Indian imitation drugs have no precedent in China

Business October 10th news why the "Indian version of cancer drugs" price is so low? Recently, the reporter interviewed a number of people in the medical industry and learned the reasons:

Targeted anti-cancer drugs are imported, the patent cost is high. The Indian government, from the perspective of protecting the public health of its citizens, enacted laws to relax the conditions for domestic pharmaceutical companies to imitate anti-cancer drugs, resulting in a great reduction in costs. Intellectual property experts said that the biggest beneficiaries of the compulsory drug licensing policy are poor patients, drug companies may not have high profits in the production of generic drugs, and domestic drug companies have insufficient motivation to copy drugs.

Industry analysis

The high price of imported anticancer drugs is related to rebates

Li Hua (a pseudonym), the person in charge of a pharmaceutical sales company, said that the high price of domestic regular imported cancer drugs is related to the high rebate in the field of Chinese medicine (22.24, 0.98, 4.61%). "Any company that does not give kickbacks to hospitals will close down within three months." He said that life-saving anti-cancer drugs are regarded as the most valuable cash cow in the medical industry, and the problem of high kickbacks and high drug prices is more prominent.

He calculated an account, a factory price of 3,500 yuan per box of imported cancer drugs in Europe and the United States, transferred to a first-level agent to increase the price of 8% to 10%, to the secondary distribution company to add 6% to 8%, and finally into the hospital, generally to add 15% rebate points.

Therefore, each box of this drug to the patient to pay the stage, has been as high as 5,000 yuan. And anti-cancer drugs are generally purchased according to the course of treatment, the total price is more expensive.

Enterprises with patent protection can not be copied at will

Li Hua said that the reason why targeted anti-cancer drugs are expensive is its particularity. These drugs are well-known pharmaceutical companies in Europe and the United States research and development, due to patent protection, domestic enterprises can not be copied at will, domestic medical institutions can only import through formal channels.

Drug price costs include manufacturing costs and research and development costs. "If you calculate purely on manufacturing costs, the profit margin of targeted anticancer drugs is more than 90%, but this is a layman's algorithm." Look at the profit of the drug, also depends on the research and development link, and the research and development cost has a greater impact. For example, for a cancer drug, the cost of clinical trials is more than a billion dollars, which must be borne by patients." 'he said.

Mr. Li said that many countries have a patent protection period for drugs, during which imitation is not allowed. As far as he knows, there are few pharmaceutical companies whose sales performance is so poor that they do not make money during the patent protection period.

The low price of the "Indian version of cancer drugs" is related to India's patent protection laws.

India only began to recognise drug patents in 2005. But India's patent law, which came into effect in January 2005, provides patent protection only for new drugs invented after 1995 or those that have been modified to substantially improve their effectiveness. At the same time, the Indian government can impose "compulsory licensing" as needed.

Yu Mingde, president of the China Pharmaceutical Enterprise Management Association, said in an interview with the media that Indian law stipulates that local enterprises can apply for compulsory licenses to the Indian Intellectual Property Office to produce and sell generic products "in the event that they cannot obtain, afford or properly provide them." "Compulsory license" has become a sword of imitation by many Indian pharmaceutical companies. Many multinational companies refused to accept the lawsuit in India, but all failed.

On April 1, India's Supreme Court rejected a claim by Swiss pharmaceutical giant Novartis for patent protection for Gleevec, arguing that local generics could continue to be sold in India. Gleevec was rejected on the grounds that it was not an innovative drug.

The Indian generic version is not much different from Novartis' Gleevec, but costs 20 to 40 percent less. "This is a huge relief for the millions of patients and doctors in the developing world who depend on medicines from India," said Medecins Sans Frontieres president Karunlekaya.

Expert statement

China has no regulations to encourage generic drugs

In the five years from January 1, 2012 to December 31, 2016, as many as 631 patented drugs will expire worldwide. The arrival of the peak expiry of patent drugs means that for many developing countries, there will be more market and space for generic drugs, and multinational pharmaceutical companies have applied for patent extensions.

Pharmaceutical industry analyst Bian Chenguang told media reporters that multinational pharmaceutical companies apply for patent extensions out of interest. As a result, there is an irreconcilable contradiction between multinational pharmaceutical companies and developing countries - the confrontation between interests and people's livelihood.

He believes that the fundamental basis of enterprises is interests, while the basis of national government is people's livelihood. The high price of foreign drugs has put off many patients, but the country cannot afford to stand by.

At present, China does not have policies and regulations to encourage generic drugs, Bian said.

Several intellectual property experts said that China is not behind India in terms of legal provisions for compulsory licensing. The State Intellectual Property Office promulgated the Measures for Compulsory Licensing for Patent Exploitation in 2003 and the Measures for Compulsory Licensing for Patent Exploitation involving Public Health in 2005.

But Li Mingde, a researcher at the Intellectual Property Centre of the Chinese Academy of Social Sciences, said "not a single case has happened".

It is understood that if domestic pharmaceutical companies want to legally force imitation of a patented drug, they need to apply to the Food and Drug Administration and the Health and Family Planning Commission, and then the health and Family Planning Commission applies to the State Intellectual Property Office for public health reasons.

"Once localization takes place, costs will drop dramatically," said Li Hua, head of a pharmaceutical company.

However, the enthusiasm of domestic pharmaceutical companies to apply for compulsory licenses is not high. He said this was mainly due to the complicated and lengthy drug approval procedures. "For some drugs, the patent protection expires in 2017, and if I apply for a compulsory license now, it will take about three years to get it approved, and it won't be long before the protection expires."

Li Shunde, another researcher at the Intellectual Property Center of the Chinese Academy of Social Sciences, analyzed that another reason for the lack of motivation for domestic pharmaceutical companies to apply for compulsory licenses is that "the biggest beneficiaries of compulsory drug licensing policies are poor patients." It may be less profitable for pharmaceutical companies to produce generic drugs than to export apis to multinational companies."