Replies to LegCo questions
LCQ17: Drug registration system
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
NNNN