For Shengshi Biotech President Miles, April 28, 2014 is an important day worth remembering.
On the same day, at the “4th International Conference on Molecular and Cellular Biology” held in Dalian, Shengshi released the world’s first umbilical cord pluripotent stem cells with patented quality control.
In the field of stem cells, setting standards is a remarkable initiative. Even Nobel Prize winner Daniel Shechtman, who was present that day, praised this achievement. But in Miles’ heart, there is always a trace of regret alongside happiness.
Just one year before Shengshi released quality control standards for stem cells, in February 2013, the international ISO standardization organization announced the establishment of the International Biotechnology Committee, which is responsible for formulating international standards for quality control of stem cells. The secretariat is located in Germany.
Before that, Shengshi’s pluripotent stem cell quality control standards, including the framework and content, had been formulated. Being “squatting” by Germany is not only a loss for enterprises, but also means that China can only participate in the formulation of standard content as one of the member states, but unfortunately it has lost the opportunity to guide the formulation of international standards and the right to speak in the industry.
Although China still has a huge market and resource reserves, this may be able to win back China’s clinical application of stem cells in the future. But the prerequisite for achieving all this is that domestic stem cell regulations and standards are formulated and promulgated as soon as possible.
The reality is exactly the opposite. It is precisely because of the lack of industry and national standards that stem cell research and clinical applications in China have been developing in a state of chaos and disorder, which ultimately led to supervisors
The department issued a notice in 2012 to stop it. Since then, although the national competent authorities have been interested in re-promoting the formulation of stem cell industry regulations and technical standards, the opportunity has been missed again and again, and many actions have ended in vain.
Nowadays, under the trend that developed countries in Europe and the United States regard stem cells as a strategic industry and vigorously support them, the formulation of unified stem cell management regulations and standards has become the most urgent hope of all sectors of my country’s stem cell industry, academia and research.
Missing international standards
“This standard framework was originally proposed by Chinese companies, but now it has suddenly become a German achievement.” When talking about the “squatting” behavior of the German Standardization Association, Miles was very indignant.
“We were all shocked after the news from the International Organization for Standardization was announced,” said Li Li. “The content framework, as well as the terms and definitions, of the international standard for stem cell quality control proposed by Germany are exactly the same as the corporate standards proposed by Shengshi before.”
In the standard framework of the International Committee on Biotechnology, stem cells and stem cell storage are defined as “life resources” and “life banks” respectively. This is exactly the same wording used by Shengshi in public promotional materials before 2013.
More importantly, in the international standards framework proposed by Germany, the division of specific standards, such as analytical methods, biological processes, etc., is completely consistent with the concept first proposed by Shengshi.
The source of the information leakage can no longer be traced. Miles told reporters that Shengshi had previously elaborated on the definition and general framework of this standard on the company’s website, which may be one of the sources for industrial espionage to obtain information. In addition, as an investor, in order to expand business in Europe and the United States, she has contacted many investment groups in Europe in the past few years, including many investors related to German companies.
Even the laboratory computers and hard drives of Shengshi’s headquarters in Beijing have been stolen.
Waiting until the end of the road, it was too late to officially announce the stem cell quality control standards of Shengshi. “From the perspective of foreign countries, all subsequent breakthroughs and achievements in stem cell quality control standards around the world are just specific work done in the standard framework advocated by Germany.”
Since the German Standardization Association successfully applied in 2013, it has not formulated any actual content within the two-year standard framework.
Miles said that Shengshi had not considered applying for national and international standards before. However, China’s national standards for stem cells are different from those abroad.
For example, in Germany, enterprises propose enterprise standards, and the German Standardization Association formulates industry standards or national standards based on enterprise standards. Finally, based on industry or national standards, it applies to the International Organization for Standardization for international standards.
China’s process is exactly the opposite. According to the “Standardization Law of the People’s Republic of China”, national standards must be formulated using the “standard adoption” method, that is, international standards are adopted and my country’s national standards are formulated based on international standards. If an enterprise, industry or national standard wants to become an international standard, it needs the lead organization of the National Standards Committee and relevant industry authorities to apply for project approval from the national standards organization.
The whole process not only takes a long time, but also has to overcome disputes among various interest groups within the industry, which company or institution’s standards should be based on, who will take the lead, and how to promote it. Domestic conservative regulatory policies and chaotic clinical market conditions also make standard application even more difficult.
Domestic standards dispute
To this day, the problem of lack of standards has always been a sharp sword hanging over the head of China’s stem cell industry.
Stem cell therapy products will eventually be used in the human body, so quality control standards and quality assurance systems must be established to systematically implement the entire process of donor screening, tissue collection, cell isolation, culture, cryopreservation, recovery, release, transportation, and use to ensure the safety, effectiveness, and stability of the product.
Wu Weihong, vice chairman of the China Industry-University-Research Alliance for Stem Cell Transformation Medical Standards, said that due to the lack of technical standards and regulations, China’s stem cell market has been in chaos before, and the entire stem cell industry has also suffered. Establishing China’s stem cell technology and clinical application specifications as soon as possible and formulating unified and systematic quality control standards have become urgent demands from all walks of life in industry, academia, and research.
In fact, the national industry authorities have not considered formulating my country’s stem cell technical specifications and standards.
Xi Tingfei, director of the Center for Biomedical Materials and Tissue Engineering at Peking University, said that as early as 2008, after the former Department of Science and Education of the Ministry of Health took over the supervision of stem cells, it organized the China Medical Biotechnology Association, the Chinese Medical Association, the Chinese Medical Doctor Association and other units to draft management measures related to stem cells.
However, because the expert team responsible for clinical project review is mainly professors from scientific research institutions and universities, it is too mobile, and the Department of Science and Education does not have the power to supervise law enforcement. The entire management method lacks an operational organizational implementation plan, and it cannot be implemented, and ultimately it was abandoned.
Later, in March 2013, the former Ministry of Health and the State Food and Drug Administration jointly issued three “Drafts for Comments”: “Stem Cell Clinical Trial Research Management Measures”, “Stem Cell Clinical Trial Research Base Management Measures” and “Stem Cell Preparation Quality Control and Preclinical Research Guiding Principles”.
However, as soon as the “Draft for Comments” came out, controversy arose. Most comments believe that the “Draft for Comments” brings good news to stem cells, and that China’s stem cell industrialization is accelerating and entering the fast lane. This system will manage stem cell clinical application research in comparison with national first-class new drugs, which can fill the gap in the supervision of the domestic stem cell industry.
However, some experts believe that the “Solicitation for Comments” is unclear on some specific contents and standards, which will bring confusion to the stem cell industry.
On the issue of standards, although the “Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations” also proposes specifications for some processes such as stem cell preparation and testing, it does not provide specific indicators for the preparation process and quality control, and there is no clear technical standard indicator distinction for different types of stem cells.
In addition, Zhang Lei, director of the Chinese Society for Bioengineering, said that the “Draft for Comments” did not clarify the specific division of labor, review procedures and regulatory authority of the Ministry of Health and the State Food and Drug Administration in the registration and acceptance process of stem cell clinical trial research, which would inevitably lead to a situation of buck-passing between departments; the method did not even clarify the purpose of stem cell clinical trial research. Even if clinical research is completed, there is still no registration channel for stem cell products, failing to provide an outlet for the industrial development of stem cells.
Realistic challenges
Theoretically, this problem is not unsolvable. According to normal logic, according to the normal logic, as long as the national competent authorities take the lead, organize relevant enterprises and institutions, and declare the enterprise’s technical standards as international standards. This can not only lay the foundation for national standards, but also make up for the regret of “squatting” of the standard framework.
Wang Zongling, Secretary of the Party Committee and Vice President of the China Institute of Standardization, told the reporter of Financial National Weekly that the Institute of Standardization has also signed an agreement with Shengshi, entrusting Shengshi to compile the quality control standards for umbilical cord pluripotent stem cells in order to apply for ISO international standards.
The early writing work is not a problem. After all, there are mature corporate standards of Shengshi as a reference basis. The subsequent application work is the real challenge.
Wang Zongling told reporters that according to normal procedures, from the completion of writing to the organization’s application for project approval to the review and approval by the International Biotechnology Committee, the entire process will take 10 months at the fastest. However, this is only an ideal state. Within the rules of the game set by developed countries in Europe and the United States, it has been very difficult for China’s standards to go global.
In fact, this problem is not limited to China, but also to other countries outside the United States and the European Union. Before the German Standardization Association “rushed to register” the definition and framework of international standards, South Korea and other other countries also applied to the International Organization for Standardization for quality control standards, but they were quickly rejected. Only the German Standardization Association’s application was quickly approved.
Wang Zongling believes that in the context of increasingly fierce competition in global stem cell technology research and industry, the resistance that China’s stem cell quality control standards will encounter if it wants to become a global international standard can be imagined. To win this battle for standards, in addition to the existing mature and high-level corporate standards, according to Zhao Chunhua, director of the Tissue Engineering Research Center of the Chinese Academy of Medical Sciences, the trump cards that my country can rely on now include the large amount of data and cases accumulated in stem cell clinical research before 2012, as well as China’s huge market and stem cell resource potential.
In addition, at the beginning of 2015, some media reported that the National Health and Family Planning Commission and the State Food and Drug Administration were working hard to formulate the official drafts of the above three “Drafts for Comments”, which were nearly completed and were expected to be completed and officially announced in the near future.
The problem is that there is not much buffer time left for our country to make good use of these trump cards. Guo Lei said that the United States is currently at the forefront of stem cell clinical research in the world. Currently, the United States also lacks corresponding technical standards and clinical data support. Once the United States completes standard research and technical reserves, because the clinical application policy environment is better than China, short-term effects of disease treatment can be seen at the earliest in about two years.
By then, the advantages that my country has accumulated in clinical research and application will no longer exist, and the gap between the clinical application and industrialization level of the entire stem cell technology and foreign countries will be further widened.