The protection of the right to health is particularly important. The patent system encourages the innovation and research and development of drugs, but the high price and market monopoly caused by the drug patent will prevent the patients from getting urgently needed drugs in time and fully, seriously threaten public health and aggravate the public financial burden of the government. In April 3, 2018, the general office of the State Council issued an opinion on the reform and improvement of the policy of the supply and use of generic drugs (20), and put forward “a clear route for the enforcement of compulsory licensing of drug patents”, pointing out that “the epidemic of major infectious diseases in the country and his public health incidents or serious prevention and treatment are serious in the country.” When there is a shortage of disease drugs and serious threats to public health or public health, compulsory licensing can be implemented in order to maintain public health. This article introduces the recent compulsory licensing action taken by Malaysia to Gilead’s Sofosbuvir, hoping to provide a reference for the maintenance of public health and the availability of drug availability in China.
When it comes to compulsory licensing for drug patents, commonly known as “forced imitation”, Malaysia is the first country in Asia to try tomato. The tension between patent protection and accessibility of drugs has become increasingly prominent since the entry into force of the WTO (TRIPS) in 1995. In November 2001, the fourth WTO ministerial conference, in Doha, capital of Qatar, adopted the Doha Declaration on Doha and public health (“the Doha declaration”), which recognizes that public health problems seriously affect many developing countries and the least developed countries, especially those plagued by AIDS, tuberculosis, malaria and other infectious diseases. The state reiterates that WTO members make full use of the flexibility provisions in the TRIPS agreement, including patent compulsory licensing, to promote the rights of drugs to and maintain 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 gave a two year import authorization to a pharmaceutical factory in its own country, allowing it to import three antiretroviral generics from India for the treatment of AIDS patients in the country, namely, D Idanosine) and GlaxoSmithKline’s Zidovudine and Lamivudine, which reduces the domestic drug price by 81%. Earlier, the Ministry of health in Malaysia tried to negotiate the price of anti AIDS drugs with the two pharmaceutical companies, but failed. After the enforcement of compulsory licensing, the prices of other first-line and second-line antiretroviral drugs have also declined significantly.
The main legal basis for Malaysia to make this compulsory license is the “government right” of its eighty-fourth (1) patent law. According to the article, the government or third party may use compulsory license to implement the related patent technology without the consent of the patenholder if there is a state emergency, or the need of public interest or the existence of anti competitive action by law. This provision is the Malaysia’s flexibility in implementing the “Doha declaration” and the TRIPS agreement on the “compulsory license” in the domestic law.
In September 20, 2017, the government of Malaysia made second more historic decisions, as well as under article eighty-fourth (1). The cabinet approved the exercise of government rights and compulsory license for the direct effect of the disease drug Sofosbuvir on the production of Gilead, in order to import 400 mg Sofosbuvir tablets from Egypt for the needs of the patients in public hospitals. This is the first case of forcible imitation of Sofosbuvir.
Sofosbuvir is a direct acting antiviral drug developed by Gilead company for the treatment of chronic hepatitis C. Its birth saved the hepatitis C patients who had only been treated with interferon and had to endure great side effects. It created a pure oral cure for hepatitis C and brought hope to many patients with hepatitis C in the world. On 6 December 2013, FDA was approved by the United States and approved to be listed in the United States and approved by the European Drug Administration (EMA) on the market on January 2014. In September 22, 2017, the State Administration of Drug Administration (former State Administration of food and Drug Administration) approved its listing in China.
When Sofosbuvir was first launched in the United States, it was priced at $84000 for a course of 12 weeks, or 1000 dollars per tablet (67 times the price of gold). In 2014, gilly, with Sofosbuvir and hepatitis C cocktail Harvoni (Sofosbuvir/ redI paway, known as the Ji two generation), received $17 billion 975 million in prescription drug sales, the top of the year’s list of global pharmaceutical giants.
There are about 500 thousand hepatitis C patients in Malaysia, about 2000 new cases each year. The main type of HCV is type 3. The best treatment for type 3 hepatitis C is Sofosbuvir and the combination of the Sofosbuvir/Velpatasvir (Sofosbuvir/Velpatasvir, commonly known as the Kyrgyzstan) and the Sofosbuvir and the Dhaka tamivir combination (Sofosbuvir/Daclatasvir, commonly known as the European Union). Malaysia’s own pharmaceutical factories do not have the ability to produce direct antiviral drugs, and can only rely on imports. Dhaka’s Tamai is produced by Bristol Myers Squibb, but it has no patent protection in Malaysia. The Malaysia State Drug Administration rejected the application of data protection by Bristol Myers Squibb in early 2017 on the grounds of public health. Therefore, Dhaka’s tamivi can be imported once approved in Malaysia. In Malaysia, Gilead has a patent for Sofosbuvir’s important compounds (expired in 2024) and a patent for pro drugs (expired in 2028). The drug regulatory agency in Malaysia has also given its 5 year data protection period (due from the first date of the world’s first country to be listed, expiring in December 6, 2018).
The high price of Sofosbuvir makes many countries sigh for drugs, and even some middle and high income countries are overwhelmed. Patients, non-governmental organizations and government public health departments expressed concern and dissatisfaction. In 2014, Gilead reached an imitation agreement with 11 India generic pharmaceutical factories (the patent voluntary licensing agreement), which agreed to produce and provide a copy of the copy of the liver in 91 developing countries, including the Sofosbuvir, Sofosbuvir/ repawpai and the Sofosbuvir/ pattamivir, after which the agreement was expanded. The exhibition covers 101 countries. The Sofosbuvir generic drug produced by the India pharmaceutical factory authorized by the generic protocol is priced at only 12 weeks, 66 dollars in India. However, Malaysia, Thailand, China, Brazil and South Africa, which have a large number of hepatitis C patients, are excluded from the countries covered by the generic agreement.
In Malaysia, the cost of using Sofosbuvir is about 24 weeks, 87430 dollars. In the past few years, the government of Malaysia has been asking Gilead to include it in the list of countries on the hepatitis C treatment protocol. At the same time, the Ministry of health held several rounds of price negotiations with Gilead, and Gilead agreed to give an offer of $12000 for 12 weeks, but the Ministry of health rejected the offer.
At the same time, the Drugs for Neglected Diseases Initiative (DNDi), a non-profit organization for drug research and development, cooperates with the clinical trials of hepatitis C therapy in Malaysia and Thailand. At the end of 2016, the Malaysia government conducted a clinical trial of the Sofosbuvir and Laverde Vee (Sofosbuvir/Ravidasvir) combination to identify this new combination as a pan genetic therapy, that is, to treat all genotypes of HCV infection, and with the current gene 3 therapy program Sofosbuvir and the Dhaka tamivir combination (Sofo Sbuvir/Daclatasvir) comparison.
To carry out this clinical trial, Malaysia needs to import Sofosbuvir and Laverde Vee. Sofosbuvir has no patent protection in Egypt. In accordance with the provisions of article thirty-seventh (1) of the Malaysia patent law, Malaysia’s import of Pharco from Egypt for this clinical trial is an exception to the scientific research. In addition, as DNDi obtained Laverde Vee’s non exclusive voluntary permission from the American pharmaceutical factory Presidio, Pharco was designated to produce La Vida, and Malaysia designated the native pharmaceutical factory Pharmaniaga for clinical trials of the Egyptian imported La Vida generic drugs. The price of the new combination is about 12 weeks and 300 dollars, which is in line with the target price of the Ministry of health of Malaysia. According to the news published by DNDi at the International Liver Disease Conference in Paris in April this year, the clinical trials of the combination of Sofosbuvir and Laverde Vee were good, with a cure rate of 97%.
Over the past two years, with the support of a number of international drug accessibility agencies, civil and patient groups in Malaysia have been actively calling for the reduction of Sofosbuvir prices. Government departments also discuss with domestic and foreign experts on how to obtain new hepatitis C treatment solutions at affordable prices. Compulsory licensing is also being discussed. On the list. Gilead also heard about it. In August 23, 2017, Gilead announced through its tweet official account that Malaysia, Thailand, Ukraine and Belarus would be included in the country of its imitation agreement. Even so, the government of Malaysia, considering more and more, decided to enact compulsory licensing decisions to import Sofosbuvir generics from Egypt, because the price of Sofosbuvir generic drugs was still higher than expected from a limited number of India generics. The Sofosbuvir generic drug, which is decided to import according to the compulsory license, will be used in the treatment needs of patients in Malaysia public hospitals.
“The government’s health minister said:” it is hoped that the implementation of the government’s rights will enable more patients with hepatitis C to be treated and reduce the cost of treatment for the complications caused by hepatitis C. ” After the promulgation of compulsory licensing, there will be a coexistence of voluntary and compulsory licensing for Sofosbuvir in Malaysia. Under Gilead’s imitation agreement, Malaysia can be imported from India for the treatment of hepatitis C (Sofosbuvir, Sofosbuvir/ repavin, Sofosbuvir/ vampivir) for patients in public hospitals and private hospitals; under compulsory licensing, only public hospitals can use Sofosbuvir generics imported from Egypt. In addition, Dhaka has no patent rights and can be imported after approval. By March of this year, all public hospitals in all the state governments had purchased Sofosbuvir and Dhaka, which were used to meet the needs of hepatitis C patients.
In addition to Malaysia, other countries, such as Chile and Columbia, are also considering whether to use compulsory licenses to Sofosbuvir to solve the problem of excessive drug prices affecting their accessibility and thus endangering public health.