The Office of CFDA has started to seek public opinions on Implementation Measures for Drug Trial Data Protection (Interim) on April 26, which is introduced to improve and implement the pharmaceutical product trial data protection system, promote pharmaceutical product innovation, improve accessibility of Chinese innovative drugs, and meet clinical drug use demand.

Data protection system—the intellectual property protection system in parallel with the patent system

As an intellectual property protection system in parallel with the pharmaceutical product patent system, the data protection system will not extend the term of pharmaceutical product patent protection but can provide the most basic market protection for pharmaceutical products without patent protection or with insufficient patent production, especially for the newly developed innovative drugs, with the ultimate aim to stimulate the innovation activities of pharmaceutical enterprises.

The Hatch-Waxman Act offers 5-year data protection term for new chemical entities early in 1984, making the U.S. the world’s first country with pharmaceutical product data protection system.

The data protection system has been relatively perfect in the U.S. Firstly, FDA has clearly defined the scope of data protection that covers extensively, with data protection applicable to new chemical drugs, therapeutic biological products, and pharmaceutical products with new indications; secondly, in terms of way of protection, FDA adopts the mode of "not accepting, not approving", i.e., during the data protection term, relevant generic drug applications will not be accepted or approved after the acceptance, through which, FDA offers the marketing exclusivity to pharmaceutical products eligible for data protection. Like the U.S., the data protection system of the EU also adopts such way of protection.

Upgrading and implementation to help Chinese innovative drugs

As a part of joining WTO, China officially introduced the data protection system when promulgating the Regulations for the Implementation of the Drug Administration Law in 2002, based on which, the Measures for the Administration of Drug Registration revised in 2007 specifically defines the term and conditions of data protection. Data protection later gradually developed and evolved, and underwent specific data protection periods like pharmaceutical product administrative protection and new drug protection.

However, settings of previous regulations on data protection system have many problems during the actual operation, regulations basically rest on theory, and do not lead to the due effect in the specific implementation process.

Those problems mainly include that the scope of application of data protection is not clearly defined and too narrow, and the way of protection lacks operable mechanism, etc. For example, the object to offer 6-year trial data protection is described as pharmaceutical products that "contain new chemical ingredients", which is vague and does not include the biological drugs that are increasingly important at present.

CFDA issued Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Protecting Rights and Interests of Innovators (Draft for Comment) in 2017, with the content including improvement of data protection system, offering different protection terms to innovative drugs, rare disease drugs, and pediatric drugs, etc., showing that problems in old regulations are being gradually improved.

The Implementation Measures for Drug Trial Data Protection (Interim) ("Measures") for which CFDA has started to seek public opinions since April 26 is the upgrading and implementation of the Policy on Encouraging Pharmaceutical Product and Medical Device Innovation: Protecting Rights and Interests of Innovators (Draft for Comment) in 2017. The implementation of the above Measures will help Chinese innovative drugs develop and grow in the long run.

In terms of object of protection, the Measures defines that the objects of protection of pharmaceutical product trial data are innovative drugs, innovative therapeutic biological products, pharmaceutical products for rare diseases, pediatric drugs, and pharmaceutical products succeeded in patent challenge, etc., with the protection coverage further expanded.

In terms of way of protection, the Measures defines that "during the protection term, without consent of the data protection right holder, the national drug administration shall not approve other applicants’ marketing applications for pharmaceutical products of the same variety, except that the applicants depend on trial data acquired by themselves or obtain the marketing authorization". Such way of "not approving" is in line with the current way of protection of the U.S. and EU.

Furthermore, in Article 10 (Technical Review) and Article 11 (Authorization Publicity), the Measures has corresponding provisions for the review procedure and publicity requirements, such as requiring simultaneous publicity of data protection information and pharmaceutical product approval information. Those measures are conductive to the implementation of the data protection system.

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