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Following is a question by the Hon James To and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (July 11):
Question:
The Registration Committee under the Pharmacy and Poisons Board deregistered 19 generic drugs in January this year on the grounds that the Committee could not contact the three companies holding the registration certificates of these pharmaceutical products. It has been reported that these companies have allegedly infringed the patents held by others. In this connection, will the Government inform this Council:
(a) of the measures currently in place to follow up the applications for registration of drugs which might have infringed intellectual property;
(b) why the Government has not followed the practices of the authorities in the United States, Singapore and the Mainland to enact legislation to establish linkage between pharmaceutical patents and drug registration, so as to ensure that approval for registration is granted only to the drugs which do not infringe any patent; and
(c) of the measures currently in place to check the background and financial position of the companies which lodge applications for drug registration (the relevant companies) and their persons-in-charge, to ensure that affected patients and medical practitioners may seek compensation for losses from the relevant companies in the event that the drugs are deregistered or recalled, and to ensure companies whose pharmaceutical patent rights have been infringed have the right to demand the relevant companies to recall the drugs concerned?
Reply:
Madam President,
The deregistration of drugs as mentioned in the question must be referring to the incident that took place in January this year. The Registration Committee (the Committee) under the Pharmacy and Poisons Board (PPB) came to know that the holders of the registration certificates of 19 pharmaceutical products no longer ran their business at the addresses stated on the registration certificates and had made many attempts to contact the three companies and the persons concerned, but to no avail. Acting on legal advice, the Committee deregistered the pharmaceutical products. The deregistration had nothing to do with drug safety or patent infringement. My reply to the three parts of the question is as follows -
(a) At present, the drug registration system and the patent protection system in Hong Kong provide respectively assurance of safety, efficacy and quality of drugs in the local market and protection for technical innovation by granting the inventor a patent for his invention.
Under the Pharmacy and Poisons Ordinance (PPO), all drugs are required to be registered before sale in Hong Kong. The purpose of the legislation is to protect public health and drug safety. The PPB will grant approval for registration of drugs which comply with the scientific criteria of safety, efficacy and quality.
On the other hand, the Patents Ordinance and its subsidiary legislation provide for the registration and protection of patents in Hong Kong. Our patent protection system is administered by the Intellectual Property Department and is in full compliance with the requirements under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the World Trade Organization (WTO). Patent owners have the right to prevent third parties from, among other things, making, putting on the market, using, importing or stocking patented products without their consent. Patent owners may institute civil proceedings in courts against infringers of their rights and seek remedies, including an injunction restraining the defendant from any of the above mentioned patent infringement acts; an order requiring the defendant to surrender or destroy any patent-infringing products; damages in respect of the infringement; an account of the profits derived by the defendant from the infringement; and a declaration that the patent is valid and has been infringed by the defendant.
The rights of patent owners to civil remedies are not affected by the PPB's registration of the relevant drug. In addition, the TRIPs of the WTO does not require the linkage of patent considerations with registration of drugs.
(b) "Patent linkage" generally refers to the linkage of patent with registration of drugs, i.e. a drug is not to be registered if it may infringe a patent.
The drug registration system in Hong Kong is established for the protection of public health and does not deprive patent owners of any protection under the Patents Ordinance. We also note that the "patent linkage" proposal could cause unnecessary delay in the process of drug registration because of patent reasons and hence affect the availability of drugs. As there is already a well-established patent protection system in Hong Kong, the drug registration system should focus on the safety, efficacy and quality aspects. That said, we will keep track of the overseas developments in drug registration and consider reviewing the existing system when appropriate. At present, the drug registration systems of the European Union (27 countries in total) do not take patent into account.
(c) In the course of processing applications for drug registration, the PPB will require applicants to submit the business registration certificates of their companies. The PPO also stipulates that only companies holding a wholesale poisons licence issued by the PPB's Licensing Committee may import or distribute the drug after its registration. If a drug is deregistered or recalled on grounds of public health, importers and distributors would be responsible for the recall. Individuals such as patients or doctors may seek compensation from the wholesalers. Patent owners may institute civil proceedings against any suspected infringement of their patents and seek remedies.
Ends/Wednesday, July 11, 2007
Issued at HKT 15:13
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