HONG KONG (Reuters) - China has overhauled parts of its intellectual property laws to allow its drug makers to make cheap copies of medicines still under patent protection in an initiative likely to unnerve foreign pharmaceutical companies.

The Chinese move, outlined in documents posted on its patent law office website, comes within months of a similar move by India to effectively end the monopoly on an expensive cancer drug made by Bayer AG by issuing its first so-called "compulsory license".

The action by China will ring alarm bells in Big Pharma, since the country is a vital growth market at a time when sales in Western countries are flagging.

The amended Chinese patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

For "reasons of public health", eligible drug makers can also ask to export these medicines to other countries, including members of the World Trade Organisation.

Compulsory licenses are available to nations to issue under WTO rules in certain cases where life-saving treatments are unaffordable.

"The revised version of Measures for the Compulsory Licensing for Patent Implementation came into effect from May 1, 2012," China's State Intellectual Property Office said in a faxed statement to Reuters.

The changes can be found on the website of China's State Intellectual Property Office at http://link.reuters.com/tus68s

China is known to be looking at Gilead Sciences Inc's tenofovir, which is recommended by the World Health Organisation as part of a first-line cocktail treatment for AIDS patients, two sources with direct knowledge of the matter said.

China's generic drug makers were getting ready to produce tenofovir, they added.

At a drug access workshop hosted by the United Nations and health activists in Bangkok in early June, Chinese officials spoke of the changes to its patent law. Officials from Cambodia, India, Indonesia, Malaysia, Myanmar, the Philippines, Thailand and Vietnam also participated in the meeting.

"In May 2012, China created a change in their IPR (intellectual property rights) legislation to be able to issue compulsory licenses. China is considering further strengthening its legal framework, so as to make use of legal space to produce generic drugs," said Bob Verbruggen, senior adviser for the UNAIDS Asia Pacific office, who was present at the workshop.

"China's action plan at the workshop seemed to confirm that it intends to become a generic producer for the domestic and international market," he told Reuters by telephone.

CHINA PREPARED LONG AND HARD FOR THIS

China's move follows India's granting of a compulsory license in March to local generic drugs firm Natco Pharma to manufacture Bayer's cancer drug Nexavar, used for treating kidney and liver cancer.

However, China had signaled interest in the idea from at least 2008-2009, when its State Intellectual Property Office invited foreign experts to Beijing to show Chinese officials how to prepare the legal grounds for issuing compulsory licenses.

"They wanted to know the legal perspective ... They wanted to know about Thailand's IP Act that allowed us to make a CL (compulsory license) under the law for public interests, in an emergency," said Vithaya Kulsomboon, associate professor at Thailand's Chulalongkorn University, who was invited to Beijing at the time.

Kajal Bhardwaj, a legal expert from India who is working on health, HIV and human rights trade laws, said China's move was well within the limits of international trade agreements.

"CLs have previously been issued in the region by Malaysia, Indonesia, Thailand and India. CLs have also been issued on multiple occasions by developed countries including the U.S. and EU member countries," Bhardwaj said.

"It is very encouraging that China is seeking to ensure that this right ... is reflected in its legal regime on intellectual property," she added.

SABRE-RATTLING

China's stable of generic drug makers has been producing the key ingredients - or active pharmaceutical ingredients (APIs) - in medicines for years, exporting them to foreign drug makers, which then sell the patented finished products back to China at prices which the average Chinese citizen often cannot afford.

In particular, the government is struggling to provide newer HIV drugs, such as Gilead's tenofovir, known by its brand Viread and which had worldwide sales last year of $737.9 million.

China's government, initially slow to acknowledge the problem of HIV/AIDS in the 1990s, now admits to having a ballooning number of HIV/AIDS cases.

Although Gilead moved to share its intellectual property rights on its medicines in a patent pool with generic drug makers from many countries last July in return for a small royalty, China was excluded, which meant it had to continue paying high prices for tenofovir.

Since the change in China's patent law, Gilead has offered certain concessions, including giving China a substantial donation of tenofovir if it continues to buy the same amount, said Paul Cawthorne, coordinator for Medecins Sans Frontieres' Access Campaign in Asia.

"This is all a negotiation game; this offer from Gilead came about once the news that the Chinese was considering issuing a CL came out. The end game is okay, you get a better deal or you use the CL, it's a strategy that many countries use," he said.

Gilead in Hong Kong declined to comment. No one was immediately available to comment at its head office in California.

All eyes are now trained on how China battles it out with big foreign drug exporters, especially from 2013 when the Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria will no longer give grants to China to fight HIV.

Web link: http://money.msn.com/business-news/article.aspx?feed=OBR&date=20120608&id=15203540

Asia-Pacific countries called for accelerating the legal construction of armed forces' participation in disaster relief, saying that current international laws are still too incomplete to jointly counter the major natural challenges.

With an efficient command system, fast mobility and outstanding capability, the armed forces play an irreplaceable role in responding to natural disasters, which is still the direct threat to people's life, Rear Admiral Li Ji, deputy chief of the Foreign Affairs Office, China's Defense Ministry, said on Monday.

However, "the international laws relating to disaster relief are incomplete. All these factors constrain the participation in international disaster relief by armed forces", he said.

Li made the remarks while attending the third Association of Southeast Asian Nations Regional Forum Seminar on Laws and Regulations on the Participation in International Disaster Relief by Armed Forces in Beijing, which was co-chaired by China, Indonesia and the United States.

The seminar is being held to further study the laws and regulations on the participation in international disaster relief by armed forces. Around 80 representatives from the three countries, other ASEAN Regional Forum members and International Committee of the Red Cross attended the seminar.

The number and diversity of international actions for disaster relief have been increasing, while national legal and regulatory systems are not yet set up to deal with an influx of international assistance in an efficient and effective manner, said William Dwyer, commander of US Coast Guard.

For instance, he said, arcane customs regulations can make rapid importation of humanitarian supplies difficult.

Conflicts may arise between the affected countries and assisting countries on issues such as the protection of affected countries' sovereignty, assisting countries' access and mobility and authority of commanding, said Senior Colonel Wang Mei, a professor with the National Defense University of People's Liberation Army.

Web link: http://www.chinadaily.com.cn/china/2012-06/11/content_15494128.htm

The government on Thursday began to solicit public opinion on proposed changes to a 12-year-old law on the administration of Internet service in China.

The Measures on the Administration of Internet Information Services, enacted in 2000, have become outdated in many aspects due to the rapid development of the Internet and the emergence of new technology and applications, said a joint statement issued by the State Internet Information Office and the Ministry of Industry and Information Technology.

The draft amendment to the law aims to improve the administration and orderly development of Internet information services, as well as to maintain national security, and the legitimate rights and interests of the public and Internet information service providers, according to the statement.

The draft encourages service providers to launch self-discipline activities and the public to supervise Internet information services.

If the draft becomes law, an Internet supervision system will be established mainly compromised of Internet information content administrative authorities, telecommunication authorities and police authorities.

The draft also clarifies the licensing procedure for online forums and micro blog sites, and standardizes the entry criteria for websites and the management responsibilities of service providers.

More rules will be laid down for the real-name registration of users if it is passed.

Members of the public are invited to offer their opinions on the draft amendment before July 6 by logging on to www.scio.gov.cn, www.miit.gov.cn and www.chinalaw.gov.cn.

Web link: http://usa.chinadaily.com.cn/epaper/2012-06/08/content_15486982.htm

China has amended its intellectual property laws in order to allow the government to issue compulsory licenses for local generics makers to produce drugs which are still in patent.

The State Intellectual Property Office (SIPO) has reported that a revised version of Measures for the Compulsory Licensing for Patent Implementation took effect on May 1, allowing officials to issue compulsory licenses (CL) to local firms in cases of state emergencies, unusual circumstances or in the interests of the public.

The moves also permits domestic firms which receive the licenses to be able to apply for permission to export their versions of the patented drugs, for "reasons of public health."

According to Reuters, China is looking in particular at Gilead Sciences' Viread (tenofovir), a critical drug used in a combination first-line HIV treatment which is recommended by the World Health Organisation (WHO).

Last July, Gilead became the first drug maker to sign up for the Medicines Patent Pool, which was established in 2010 by UNITAID to improve access to HIV/AIDS and hepatitis drugs in developing countries. The agreement allows for the production of generic versions of Viread - on payment of a small royalty to Gilead - for supply to 111 countries, but not China.

Moreover, the Global Fund to Fight AIDS, Tuberculosis and Malaria is set to end its HIV/AIDS drug funding for China next year.

Reuters also quotes Paul Cawthorne of international aid agency Medecins Sans Frontieres as noting that, since China amended its patent laws, Gilead has offered the country certain concessions relating to the supply of Viread, including donating a sizeable amount of the drug if the government continues buying it in the same quantities. "The end game is OK - you get a better deal or you use the CL, it's a strategy that many countries use," he commented.

China's patent law amendments follow a similar recent move by India, which in March granted the country's first CL, to local generics maker Natco, for Bayer's Nexavar (sorafenib), used in the treatment of liver and kidney cancers, after the German company "failed to ensure affordable access to the drug."

However, India's Patent Office limited the CL for domestic supply only, not export, and China's decision to allow the CL holders to apply for permission to export as well signals the country's ambitions for its generic drugs industry both domestically and on the international market, according to experts.

Web link: http://www.pharmatimes.com/Article/12-06-13/China_amends_patent_laws_to_enable_compulsory_licensing.aspx

The State Council Information Office unveiled the National Human Rights Action Plan (2012-2015) (hereinafter referred to as the Action Plan) on June 11, drawing wide attention, both domestically and internationally. Wang Chen, director of the International Communication Office of the Communist Party of China (CPC) Central Committee and head of the State Council Information Office, answered questions concerning China's formulation of the Action Plan in an exclusive interview with Xinhua News Agency. The following is the translated version of the full text of the interview: 

Xinhua: 

The Chinese government introduced the National Human Rights Action Plan (2009-2010) in 2009, and has now unveiled the National Human Rights Action Plan (2012-2015). Why is the formulation of the second Action Plan important?

Wang Chen: 

Ensuring and enjoying human rights in the broadest sense is a lofty ideal and goal that the Chinese government and people have unswervingly pursued. Respecting and safeguarding human rights is one of this country's constitutional principles and an important guideline of governance for the Chinese government. 

The first National Human Rights Action Plan that the Chinese government introduced in 2009 has substantially facilitated the development of the cause of human rights in China, and has been widely acclaimed by the Chinese people and widely praised by the international community. The 2012-2015 period is crucial in terms of implementing the 12th Five-Year Plan for the National Economic and Social Development, deepening reform and opening-up, accelerating the transformation of the economic growth pattern and breaking new ground for scientific development; it is also an important period for enhancing human rights protection and realizing the all-round development of the cause of human rights. Building on the past experience gained in formulating and enforcing the first Action Plan, the Chinese government has formulated the second human rights action plan to specify its aims and tasks in terms of promoting and protecting human rights during the 2012-2015 period. 

The formulation of the Action Plan is greatly significant in terms of both consolidating the progress and achievements made in the cause of human rights in China and for continuing to solve existing problems and tackle new challenges; it is of great significance for further improving human rights protection measures in legislation, administration and judicial areas. It is also significant for propelling institutional and legislative protection of human rights, for further firming up the constitutional principle of respecting and safeguarding human rights, and for safeguarding citizens' economic, political, social and cultural rights; it also holds great significance for advancing scientific development and promoting social justice and harmony, for endeavoring to ensure that every member of society lives a more dignified and happier life and for striving to realize the goal of building a moderately prosperous society. 

The promulgation of the new National Human Rights Action Plan indicates the Chinese government's determination to further the cause of human rights in China in an all-round way, and also signals that the cause of human rights in China has entered a new stage, which is being advanced in a planned, steady and comprehensive fashion. 

Xinhua: 

The Action Plan covers China's various aspects including economy, politics, society and culture, and is closely related to the work of government departments. It has also attracted the attention of people from all walks of life. Would you please outline how the Action Plan was formulated? 

Wang Chen: 

The Action Plan involved the joint efforts of the relevant departments of the CPC Central Committee and the central government as well as the broad participation of all social sectors. It covers all aspects of Chinese life, including economy, politics, culture and society. In order to establish a good plan and to ensure the authority and effectiveness of the Action Plan, the Chinese government set up a joint meeting mechanism for the National Human Rights Action Plan. The State Council Information Office and the Ministry of Foreign Affairs, two members of the "joint meeting mechanism," took the responsibility of convening meetings. The mechanism included a further 54 departments of the CPC Central Committee and the State as well as people's organizations and non-governmental organizations. Members included: the General Office of the Standing Committee of the National People's Congress (NPC), the Commission for Legislative Affairs of the NPC Standing Committee, the General Office of the National Committee of the Chinese People's Political Consultative Conference (CPPCC), the Social and Legal Affairs Committee of the CPPCC National Committee, the Supreme People's Court, the Supreme People's Procuratorate, the Organization Department of the CPC Central Committee, the Publicity Department of the CPC Central Committee, the United Front Work Department of the CPC Central Committee, the International Department of the CPC Central Committee, the Policy Research Office of the CPC Central Committee, the National Development and Reform Commission, the Ministry of Education, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State Ethnic Affairs Commission, the Ministry of Public Security, the Ministry of Supervision, the Ministry of Civil Affairs, the Ministry of Justice, the Ministry of Finance, the Ministry of Human Resources and Social Security, the Ministry of Land and Resources, the Ministry of Environmental Protection, the Ministry of Housing and Urban-Rural Development, the Ministry of Transport, the Ministry of Railways, the Ministry of Water Resources, the Ministry of Agriculture, the Ministry of Culture, the Ministry of Health, the National Population and Family Planning Commission, the National Audit Office, the General Administration of Quality Supervision, Inspection and Quarantine, the Sate Administration of Radio, Film and Television, the General Administration of Press and Publication, the General Administration of Sport, the State Administration of Work Safety, the National Bureau of Statistics, the State Forestry Administration, the State Intellectual Property Office, the State Administration for Religious Affairs, the Legislative Affairs Office of the State Council, the State Bureau for Letters and Calls, the State Food and Drug Administration, the National Working Committee on Children and Women under the State Council, the State Council Poverty Alleviation Leading Group Office, the National Committee on Ageing, the Food Safety Commission Office of the State Council, the All-China Federation of Trade Unions, the Central Committee of the Communist Youth League, the All-China Women's Federation, the China Disabled Persons' Federation, and the China Society for Human Rights Studies. 

Since last September, 56 members of the "joint meeting mechanism" have contributed and, in addition, the State Council Information Office organized the formation of a panel of experts to participate in the drafting and formulation of the plan. Experts were invited from a range of universities and research institutions including Nankai University, Sichuan University, the Chinese Academy of Social Sciences, the Shanghai Academy of Social Sciences, and the Party School of the CPC Central Committee. This year, based on the first draft worked out at the end of last year, we have held numerous joint meetings, seminars and discussions, organized officers in charge, experts and scholars to conduct in-depth investigation and research, and have widely solicited opinions and suggestions from departments, social and non-governmental organizations, universities, research institutions and other social sectors through such means as face-to-face communication and letters. The National Human Rights Action Plan (2012-2015) was finalized after rigorous examination, discussion, revision and improvements. The State Council has approved this Action Plan and authorized the State Council Information Office to promulgate it. 

Xinhua: 

What are the guidelines and basic principles for formulating and implementing the Action Plan?

Wang Chen: 

The Action Plan was formulated in accordance with the following guidelines: Holding high the flag of socialism with Chinese characteristics, taking Deng Xiaoping Theory and the important thought of "Three Represents" as guidance and thoroughly applying the Scientific Outlook on Development. In combination with the implementation of The Outline of the 12th Five-Year Plan for National Economic and Social Development of the People's Republic of China, the Chinese government combines its human rights endeavors with economic, political, cultural, social and ecological construction. To satisfy the aspirations of its people of all ethnic groups for living a better life, it continuously prioritizes people's rights to subsistence and development, vigorously safeguards and improves people's livelihood, spares no efforts to solve the problems of the utmost and immediate concern to the people, practically safeguards the citizens' economic, political, social and cultural rights and promotes social equity and harmony, so as to ensure that every member of society live a happier and more dignified life. 

The Action Plan was formulated in line with the following three basic principles: First, the principle of pushing forward the work according to law. In line with the constitutional principle that "the state respects and preserves human rights" and the spirit of the Universal Declaration of Human Rights and other relevant international conventions on human rights, the Action Plan sets out the goal of improving the laws and regulations and their implementation mechanisms for respecting and safeguarding human rights in legislation, administration and law enforcement, so as to promote the cause of human rights in China according to law. Second, the principle of comprehensive advances. Taking all types of human rights as interdependent and inseparable, the Chinese government determines to promote the coordinated development of economic, social and cultural rights as well as civil and political rights, and the balanced development of individual and collective human rights. Third, the principle of pursuing practicality. The Chinese government respects the principle of universality of human rights, but also upholds proceeding from China's national conditions and new realities to advance the development of its human rights cause on a practical basis. 

Xinhua: 

The Action Plan covers a wide range of topics on human rights. Could you briefly tell us about its main points and objectives? 

Wang Chen: 

The major points of the Action Plan are as follows: Providing protection for citizens' economic, social and cultural rights; providing protection for the citizens' civil and political rights; providing protection for the rights of ethnic minorities, women, children, senior citizens and the disabled; conducting education on human rights; fulfilling the obligations to international human rights conventions; and participating in international exchanges and cooperation on human rights. 

The objectives in the implementation of the Action Plan are as follows: 

Providing comprehensive protection to citizens' economic, social and cultural rights. The Chinese government will take proactive measures to protect more effectively the rights of all members of society to employment, basic living standard, social security, health care, education, culture and environment, striving to ensure that all the people enjoy their rights to education, employment, medical and old-age care, and housing, and ensuring that all people share the benefits of the nation's development. 

Providing effective protection to the citizens' civil and political rights according to law. Efforts will be made to improve relevant laws and regulations to protect the citizens' basic rights; work will be done to strengthen judicial protection of human rights to promote judicial justice; and endeavors will be made to develop socialist democratic politics to expand citizens' orderly participation in political affairs, and to ensure people's rights to be informed, to participate, to be heard and to oversee. 

Providing full protection to the lawful rights of ethnic minorities, women, children, senior citizens and the disabled. Further efforts will be made to ensure ethnic minorities enjoy equal economic, political, social and cultural rights; efforts will be made to promote gender equality and eliminate gender discrimination; practical work will be done to safeguard children's rights to subsistence and development, to be protected and to participate; the social security system for elderly people will be improved to speed up the building of an old-age service system; and efforts will be made to develop the cause of the disabled to promote their equal participation in social life. 

Conducting extensive education in human rights. Education in human rights will be consistently carried out among civil servants; human rights education in various forms will be held in all types of schools and at all levels; and human rights knowledge will be publicized throughout the society to enhance the citizens' awareness in this respect. 

Actively participating in international exchanges and cooperation on human rights. China will conscientiously fulfill its obligations to international human rights conventions, take an active part in the work of the United Nations human rights mechanisms, and continuously conduct human rights dialogue, cooperation and exchanges with other countries on the basis of equality and mutual respect. 

Xinhua: 

The formulation, implementation and assessment of the first Action Plan would have provided experiences for the formulation of the second Action Plan. What characteristics does the second Action Plan possess? 
Wang Chen: 

Both Action Plans adhere to the Scientific Outlook on Development which puts people first, and takes realization, preservation and advancement of people's fundamental interests as the starting point and goal of the formulation of the Action Plan. The new Action Plan has the following characteristics: 

First, China's stance and view on human rights are further clarified. The Introduction of the Action Plan illustrates China's view of human rights by specifying three basic principles for formulating and implementing the Action Plan. These are: the principle of pushing forward the work according to law, the principle of comprehensive advances and the principle of pursuing practicality. To advance the development of human rights, China must adhere to the constitutional principle that "the state respects and preserves human rights." We must also adhere to the spirit of the Universal Declaration of Human Rights and other relevant international conventions on human rights. We must promote the coordinated development of economic, social and cultural rights as well as civil and political rights, and promote the balanced development of individual and collective human rights. We must also respect the principle of the universality of human rights, while ensuring cohesion with China's national conditions and new realities. These principles represent China's dialectic understanding of the various internal relations of human rights from the perspective of traditional Chinese culture, which emphasizes harmony and balance. They combine to serve as the central principles for advancing the development of the cause of human rights in China. 

Second, the comprehensive development of human rights is closely integrated with China's 12th Five-Year Plan. In combination with the implementation of the 12th Five-Year Plan, the Action Plan integrates China's human rights endeavors with economic, political, cultural, social and ecological construction, as well as the work plans of various departments in all sectors for the coming four years. In essence, it serves as China's plan for human rights development during the 12th Five-Year period. 

Third, the Action Plan is more feasible and workable. Summing up the experiences from the formulation, implementation and evaluation of the previous plan, the new Action Plan ensures that all objectives are described in detail and that all tasks can be evaluated by clearly-defined standards, so that objectives and tasks can be implemented, examined and evaluated. 

Fourth, the Action Plan attaches greater importance to the role of NGOs and mass media in promoting the development of human rights. According to the Action Plan, China will "improve the social management mechanism and promote the constructive role of NGOs in human rights protection" and "encourage the mass media to play a positive role in the publicizing, implementation and supervision of the Action Plan." 

Fifth, the Action Plan requests that efforts be made to publicize the concept of human rights and spread relevant knowledge, so as to promote public awareness of human rights. The Action Plan prioritizes the education and training of civil servants, and requires the training programs to cover topics related to human rights. Human rights education in various forms will be held in all types of schools and at all levels. For the first time, the Action Plan states that China would "encourage and promote the publicity of human rights knowledge in enterprises and public institutions, and develop a corporate culture that honors and protects human rights." It also states that "China will give full play to the role of national human rights education and training bases," and that "by 2015, at least five new bases will be opened," and "China will make the Action Plan an important part of human rights education and training." 

Xinhua: 

The key to the success of the Action Plan is effective implementation. We have noticed that compared with the previous plan, this plan has a new chapter titled "Implementation and Supervision." What are you planning to do to ensure effective implementation?

Wang Chen: 

Action and implementation are essential to the Action Plan. We have worked hard to make sure the implementation is effective and we wrote a new chapter especially on implementation and supervision to ensure the success of the plan. 

According to the Action Plan: First, relevant departments at the central level, and local governments at all levels, will attach the importance to the Action Plan. While taking into consideration the specific responsibilities of each department and regional characteristics, they will take effective measures to achieve the aims and complete the tasks of the Action Plan. The joint meeting mechanism for the Action Plan will conduct research and examinations at different phases, have a final evaluation and publish the evaluation report. 

Second, the Action Plan will be taken as an important part of human rights education and training, and the mass media will be encouraged to play a positive role in the publicizing, implementation and supervision of the Action Plan. 

Third, in the process of implementing the Action Plan, China will respect and give full play to the public's initiative, enthusiasm and creativity. It will improve the social management mechanism and promote the constructive role of NGOs in human rights protection. Active efforts will be made to probe and improve the social mechanism for protecting human rights in line with the specific conditions of the country as a whole and its different regions and promote the effective implementation of the Action Plan.