New Drugs Guidelines Promise Big Progress in Use of Generics

China will promote the production of generic drugs - while encouraging the development of new medicines - according to remarks made at a China Food and Drug Administration news conference.

The State Council released guidelines on reforming new drug approval procedures on Sunday, addressing ways to boost innovation of drugs and medical equipment.

The government will periodically release a list of drug patents that are no longer valid, to guide drug companies in the production of generics.

New technological regulations will be also released to promote research and evaluation of generics, to speed up evaluation of the quality and efficacy of the drugs.

The protection of drug patents is in line with China's push to build itself up as an innovative country, while upgrading its pharmaceutical industry, said CFDA Vice-Minister Wu Zhen.

"We encourage innovation and we encourage generic drugs too," Wu said.

"When original patent terms lapse, sales of generics will cut down the price of those drugs, and lead to easier access for their clinical usage."

Currently, there are more than 4,000 pharmaceutical companies in China producing generic drugs.

Competition between them used to be unregulated and the quality of their products were sometimes uneven and unsatisfactory.

Analysts of the sector said that as a result China needed to put more effort into promoting innovation in the industry.

The guidelines propose the concept of a pharmaceutical patent linkage system, involving a combination of drug registrations and patents.

The CFDA is responsible for registration of medicines, while the State Intellectual Property Office handles patent applications.

The combination of the two sectors will enable the resolution of patent infringement cases before the drugs are put onto the market and reduce the cases of patent infringement caused by generic drugs, Wu added.

The guidelines suggest pilot programs for compensation for patented drug developers during the administrative approval procedure for new drugs.

The longer the approval process takes, the longer the delay will be for the launch of new drugs onto the market, and the closer to the expiry of the patent - reducing the revenues due to the drug companies and patent owners.

Wu said the government should therefore consider reasonable compensation.

The guidelines also call for a certain period of protection from wider commercial use for the drug developers' experimental data and research.

Those new measures were first defined in developed markets - including the US, Japan and Europe, in the 1980s and 1990s - to facilitate innovation in drug management.

Implementation of them in those markets were successful and stimulated the production of generic drugs, Wu said.

The guidelines will construct a scientific and systematic mechanism to protect the ownership of intellectual patents, he said.

It will also pave the way for more innovation in the booming pharmaceutical industry, especially in Chinese medicine, boosting development in all aspects of the sector, Wu added.

Source: China Daily