Is collaboration between doctors and industry corrupt? This is the key enterprise | doctor | key
In this round of pharmaceutical anti-corruption, the relationship between doctors and enterprises has become delicate, leading to concerns about the involvement of some normal clinical cooperation and development projects. It seems that once there is an association between people in enterprises and doctors, it is suspected of profit transmission. Industry insiders suggest that the misconception that "cooperation is the transfer of benefits" should be eliminated in order to properly view the inseparable relationship between doctors and the industry.
In the first two articles of the "Questioning Good Doctors" series, we have already explored what kind of doctors are needed and how to cultivate more doctors who can see doctors. And excellent clinical doctors require innovative thinking, which cannot be separated from cooperation with industry and industry. The purpose of combining medical and industrial work is also to better meet the needs of patients.
A recent video interview by Professor Yang Bo, a medical doctor at the University of Michigan Cardiovascular Research Center, has been widely circulated. Yang Bo said, "The public should have an objective evaluation of doctors, and the cooperation between doctors and industry should be very close. The original view in the United States was also that if a doctor has a connection with industry, it seems that the doctor is corrupt. Later, people realized that the situation was not like this. Working together with industry can improve the quality of products and better serve patients."
He also believes that industry support for various academic conferences and training and education for doctors is also a good thing. For example, young doctors in Asia can also go to the United States for training, and these can help doctors improve their skills, especially young doctors. "You shouldn't see a doctor collaborating with a company and think that the company has given doctors millions to use their products, but that's not the case at all," Yang Bo said.
How can collaboration between doctors and the industry be carried out in the right way? How to avoid potential benefits transfer? To this end, First Financial reporters interviewed multiple doctors and industry professionals. Some interviewees told First Financial reporters that if they believe that doctors are suspected of profit transmission in their interactions with companies, then this concern theoretically also exists in any industry that deals with public officials, such as university professors and industry collaborations, which may also be questioned.
Industry insiders unanimously agree that cross-border cooperation between medicine and engineering is a trend in the development of modern medical technology. The progress of medicine cannot be separated from the support of the industry, and a reasonable institutional design can make the cooperation between the two more "smooth".
The combination of medical and engineering can better promote the development of the industry
"Cross cooperation between medical and industrial sectors is a natural, natural, and mutually beneficial thing." A founder of a domestic medical device company told First Financial reporters, "The combination of medical and industrial sectors can help doctors understand the characteristics and usage requirements of new products in a timely manner, which is beneficial for improving clinical skills. On the other hand, it can truly achieve innovation and medical transformation, promote industry development, and should not demonize or stigmatize the cooperation between doctors and enterprises."
The head of a multinational medical equipment company in China also told a reporter from First Financial News, "Multinational enterprises actually undertake a lot of foreign new technologies and product training, including drugs, as well as important scientific research work. Doctors and enterprises complement each other to improve the level of medical technology."
Lawyer Gu Yang from Hankun Law Firm told First Financial reporters, "Objectively speaking, the development of the pharmaceutical industry cannot be separated from the cooperation and interaction between doctors and pharmaceutical companies. If pharmaceutical companies develop innovative pharmaceutical products that can meet some clinical unmet needs, but do not communicate with frontline doctors, it may lead to doctors' insufficient understanding of relevant pharmaceutical products and subsequent medication guidance for patients, and related products cannot benefit patients with urgent clinical needs."
The chief physician of a top tier hospital in Shanghai told First Financial reporters that in terms of medical devices, there are generally two types of cooperation between doctors and the industry. One is when doctors discover problems in clinical practice and need solutions, but because doctors do not have an engineering background, the industry needs to help realize their ideas; Another type is that companies do not know the clinical needs and pain points of doctors in the product design process, because engineers do not have a medical background, so they need the participation of doctors to solve practical clinical problems.
"There are many of these two situations, some are companies that find us, some are companies that we need. The most important thing is to have a legitimate and compliant channel and platform that connects doctors and companies, so that both parties can achieve mutual success." The chief physician mentioned above told the reporter of First Financial.
A senior executive of a cardiovascular medical device company under Minimally Invasive once said in an interview with First Financial reporters, "Our cooperation with clinical doctors is very close, because the development of new medical devices must have certain clinical value, but our engineers do not have clinical knowledge. To develop medical device products that meet clinical needs and are valuable, we must work closely with doctors to understand their clinical needs."
"Innovation often comes from unmet clinical needs on the front line, and the pain points and difficulties in clinical practice are the source of innovation." A senior medical industry expert with over 20 years of experience in clinical project development told First Financial reporters, "The key is the issue of institutional design. The cooperation between doctors and enterprises in developed countries is rarely questioned because the system is very perfect."
There is still a "fuzzy zone" in the innovation and transformation system
According to a reporter from First Financial News, although doctors participating in external research and development projects generally require informing hospitals or participating through hospitals, in reality, these regulations still have "vague areas" and there is no clear guidance document.
A founder of a domestic medical equipment manufacturer told First Financial reporters that the most reasonable and legal way for doctors to cooperate with enterprises is through technological innovation and transformation. This is also the reason why hospitals have emphasized innovation and transformation in recent years.
First Financial reporters learned from some hospitals in Shanghai that currently, for medical innovation research and development projects in which doctors participate, more than 80% of the final product income after being converted to enterprises can be given to individual doctors, who will be internally distributed by the first inventor. This proportion is higher than the current policy's minimum guidance line of 70%.
"I believe that as long as income distribution is carried out under intellectual property regulations, it is reasonable and legal. Of course, it is best for doctors and enterprises to cooperate through hospitals, and it is also reasonable for job inventions to go to hospitals." A doctor engaged in medical innovation transformation told First Financial reporters.
In addition to collaborating with doctors to develop early products, clinical doctors also undertake a large number of clinical trials of new products for enterprises. "Usually, in terms of clinical trial cooperation, we usually cooperate with hospitals and rarely involve individual doctors," a senior executive of a domestic medical device company told a reporter from First Financial.
Regarding what kind of system we need to prevent doctors from being criticized to the greatest extent when cooperating with enterprises, Gu Yang told a reporter from First Financial News, "To dispel everyone's prejudice and misunderstanding about the cooperation between doctors and pharmaceutical enterprises, it is necessary for doctors and pharmaceutical enterprises to cooperate on the premise of strictly complying with anti-corruption and anti bribery compliance requirements."
He said that China's regulatory regulations have set a red line for anti-corruption and anti bribery supervision, which is to "eliminate the transmission of improper benefits" for the interaction activities between doctors and enterprises, and must be strictly followed; In addition, specific compliance standards in business practice will be jointly established and maintained by industry practitioners.
A clinical doctor from a top tier tertiary hospital with multiple invention patents told a reporter from First Financial News, "I believe that if what doctors produce is innovative, they can be allowed to participate in the industry, which is conducive to overall medical innovation and the development of medical industry integration. However, if doctors do not participate in substantive research and innovation, such as obtaining product sales benefits from the enterprise without converting patents, there is a risk of suspected benefit transmission, and this is also the case in foreign countries. Society should have a tolerant attitude and cannot generalize, otherwise true medical industry integration cannot be achieved, and the value of doctors will also be difficult to reflect."
Regarding how to distinguish whether doctors use their own companies or joint stock companies to sell products to the industry for unfair benefits, Gu Yang explained to a reporter from First Financial News, "If doctors open their own companies or joint stock companies to represent products and then prescribe and sell their own products, it is generally not accepted in the industry because doctors have influence based on their position and prescription rights, and there is a conflict of interest. Conversely, if doctors develop and promote innovative products and sell them to the entire industry instead of just prescribing them, it is generally acceptable."
He added that the latter situation is actually the most natural route of technological transformation. For example, many professors and doctors from universities, scientific research or medical institutions incubate new technologies through research and development, and then choose to license and authorize corresponding intellectual property rights to domestic and foreign industries through the market. On the one hand, the blooming and fruiting of new technologies can rely on the strength of the industry, and on the other hand, the market also feeds back scientific research.
Fang Shilong, Director of the Tort Liability Committee of the Shanghai Bar Association and Partner of Guohao Law Firm, also holds a similar view. He told a reporter from First Financial News, "I think from a product perspective, if doctors participate in a company and the company produces completely innovative products, then doctors are encouraged by current regulations to invest as technology. However, if doctors participate in or invest in a mature company with mature products for sale and only one or two new products, then there is suspicion of profit transmission. It mainly depends on what kind of activities doctors engage in in in the company, whether it is innovative research and development or sales activities. It may be easier to distinguish whether there are illegal and irregular behaviors from this point on."
He also stated that fundamentally, anti-corruption actions should not undermine the innovative atmosphere of the industry and the innovative enthusiasm of doctors, otherwise the biggest victim would still be patients. "The pilot plan for the transformation and innovation of scientific and technological achievements recently introduced in Shanghai emphasizes the granting of ownership and long-term use rights to scientific and technological achievements to researchers, which is a great progress," Fang Shilong told reporters from First Financial News.
The detailed rules for the integration of industry and medicine in Shanghai have been released
An expert in the medical field also pointed out that from a policy perspective, in recent years, the national and local governments have introduced many policies to encourage talent innovation, including in medical institutions. From the transformation of scientific and technological achievements to the distribution of transformation benefits, they have provided sufficient support.
According to public information, as early as early as 2020, the Ministry of Human Resources and Social Security issued the "Guiding Opinions on Further Supporting and Encouraging Innovation and Entrepreneurship of Scientific Research Personnel in Public Institutions", supporting and encouraging public institutions to send professional and technical personnel to enterprises for temporary employment or participate in project cooperation, and to distribute rights and interests based on the new technologies, new materials, new varieties, as well as transfer and development benefits formed by the services of professional and technical personnel, promoting scientific and technological innovation and the transformation of scientific and technological achievements into real productivity.
According to the "Operating Rules for Promoting the Transformation of Scientific and Technological Achievements in Medical and Health Institutions in Shanghai" released at the end of last year, in terms of the integration of industry, academia, research and medicine, it is proposed to support open innovation of enterprises in the medical and health industry, guide them to establish various forms of innovation alliances with medical and health institutions, carry out cooperative research and development, improve profit sharing mechanisms, and promote collaborative innovation across multiple fields and industries. Encourage the co construction of a concept verification platform between industry, academia, research, and medicine. Through concept design, commercial evaluation, intellectual property evaluation, medical evaluation, seed funding, and other concept verification activities, verify the commercial potential of specific technologies, propose directions and suggestions for the commercialization of scientific research achievements, and attract social capital investment.
In terms of income distribution, the "Detailed Rules" stipulate that for those who transform their professional scientific and technological achievements through technology transfer or licensing, a proportion of not less than 70% of the net income obtained from technology transfer or licensing shall be extracted to reward the person who completes the scientific and technological achievements; For those who invest and convert scientific and technological achievements based on their value, a proportion of no less than 70% shall be extracted from the shares or contribution ratio obtained from the investment based on their value to reward the completion of scientific and technological achievements.
In terms of promoting achievements, the "Detailed Rules" point out that medical institutions are encouraged to hire entrepreneurs, investors, technology talents, and other qualified personnel with innovation, entrepreneurship, or investment experience to engage in the transformation of scientific and technological achievements and receive corresponding compensation; Conditional medical and health institutions can independently build or participate in the construction of clinical research centers, technology enterprise incubators or crowdsourcing spaces, technology achievement transformation platforms and other carriers, and rely on these carriers to implement technology achievement transformation; Mobilize medical and health technology personnel, high-level experts, and industry experts to go deep into the grassroots frontline to provide technical consultation, technical services, scientific and technological breakthroughs, and achievement promotion and other technical services, to solve the technological innovation of the medical and health industry and the practical needs of the health field.
"The country has long introduced incentive policies, and now it is time to re-examine the policies at that time and see how they are implemented," a medical enterprise insider told a reporter from First Financial News.
A professor from a top tier tertiary hospital told a reporter from First Financial News, "Although we have seen many policies that support innovation, many of these policies are incomplete or lack clear guidance paths. This is the biggest problem we are currently facing, which is the lack of a mature mechanism in the middle that can truly turn innovative ideas into innovative products or therapies through reasonable paths."
The above professor stated that looking back at the development history of human medicine over the past 100 years, many innovative therapies and medical device products from scratch have occurred under the joint promotion of the medical and industrial sectors, and China must also go through such a process. When formulating policies in relevant departments, detailed rules and operability are very important.
