The first Model United Nations Conference of Hefei No. 1 Middle School was held!
Roche authorizes a Chinese company to produce Tamiflu, which has a huge public relations effect
〔Author: Reprinted from: Internet Clicks: 258 Update Time: 2005-12-16〕
Roche authorized Shanghai Pharmaceuticals Group to be the first in the world to produce Tamiflu, gaining not only market and profits, but also a huge public relations effect
On December 12, local time, it owned the patent for Tamiflu anti-influenza drug The Swiss pharmaceutical group Roche Holding AG issued a statement in Basel, Switzerland, announcing that it has authorized China's Shanghai Pharmaceutical Group to carry out the full production of Tamiflu (Tamiflu, also known as "Tamiflu" and "Cflu"). It also announced that It has selected 12 additional potential regional partners for production to increase global production capacity. Shanghai Pharmaceuticals Group thus became the first foreign pharmaceutical company in the world authorized to produce Tamiflu.
According to statements from Shanghai Pharmaceuticals Group and Roche, Shanghai Pharmaceuticals Group has been officially authorized to manufacture and sell oseltamivir raw materials and preparations in China except Hong Kong, Macao and Taiwan. The licensing agreement between the two companies stipulates that in the event of an influenza outbreak, Shanghai Pharmaceuticals Group can produce oseltamivir to meet government procurement. The trade name of oseltamivir is "Tamiflu", but since "Tamiflu" is a special trade name registered by Roche in China, the name "Tamiflu" will not be used for oseltamivir produced by Shanghai Pharmaceuticals in the future.
Both public relations and market value are evident
On December 1, China’s Minister of Health Gao Qiang pointed out at a press conference in Beijing when talking about the negotiations between Shanghai Pharmaceuticals Group and Roche: It is hoped that Tamiflu will be produced in China through technology transfer. Less than half a month later, a Chinese company was the first to obtain authorization to produce Tamiflu. This is related to China’s potential huge demand and is also inseparable from Roche’s focus on the entire Chinese pharmaceutical market.
In mid-November, Switzerland's local "Daily Herald" reported that in view of the rapid development of China's western medicine market, Swiss pharmaceutical giants have focused on China as a development focus; in 2004, Roche's investment in China reached 1.9 billion Swiss francs (1 US dollar equals approximately 1.3 Swiss francs); starting from 2006, Roche's new pharmaceutical factory in Shanghai will be able to produce valuable drugs worth 22 million Swiss francs annually; Roche's Shanghai research center has applied for its first patent ; Roche plans to increase the number of employees in China from 40 to 200 or 250 next year. Swiss pharmaceutical companies concluded that "China's pharmaceutical market will be a long-term market for developing countries" - the world's first overseas Tamiflu production authorization was launched in a long-term development market like China, which is very concerned about this drug. The public relations role can be imagined.
Making Tamiflu in China has raw material advantages. Our reporter in Geneva, Li Jie, called Roche to confirm that the raw materials used to produce Tamiflu contain star anise. On November 9, when Roche briefed the outside world on the ingredients and production process of Tamiflu, it explained in detail: 2/3 of the shikimic acid required to make Tamiflu comes from star anise. It takes 30 kilograms of star anise to process 1 kilogram of shikimic acid, and every 6 grams of shikimic acid can produce 1 Tamiflu. Star anise is mainly produced in China and Vietnam. China has abundant star anise raw materials and is exported in large quantities. From January to October this year, Guangdong ports exported 1,649 tons of star anise, worth US$2.86 million. The supply of star anise is not a problem, but for Tamiflu, which is out of stock in many markets, obtaining raw materials nearby is beneficial to speed up production and squeeze the market.
It is reported that Roche’s license fees will be determined based on sales, and Shanghai Pharmaceuticals Group stated that the products it produces will have price advantages. Shanghai Pharmaceuticals estimates that it will be able to produce 200,000 doses per month by the middle of next year - so there is no doubt that Roche will profit from China's production of Tamiflu.
Global pharmaceutical companies are anxiously queuing up
Regarding the cooperation between Roche and Shanghai Pharmaceuticals, the French Agence France-Presse reported on the 12th that "Roche and China have reached a Tamiflu deal, and other partners are queuing up." headline reported. For some time, Roche has been criticized for its reluctance to disclose the formula of Tamiflu or authorize others to produce it. Roche's release of authorization has attracted the attention of global pharmaceutical companies.
Roche said it has selected 12 partners from 200 applicants interested in producing Tamiflu. The company did not identify the manufacturers, but said the partners include major pharmaceutical manufacturers, large generics manufacturers and specialty chemical manufacturers.
These 12 companies have been invited to conduct further in-depth negotiations with Roche. "We are not yet sure who will be able to put it into production quickly in the first half of 2006, but we can be sure which partners can guarantee that there will be no shortages or help expand geographical coverage," said William B., CEO of Roche's pharmaceutical division. Enns said. According to US Senator Charles Schumer on December 8, Roche is negotiating with Teva of Israel and Mylan of the United States. Roche had allowed Schumer to make similar announcements, in part because Schumer had been urging the company to approve generic manufacturers of the drug.
“The companies we have identified will further expand their production capacity and thus enable Roche’s supply network to meet the future needs of governments around the world,” said David Reddy, head of Roche’s pandemic task force. Roche claimed that the expanded production capacity can meet orders from about 50 countries, regional governments and the World Health Organization. Roche will donate 3 million doses of Tamiflu to the World Health Organization as a reserve for epidemic centers when quickly limiting and slowing down the possible spread of the epidemic. This production capacity will be gradually established starting from the middle of 2006, and priority will be given to meeting the needs of South Korea and Malaysia.
It is reported that Roche has agreed to freely produce their own versions of Tamiflu in Thailand, the Philippines and Indonesia, which have no drug patent restrictions. It will also provide basic ingredients to manufacturers in Vietnam and India and package them locally.
According to Article 39, paragraph 3, of the TRIPS Agreement, member states should protect all data that meets the following five conditions:
The data is submitted for the purpose of obtaining market authorization for products in that member state. ; the product seeking market authorization is a pharmaceutical
or an agricultural chemical product; the product seeking market authorization contains new chemical ingredients; the data has not been disclosed before
is submitted; the data The research and development requires considerable effort. Among them, terms such as "new chemical composition" and "un
unfair commercial use" are relatively vague, and the issue of exclusivity is not directly mentioned. Therefore, countries
This definition has also given rise to different understandings. For example, in the United States, Japan and most Western European countries, people generally believe that data protection and data exclusivity are completely equivalent. The various member states of TRIPS also have very different regulations on data protection years, ranging from 5 to 15 years. The protection period in most countries is 5 years. Many countries, including
China, Egypt, South Africa and Saudi Arabia, have enacted relevant regulations, while many, including
Argentina, Cuba, Indonesia, the Philippines and India Developing countries have not yet made clear provisions on this
.
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Changes in the market structure and the rise of emerging markets
Over the years, the world’s pharmaceutical market has been concentrated in the United States, Europe, Japan and other places, these developed countries account for 80% of the global pharmaceutical market. However, in recent years, the market share of these countries has been on a downward trend, and the emerging markets known as the "E7 Group" (Brazil, China, India, Indonesia, Mexico, Russia and Turkey) have emerged among global pharmaceutical companies and have strong growth momentum. , its share in the global pharmaceutical market is expected to increase from 8% in 2006 to 16% in 2011.
It is predicted that in the growth of the global pharmaceutical market, the contribution rate of the seven major pharmaceutical markets in 2008 will be less than 50% for the first time, while the contribution rate of the seven emerging markets will be close to 25% for the first time. The total market size of "E7 Group" will increase by 12% to 13% in 2008, reaching 85 billion to 90 billion US dollars, which contains great business opportunities.
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Many developing countries including Indonesia, the Philippines and India have not yet made clear stipulation. Data protection and drug patent patent The issue of data exclusivity is often related to pharmaceuticals... In the past, developing countries have been advocated against the patent system, but with the rise of the domestic pharmaceutical industry and taking into account foreign companies' concerns about India's intellectual property rights, the Indian government's position is... p>
Mint, as an authentic Chinese medicinal material, currently has 8 patents in the hands of Americans. A Japanese company has also applied for patents in the United States for Angelica and Peony Decoction, Shaoyao and Licorice Decoction, etc., and clearly stated that peony is Active ingredients. This means that if relevant Chinese patent medicines from my country are exported to the United States, they are likely to be detained or high patent fees imposed in the name of infringement of intellectual property rights.
According to figures previously announced by the State Intellectual Property Office, Japan and South Korea have become absolute winners in the international market of Chinese herbal medicines, with varieties accounting for 80% to 90%, while Chinese preparations only account for 3%~5%.
It is worth noting that countries such as Indonesia have set their own traditional medicines as national confidentiality projects, and companies in other countries have no right to use them at will.
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China established a food safety cooperation mechanism with the Philippines and Indonesia
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China Food Industry Network (09:12, October 30, 2007)
China has established a food safety cooperation mechanism with the Philippines and Indonesia
On October 28, the General Administration of Quality Supervision, Inspection and Quarantine signed meeting minutes with relevant parties from the Philippines and Indonesia respectively, agreeing to establish a food safety cooperation mechanism to monitor incidents that occur in bilateral food trade. Quality and safety issues shall be reported promptly, actively negotiated, and properly resolved. Li Changjiang, director of the General Administration of Quality Supervision, Inspection and Quarantine, attended the signing ceremony, and Wei Chuanzhong, deputy director of the General Administration of Quality Supervision, Inspection and Quarantine, signed the minutes on behalf of China.
It is understood that during the first China-ASEAN Quality Inspection Ministers’ Meeting held in Nanning, the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China held bilateral consultations with the food safety authorities of some ASEAN countries to discuss issues of mutual concern such as the safety of imported and exported food. exchanged views on the issue.
In the minutes of the meeting signed with the Philippine Ministry of Health, China and the Philippines reviewed past cooperation in the field of food safety, especially the cooperation and latest progress in handling the incident of student discomfort in Cebu Province, Both parties agreed to continue cooperation to achieve a fair and proper resolution of this incident.
The minutes of the meeting stated that China and the Philippines exchanged views on the issue of formaldehyde residues in food. China hopes that the Philippines will take a scientific look at the issue of formaldehyde residues in food. The Philippines said it is conducting assessment and research on this issue and will adjust relevant policies based on the assessment results.
In the minutes of the meeting signed with the Indonesian Food and Drug Administration, both parties pointed out that there are currently problems such as the lack of effective information exchange and sufficient technical cooperation in the cooperation. The two parties also exchanged views on the issue of formaldehyde residues in food and agreed to have technical experts conduct cooperative research on this issue.
In addition, the General Administration of Quality Supervision, Inspection and Quarantine also informed the Philippines and Indonesia of the recent series of measures taken by the Chinese government to ensure food safety.
In terms of food safety cooperation mechanisms, China and the Philippines and China and Indonesia have agreed to adopt this mechanism: First, timely notification and active consultation on quality and safety issues arising in bilateral food trade, and properly resolve them ; The second is to establish channels for exchanges, communication and mutual visits between managers and technical experts of both parties; the third is to timely exchange the laws, regulations, standards, inspection procedures, methods and their latest changes involving the inspection and supervision of imported food between the two parties. The fourth is to timely report relevant information about imported and exported food, and jointly crack down on illegal import and export of food.
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The Minister of Commerce and Industry of India issued a statement on the issue of Dorha negotiations. p>
Indian Minister of Commerce and Industry Nath issued a statement on May 16, saying that major trading countries such as the United States and the European Union should show "leadership" in the current Doha negotiations instead of taking all responsibility for the success of the negotiations. in developing countries.
Nutter said in the statement that whether the Doha negotiations can be concluded before the end of 2008 depends on many factors. The most important of these is whether the member states that have enjoyed the most fruits of trade liberalization are willing to contribute to achieving the goal of the Doha negotiations - "development." If the Doha negotiations fail to fulfill their development commitments and become another round of market access that serves rich countries, then the current efforts of the vast number of developing countries, including India, will be unlikely to succeed.
As for agriculture, Nath said that the first priority for India is to ensure the livelihood of poor and vulnerable farmers. Therefore, the issues of special commodities and special safeguard measures must be resolved first. He criticized the United States and the Keynes Group for requiring developing countries to provide a list of special commodities on the grounds of transparency, but refused to provide their own sensitive commodity lists. He said that the G33's three standards for special commodities, namely livelihood security, rural development and food security, could Meet transparency requirements.
Regarding the negotiation of rules, Nutt said in a statement that proposals regarding anti-dumping and fishery subsidies have been strongly criticized by many countries. Proposals for fisheries subsidies would threaten the livelihoods of millions of fishermen in India. In this regard, India, China, and Indonesia recently put forward a new proposal, which should be seriously considered by relevant parties. Regarding anti-dumping, he said that some people are trying to please a certain country through text, but the ruling of the WTO Appellate Body in the "Return to Zero" case shows that such efforts are untenable. He stressed that India and many developing countries will not support the end of agricultural and non-agricultural negotiations if the text on anti-dumping and fishery subsidies is not revised.
As for services, the statement stated that market access in Modes 1 and 4 is very important for the balance of "gains and losses" for India and some developing countries, and the current service trade negotiations focus on those that mainly involve the interests of developed countries. Mode 3.
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Almost.