The world's first case of imitation of "Soofibu"

The world's first case of imitation of "Soofibu"

April 27, 2018 Source: Medical Rubik's Cube Data

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Drugs are particularly important for the protection of the right to health. The patent system encourages innovation and research and development of drugs. However, the high prices and market monopolies caused by drug patents can prevent patients from obtaining urgently needed drugs in a timely and sufficient manner, seriously threatening public health, and aggravating the public. Financial burden. On April 3, 2018, the General Office of the State Council issued the "Opinions on Reforming and Improving the Policy of Supply and Use of Generic Drugs" (China Development Office [2018] No. 20), proposing "clearing the compulsory licensing path for drug patents" and pointing out that In the event of a serious outbreak of infectious diseases and other public health emergencies in the country, or a shortage of drugs for the prevention and treatment of major diseases, and serious threats to public health or public health, compulsory licenses may be implemented to maintain public health. This article describes Malaysia's recent compulsory licensing action against Sophos star drug Sofosbuvir developed by Gilead, and hopes to provide reference for China's efforts to maintain public health and promote access to medicines.

When it comes to compulsory licensing of pharmaceutical patents, which is commonly referred to as “strong imitation”, Malaysia is the first country in Asia to eat crabs. The tension between patent protection and access to medicines has become increasingly prominent after the entry into force of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995. In November 2001, the Fourth Ministerial Conference of the WTO adopted the Doha Declaration on TRIPS and Public Health (Doha Declaration) in Doha, Qatar. It recognized that public health issues have a serious impact on many developing and least developed countries, especially Those countries suffering from AIDS, tuberculosis, malaria and other infectious diseases have reiterated that WTO members make full use of the flexibility provisions of the TRIPS Agreement, including patent compulsory licenses, to promote access to medicines and to safeguard public health.

In November 2003, two years after the adoption of the Doha Declaration, the Ministry of Domestic Trade Cooperation and Consumer Affairs of Malaysia granted a two-year import authorization to a pharmaceutical company in the country, allowing it to import three antiretroviral imitations from India. The drug is used in the treatment of AIDS patients in the country, namely, Didanosine of Bristol-Myers Squibb and Zidovudine and Lamivudine of GlaxoSmithKline, which makes it a domestic drug. The price is reduced by 81%. Earlier, the Malaysian Ministry of Health also tried to negotiate with the two pharmaceutical companies for the price of anti-AIDS drugs, but none of them succeeded. After the compulsory license was implemented, the prices of other first- and second-line antiretroviral drugs also dropped significantly. [1]

The main legal basis for Malaysia’s decision to make this compulsory license is the “government rights” under section 84(1) of its Patent Law. According to the provisions of this article, if a state of emergency occurs, or if the public interest requires, or if there is anti-competitive behavior as determined by law, the government or a third party may (apply) use the compulsory license to implement the relevant patent technology without the consent of the patentee. This provision is Malaysia's flexibility in implementing the Doha Declaration and the TRIPS Agreement on “Compulsory Licensing” in domestic law.

On September 20, 2017, the Malaysian government made another second historic decision. According to Article 84(1), the Cabinet approved the exercise of government rights to enforce the direct effect of the antiviral drug Sofibuvir on Gilead's production. Permitted to import 400 mg of sofosbuvir tablets from Egypt for patient needs in public hospitals. [2] This is the first case of the imitation of Sophie.

Sofabru is a direct-acting antiviral drug developed by Gilead for the treatment of chronic hepatitis C. Its birth has saved the hepatitis C patients who can only be treated with interferon and have to endure great side effects. It has created the era of oral cure of hepatitis C, which has brought hope to many patients with hepatitis C in the world. It was approved by the US FDA on December 6, 2013 and listed in the US on January 16, 2014. It was approved by the European Medicines Agency (EMA) for listing in the European Union. On September 22, 2017, the State Drug Administration (formerly National Food and Drug Administration) The State Administration of Supervision and Administration approves its listing in China.

When Sophibway was first launched in the US, it was priced at $84,000 for a 12-week course of treatment, or $1,000 per piece (67 times the price of gold in grams). In 2014, Gilead received $17.975 billion in prescription drug sales with Sofbwe and Hepat Cocktail Harvoni (Sophie Bway/Redipal, commonly known as Kyrgyz II), ranking first in the global pharmaceutical giants' income rankings.

There are approximately 500,000 hepatitis C patients in Malaysia, with approximately 2,000 new cases each year. Its hepatitis C patients are mainly genetic type 3. The best treatment for type 3 hepatitis C is the combination of sofosbuvir and vertapavir (Sofosbuvir/Velpatasvir, commonly known as the third generation) and the combination of sofosbuvir and dacavitavir (Sofosbuvir/Daclatasvir, commonly known as the European Union). Malaysian domestic pharmaceutical companies do not have the ability to produce direct-acting antiviral drugs and can only rely on imports. Dacartamine is produced and produced by Bristol-Myers Squibb, but it is not patent protected in Malaysia. The Malaysian National Drug Administration rejected the data protection application of Bristol-Myers Squibb in early 2017 on the grounds of public health. As a result, dacomevir generics can be imported once they are approved for sale in Malaysia. Gilead owns important compound patents (expired in 2024) and prodrug patents (expired in 2028) in Sombuwe in Malaysia. The Malaysian Drug Regulatory Authority also granted a five-year data protection period (from the date of approval of the first country in the world to be approved, due on December 6, 2018).

The high price of Sofibwe has made many countries look forward to the "drug" and even some middle- and high-income countries are overwhelmed. Patients, civil society organizations, and government public health departments have expressed concern and dissatisfaction. In 2014, Gilead reached a generic agreement with 11 generic drug factories in India (the patent voluntary license agreement), stipulating that these Indian pharmaceutical companies produce and supply generic drugs for the treatment of hepatitis C to 91 developing countries, including sofosbuvir. The combination of Sofibwe/Redipawi and Sofibwe/Vipavovir, which later expanded to 101 countries [3]. The sofbuvir generic drug produced by the Indian drug factory authorized by the imitation agreement is only sold for $66 in 12 weeks in India [4]. However, countries such as Malaysia, Thailand, China, Brazil, and South Africa, where the number of hepatitis C patients is high, are excluded from the countries covered by the imitation agreement.

In Malaysia, the cost of treatment with sofosbuvir is approximately $84,430 for 24 weeks [5]. In the past few years, the Malaysian government has been asking Gilead to include it in the list of countries where the hepatitis C treatment copying agreement has been unsuccessful. At the same time, the Ministry of Health and Gilead conducted several rounds of price negotiations, Gilead agreed to give a 12-week $12,000 offer, but the Ministry of Health rejected the offer.

At the same time, the Drugs for Neglected Diseases Initiative (DNDi, a non-profit organization engaged in drug discovery) has partnered with Malaysia and Thailand to begin clinical trials for hepatitis C treatment. At the end of 2016, the Malaysian government conducted a clinical trial of a combination of sofosbuvir and Ravidasvir, with the goal of confirming that this new combination is a pan-genotype treatment that can treat all genotypes of hepatitis C virus infection, and Comparison with the current genotype 3 treatment regimen, sofosbuvir and dactavitavir (Sofosbuvir/Daclatasvir). [6]

To carry out this clinical trial, Malaysia needs to import sofosbuvir and Ravidavir. Sofabwe has no patent protection in Egypt. According to Article 37(1) of the Malaysian Patent Law, Malaysia's import of sofosbuvir generics from Pharco in Egypt for this clinical trial is an exception to scientific research. In addition, since DNDi obtained a non-exclusive voluntary license from Ravi Davi from the US pharmaceutical company Presidio, Pharco was designated to produce Ravi Davi generic drugs, and Malaysia designated domestic pharmaceutical company Pharmaniaga imported Ravi Davi from Africa for clinical use. test. The price of this new combination is about $300 for 12 weeks, which is in line with the target price of the Malaysian Ministry of Health. According to the news released by DNDi at the International Liver Disease Conference held in Paris in April this year, the clinical trials of the combination of sofosbuvir and Ravidavir have been very effective, with a cure rate of 97%. [7]

Over the past two years, with the support of some international drug accessibility advocacy agencies, Malaysian civil society organizations and patient groups have been actively calling for lowering the price of Sofibuvir, and government departments are also discussing with domestic and foreign experts how to afford The price of the new hepatitis C treatment solution, the compulsory license is also discussed. In this regard, Gilead has also heard about it. On August 23, 2017, Gilead announced through its official Twitter account that Malaysia, Thailand, Ukraine and Belarus will be included in the country of its imitation agreement. Even so, the Malaysian government has decided to issue a compulsory licensing decision to import sofosbu generics from Egypt, because the generic drug is still imported from a limited number of Indian generics through a generic agreement. Higher than expected. The sofosbuvir generics imported under the compulsory license will be used for the treatment needs of patients in public hospitals in Malaysia.

The Minister of Health of Malaysia said: “I hope that the implementation of government rights will enable more patients with hepatitis C to receive treatment and reduce the cost of treatment for complications caused by hepatitis C.” After the compulsory license decision is issued, there will be voluntary permission for Sofibuway in Malaysia. A situation where coexistence with compulsory licenses. Under Gilead’s imitation agreement, Malaysia’s generic drugs for the treatment of hepatitis C (soffib, sofosbuvir, redipavir, sofosbuvir/vepavir) are used in public hospitals and Treatment of patients in private hospitals; under compulsory licensing, only public hospitals can use the generics of sofosbuvir imported from Egypt. In addition, Dacacetin has no patent rights and can be imported after being approved for listing. By March of this year, all public hospitals in the state governments had purchased sofosbuvir and dacataxa generic drugs to meet the needs of hepatitis C patients.

In addition to Malaysia, other countries (such as Chile and Colombia) are also considering whether to use compulsory licenses for Sofibwe to solve the problem of excessive drug prices affecting their access and thus endangering public health.

Reference materials:

[1] Chee Yoke Ling: Malaysia's Experience in Increasing Access to Antiretroviral Drugs: Exercising the “Government Use” option, Third World Network.

[2]https://kpkesihatan.com/2017/09/20/press-statement-minister-of-health-20th-september-2017-implementation-of-the-rights-of-government-for-sofosbuvir-tablet -to-increase-access-for-hepatitis-c-treatment-in-malaysia/

[3] Gilead: Chronic Hepatitis C Treatment Expansion Generic Manufacturing for Developing Countries, http://?la =en

[4] MSF: Not Even Close, https://msfaccess.org/our-work/hepatitis-c/article/2847

[5] http://

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