In recent years, around the commanding heights of biotechnology and the cultivation of new driving forces for the development of the pharmaceutical and health industry, countries have successively issued policy measures to accelerate the breakthrough of medical biotechnology innovation. At the same time, European and American countries continue to strengthen the strategic competition with China's biotechnology, attach importance to the supply chain security in the field of domestic health care. Under the trend of globalization and integration of the pharmaceutical and health industry, countries continue to strengthen regulatory cooperation to ensure drug supply and promote industrial innovation and development.
The world's major economies drive innovative breakthroughs in medical biotechnology
The United States will explore the establishment of a national research platform, strengthen the national strategic scientific and technological strength, and crack the bottleneck of the operating mechanism of medical research and innovation
In April 2021, the Biden administration proposed the creation of the Advanced Health Research Projects Agency (ARPA-H). The department, which operates out of the National Institutes of Health (NIH) with a requested budget of $6.5 billion, is modeled after the Defense Advanced Research Projects Agency (DARPA) to accelerate the development of medical technologies by funding high-risk innovative projects, with a particular focus on cancer, diabetes and Alzheimer's disease. While pursuing other "transformative innovations" that could reshape health research. With existing funding mechanisms, NIH's support for scientific projects tends to be incremental, hypothesis-driven research, while the commercialization sector requires expected returns on investment within a reasonable time frame to attract investors, and some of the most promising innovative ideas may never mature. Although the establishment of ARPA-H is still controversial, it explores organizational models, project funding mechanisms, provides an ideal platform for innovative ideas, and makes critical investments in breakthrough technologies and widely applicable platforms, resources and solutions in medicine and health for the benefit of all patients. These investments are often not easily achieved through traditional basic research and commercial activities.
In June 2021, the Information Technology and Innovation Foundation, a U.S. technology think tank, released a report titled "Ensuring the Continued Competitiveness of U.S. Biopharmaceuticals," which recommended that to ensure U.S. global leadership in the biopharmaceutical field, a strong national biopharmaceutical competitiveness strategy should be developed, and more investment should be made in industry-university partnerships that focus on biomedical innovation. The NIH should increase its funding by at least $12 billion, to $50 billion a year.
Many countries have issued new strategic plans and continuously revised, promoted and improved their medium - and long-term strategic plans
In June 2019, Japan issued the "Integrated Innovation Strategy 2019" and officially launched the "Biostrategy 2019" in the annex, which is following the "Biotechnology Strategy Outline" (2002) and "Fundamental Strengthening Measures to Promote Biotechnology Innovation" (2008) strategies, reconfirming the strategic position of biotechnology. The strategy integrates the "medical and non-medical fields" together for comprehensive consideration, focusing on the development of high-performance biomaterials, bioplastics, biological drugs, biological manufacturing systems and other fields, and the key funding. At the same time, important measures are also put forward in the aspects of biological resource bank, biological data science and technology facilities, and biotechnology talents.
The Russian Federation's Plan for the Development of Genetic Technologies for 2019-2027 is aimed at accelerating the development of genetic technologies such as gene editing, creating scientific and technological reserves for medicine, agriculture and industry, and monitoring and preventing biological emergencies. South Korea released the Biohealth Industry Innovation Strategy to promote the development of innovative drugs, medical devices and medical technologies, and promote the export growth of the biohealth industry. The UK has published the Biotechnology Sector Implementation Plan 2019 to develop cutting-edge biotechnology, address strategic challenges and strengthen the foundation for technological development. In 2021, France released the "French Health Innovation 2030 Strategy", which focuses on the creation of a large scientific research "cluster" and intends to use more than 4 billion euros of public funds for scientific research, aiming to re-establish France as a country of innovation in the field of medicine and health.
Pay more attention to domestic supply chain security
In the wake of the outbreak of COVID-19, countries around the world have increased their demand for biomedicine and faced shortages of drugs and medical supplies, and governments have actively taken measures to ensure the stability of supply chains.
The EU plans to update legislation to strengthen policy incentives and disciplinary measures to ensure the availability of medicines
In the early days of the COVID-19 pandemic, the EU faced difficulties in obtaining medicines and pharmaceutical ingredients from China and India, with the Commission estimating that two-thirds of the world's supply of apis was produced in India and China.
To address shortages caused by too few manufacturers, fragile supply chains, and insufficient financial incentives, the EU is considering stricter rules on the availability of medicines to ensure their availability. In response to the European Medicines Strategy, launched in November 2020, which includes strengthening crisis preparedness and response mechanisms, diversifying and securing supply chains, and addressing shortages of medicines among its four pillars, the European Commission is seeking more dialogue between drugmakers and regulators to come up with proposals aimed at addressing vulnerabilities in global supply chains. The EU plans to require pharmaceutical companies to develop contingency plans and accept stricter supply obligations from the level of research and development incentives and corporate fines. Eu Health Commissioner Stella Kyriakides told a meeting of health ministers in Slovenia, "We need to update legislation to address shortcomings in harmonized reporting, supply obligations and supply chain transparency." The Commission plans to propose legislation in December 2022.
The United States plans to increase domestic API manufacturing capacity
The White House report, led by the FDA and ASPR, notes that the U.S. pharmaceutical supply chain is increasingly dependent on foreign-made drugs, active pharmaceutical ingredients (apis), and key starting materials. The report also recommends promoting local production efforts in the United States and international cooperation to promote the establishment of innovative manufacturing processes and research and development of production technologies.
The White House, the U.S. Department of Health and Human Services (HHS), and the U.S. Food and Drug Administration (FDA) issued policy recommendations in June 2021 aimed at ensuring the safety of the U.S. drug supply chain, with HHS initially committing nearly $60 million to develop new platform technologies aimed at increasing domestic API manufacturing capabilities. To reduce dependence on the global drug supply chain.
Countries support the repatriation of API production
The COVID-19 epidemic has highlighted the importance of "raw materials are king", and many countries plan to restore the complete industrial chain in their own countries by moving the production of apis back to their home countries, in order to get rid of the import dependence on other countries' apis.
Countries such as the US, Europe, Japan and India have announced their intention to achieve local production of key medicines and medical products. For example, France's Sanofi will merge its six API manufacturing sites in Europe to create an independent API manufacturing company to balance Europe's dependence on Asian apis; In order to resist the huge impact on medical treatment caused by the shortage of antibiotics and other categories in Japan, Shionogi Pharmaceutical will start the production of surgical antibiotic raw materials in Iwate Prefecture as early as 2022. The Union Cabinet has approved a $1.3 billion stimulus package to focus on the production of 53 apis and key intermediates, and to fund the establishment of three apis parks in India.
Europe and the United States are clamping down on China's catch-up in biotechnology
In order to maintain its leading position in technology and science, the United States has systematically strengthened its support and protection in the field of biotechnology and continued to strengthen its suppression of Chinese biotechnology
The United States is comprehensively upgrading its competition with China at the forefront of science and technology in the form of legislation. In June 2021, the U.S. Senate passed the "American Innovation and Competition Act 2021" to open the era of systematic Chinese regulation through legislation, and the "Meeting the China Challenge Act 2021" is one of the six parts. The bill lists "biotechnology, medical technology, genomics and synthetic biology" as one of the ten key technical focus areas, and proposes to focus on protecting biomedical research areas, especially human genetic information.
In the past three years, the United States has strengthened its suppression of China from the level to maintain its leading position in the field of biotechnology. Restricting China's investment in biotechnology research and development in the US, imposing tariffs on more than 300 products in the biomedical field, banning biotechnology exports to China, including leading biotechnology companies on the "entity list", and canceling the "emergency use authorization" for COVID-19 testing reagents for Chinese enterprises.
Table 1: The suppression of China's biomedical sector by the United States
Source: Firestone Creation collated based on public information
The EU is also guarding against Chinese investment in special sectors such as biotechnology
In March 2020, the European Commission issued guidelines for the protection of important assets and technologies in Europe, including strategic industries such as health, medical research and biotechnology. In June, the European Commission issued a White paper on policies to prevent unfair competition, soliciting opinions on strengthening supervision of government subsidies to enterprises in third countries outside the EU, and further raising the threshold for Chinese enterprises to invest in Europe. At the same time, the United States and the European Union and other countries and organizations to establish a more diversified alliance on the basis of the original alliance, leveraging each other's advantages, joint containment of China's development, prevent China from surpassing the United States, December 2021,
Regulatory and approval cooperation to promote industrial innovation
Basic biomedical research, product development, marketing and acquisition and acquisition will continue to be carried out on a larger scale around the world, and pharmaceutical supply chain security, research and development and regulatory expertise cannot be achieved without multi-party cooperation. The regulatory regimes of mainstream countries will converge, especially in the areas of clinical trials, field verification and pharmacovigilance, where there will be more convergence of norms and information sharing and exchange will become more common.
Us and EU drug regulators strengthen information sharing to promote product development, and FDA and EMA launch pilot program for parallel scientific advice on complex generics and hybrid products
The U.S. FDA and the European Medicines Agency (EMA) announced in September 2021 the launch of a pilot program to provide parallel scientific advice (PSA) to applicants for Simplified New Drug Applications (ANDA) for complex generic products at the FDA and Marketing Authorization Applications (MAA) for mixed products at the EMA. The pilot program is an extension of an existing FDA and EMA new drug and biologic product PSA. The goal of the PSA pilot program is to provide FDA and EMA reviewers with a mechanism to optimize an applicant's global product development program, to exchange views with the applicant on scientific issues simultaneously during the development phase of complex generic/hybrid products, and to provide applicants with a deeper understanding of the basis for regulatory decision-making at both agencies. Help applicants avoid unnecessary research duplication or unnecessary diversification of testing methods and shorten the approval time.
The US, Europe, Canada, the UK and other regions have strengthened anti-monopoly cooperation in the pharmaceutical field to ensure drug supply and promote innovation
In March 2021, in response to the increasing number of mergers and acquisitions in the pharmaceutical sector, the European Commission said that it has established a dedicated working group that will work with its US and UK counterparts and share expertise on how to review mergers and acquisitions in the pharmaceutical industry, to conduct more rigorous scrutiny of mergers and acquisitions to prevent mergers and acquisitions from driving up drug prices and impeding innovation. The task force will take stock of the lessons learned in M&A in recent years and explore and promote competition and innovation in the industry.
Antitrust regulators in Europe and the US have gradually stepped up their scrutiny of pharmaceutical mergers and other practices that could harm consumers and competition in recent years, often focusing on issues such as reverse payment agreements and drug lifetime patent strategies.
International China has strengthened the internationalization of drug regulation and cooperated with many countries
China's regulatory internationalization process has gradually accelerated, the State Food and Drug Administration has signed memorandums of understanding with a number of regional drug regulatory authorities, while promoting international exchange activities in drug supervision, and deepening cooperation in the field of medicine, medical devices and cosmetics supervision.
In September 2021, the opening ceremony of the "Belt and Road" National Drug Regulatory and Development Cooperation Seminar and the "Belt and Road" National Pharmaceutical Regulatory Cooperation and Industrial Development Seminar co-sponsored by the State Food and Drug Administration and the Ministry of Commerce was held in Beijing in a combination of online and offline, and officials and experts from health and drug regulatory agencies from 17 countries attended the seminar.
In September 2021, the 6th China-Asean Drug Cooperation Development Summit Forum co-sponsored by the National Food and Drug Administration and the People's Government of Guangxi Zhuang Autonomous Region opened in Fangchenggang, Guangxi. With the theme of "Strengthening the supervision of drugs and medical Devices, Creating the Development of the Industry with excellence and Wisdom", representatives from various countries had in-depth exchanges and discussions on the legal construction of drug regulation, deepening the reform of the review and approval system, and combating the COVID-19 epidemic.
In June 2021, the launch meeting of the UK-China Drug Regulatory Cooperation Project was held in the form of video, and the 2021 UK-China drug Regulatory Cooperation Project plan was adopted, and it is planned to carry out technical exchange activities in the fields of drug evaluation, inspection and post-market monitoring to further enhance understanding and deepen cooperation. Chinese and British drug regulators signed a Memorandum of Understanding on cooperation in Drugs and Medical Devices in January 2018.
In April 2021, China's National Medical Products Administration held a bilateral meeting with Japanese drug regulators to conduct in-depth exchanges on bilateral regulatory cooperation between China and Japan. Regulators of China and Japan have conducted thematic reports and heated discussions on hot issues such as the revision of the Drug Administration Law, clinical trial management, real-world data application, and post-marketing supervision of drugs at the "2020 China-Japan Medical and Health Exchange Meeting".
Affected by the COVID-19 epidemic, all countries will pay more attention to the development of science and technology in the field of public health, and the field of life and health will become a key and core area of global scientific and technological innovation. Countries will further strengthen relevant basic research, enhance their capacity to tackle key and core technologies in medical and health care, and increase their strategic scientific and technological reserves for disease prevention and control and public health. The scientific and technological strategic competition of life and health technology will be further intensified, but at the same time, countries will further strengthen regulatory cooperation and serve the global cooperation of the pharmaceutical and health industry.