009 significantly strengthened the healthcare infrastructure, such as having a Level 2 hospital of 100 beds or more in every county, and also provided near-universal insurance coverage," Chen said.

"Essential drugs were introduced, and broader funding meant that mandatory vaccines became available nationwide. These substantially eased problems such as difficulty in securing a doctor's appointment, and expensive treatment, which were affecting the public."

By 2012, some 95 percent of the population had health insurance coverage. The program also included a focus on disease prevention through the promotion of healthy living.

In 2016, Margaret Chan Fung Fu-chun, then-director-general of the World Health Organization, said in a statement: "It's time to put people first. This means strengthening services at all levels, from community through hospital care back to the community, and linking them more effectively, so people get the care they need every step of the way.

"It's also time to work more efficiently across sectors to protect people from risks such as smoking and unhealthy diets, and prepare them to age healthily."

Sakshi Sikka, a pharmaceuticals and healthcare analyst at Fitch Solutions, said China's universal healthcare system has evolved to cover more of its huge population.

"Over the years, the Chinese government has launched ambitious healthcare reforms with the aim (of achieving) equitable access to healthcare services. The government developed a system of universal medical insurance with three major programs," she said.

"The first was the Urban Employee Basic Medical Insurance Program, which was launched in 1999, covering individuals who are employed in cities. The second was the Urban Resident Basic Medical Insurance Program, which was launched in 2007, for urban residents who are unemployed.

"Then there is the New Rural Cooperative Medical Insurance Scheme for rural residents, which was also launched in 2007."

These programs are meeting a large part of the country's pharmaceutical costs.

Sikka added, "They were followed by a round of healthcare reforms in 2009, when China substantially increased investment to expand the health infrastructure, strengthen the primary care system and reduce the number of people being left out-of-pocket.

"In 2016, the central government reshaped health reform through the 13th Five-Year Plan (2016-20) and the 2030 Healthy China campaign," she added.

"Finally, in 2018, the government promised to further reform the healthcare and elderly care systems, raise insurance benefits and increase per capita government subsidies for public health services. Over the years, these reforms have enabled a significant improvement in healthcare access and led to an increased demand for medicines, providing opportunities for healthcare providers and pharmaceutical companies."

Sikka said the universal healthcare system has two key benefits.

"China's expanded medical insurance coverage at each stage significantly boosted drug sales growth, with accelerated expansion following the introduction of government-sponsored medical insurance plans," she said.

"Moreover, out-of-pocket spending significantly declined, from 52 percent in 2005 to 28 percent in 2016."

In addition to a reduction in spending, more treatments are being approved in the country at a faster rate.

Chen, at L.E.K. Consulting, said, "Most recently, the innovation drive (supported by the National Medical Products Administration-the former China Food and Drug Administration) has streamlined the drug registration process, and reimbursement for newer, more innovative and higher-value therapies is now taking place. These are all exciting for the industry."

She said clarification on the use of global data in clinical submissions in China is a particularly important step.

"We also see new entrants to the broader healthcare system, with technology companies like Tencent and Alibaba, or insurance companies such as Ping An, introducing different ways to look at the business and potentially create disruptions," Chen said.

Increased healthcare research and development is bound to see the country advance in certain fields, Chen said, adding, "China is quite active in a number of new research areas, such as AI (artificial intelligence) for image reading and CAR-T (cell therapy) research."

This improved research and development, along with stronger intellectual property protection, could increase innovation in the healthcare sector.

Lewis Ho, a partner in the life sciences practice at law firm Loeb & Loeb, said: "The intellectual property protection system is getting better. Most companies would acknowledge it has generally improved.

"With Chinese companies now generating many patents, there is more reason than ever to improve the system, as they have their own patents to protect."

Chen praised the streamlining of the drug registration process, but said it could be improved for medical devices. "Unfortunately, the medical devices registration process continues to be confusing and subject to individual reviewer interpretation."

She also said other areas of the healthcare system could be improved.

"Some fundamental issues in the system, such as the low salaries of physicians and nurses, remain. This is a complex issue that will require significant coordination and further structural changes," Chen said. "Another issue is that healthcare service fees do not fully cover the cost of provision."

She added that some local governments had attempted to address this by raising fees, but were met with protests from patients, who took to the streets to demonstrate.

The aging population could also prove taxing for the universal healthcare system. In a report in 2016, the World Bank Group said there were 140 million people in China age 65 and older. The number was expected to rise to 230 million by 2030.

It also noted a surge in noncommunicable diseases such as cancer, diabetes and heart disease.

According to a two-year study by the World Bank Group, the World Health Organization and several Chinese ministries, the country has lifted more than 600 million people out of poverty in the past three decades and achieved noteworthy successes in health reform.

The World Bank Group's 2016 report urged China to maintain its goals and direction of healthcare reform. This could be achieved by continuing the shift from a "hospital-centric" model that focuses on volume and sales to one that is centered on primary care.

Jim Yong Kim, who was president of the World Bank Group until Feb 1, said in a statement, "Decades ago, China's innovations in health such as the introduction of barefoot doctors (village physicians) and cooperative healthcare showed the world it was possible to improve health and greatly increase the life expectancy for hundreds of millions of people.

"Today, China can once again lead the way with cutting-edge primary healthcare reform that puts the patient first and moves away from expensive hospital care that often does little to improve people's health," Kim said.