In 1998, Malaysia's Drug Control Authority (DCA) registered 22,085 drugs and traditional medicines out of about 40,000 applications received. Of the total number of registered products, 8,187 were prescription drugs, 5,415 over-the-counter (OTC) drugs, and 7,819 traditional medicines.
Over 65 per cent of Malaysia's pharmaceuticals are imported, in part because most doctors are reluctant to switch to local brands as they prefer the higher quality of imported drugs. Thus, compared to imported drugs, most local drugs are common/general pharmaceuticals such as painkillers and antibiotics since it is not economically feasible to target a specialized segment.
Recently, the Pharmacy Board of the MoH has been encouraging additional improvements in the dose drug distribution system, clinical pharmacy component, total nutrition services, and patient medication counseling. It is also trying to increase the purchases of pharmaceutical preparations in the market, reduce the manufacture of pharmaceuticals in hospitals, and implement Good Manufacturing Practices (GMP) in hospital manufacturing laboratories.
Medical devices
Since the early 1990s, Malaysia's medical device market has been growing at 15 - 20 per cent annually. The country's medical device market is currently worth about $300 million, with imports accounting for more than 90 per cent of this total. Because of the significant ringgit depreciation from the crisis and the subsequent increase in import prices, Malaysia's medical device market suffered a setback between 1997 and 1998. There are currently very few trade barriers or regulations for imported medical equipment in Malaysia. Only latex rubber products (i.e. condoms, surgical gloves) require certification by the Ministry of Health, and the government also maintains some safety-related regulations on certain devices - for example, it is government policy not to buy used/refurbished medical equipment, or allow new, experimental products into the country without FDA or other international standard approval.
Intellectual property protection
The Malaysian government plans to implement new measures in the enforcement of intellectual property rights, including the creation of new legislation and conducting reviews of existing legislation. These actions are intended primarily to conform to the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement implemented by the World Trade Organization in 1995. They are also in response to growing concern over the widespread production, distribution and use of illegally produced software and technology.
Patents
The current legislation governing patents is the Patents Act (Amended) 1983. This legislation currently requires that anyone applying for a patent must do so through a patent agent. The patent agent takes care of all the necessary paperwork, however, the "inventor" must fill out an Authorization of Agent Form to empower the patent agent to act on behalf of the applicant.
The application goes through several stages of examination, and it generally takes between 3 - 5 years before the patent is approved depending on the complexity of the invention. Once approved, the protection period for the patent is for 15 years from the date of patent approval. The patent owner has exclusive rights to exploit, assign or transmit as well as conclude license contracts in relation to the patent. This includes making, importing, offering for sale, selling, or utilizing the invention.
Utility Innovations
A "utility innovation" is defined as "any implement, tool, product or process which is of practical utility by reason of its form, configuration, construction or composition." A utility innovation does not have to fulfill the same requirement of inventiveness as a patent. Therefore, any invention that does not meet the inventiveness requirement may have the item registered instead as a utility innovation. The application process for obtaining a Utility Innovation Certificate is the same as that for a patent. The certificate provides the same protection as that of a patent, but is only valid for 5 years from the date of approval.
Trademarks
Trademarks must be registered through the same application process as a patent, utilizing a patent agent. There is a three-stage approval process, which can take from 3 - 5 years. Currently, once registration is approved, trademark protection is granted from the date of filing for a period of 7 years, after which it is renewable for 14 years. The Trade Marks (Amended) Act 1994, which has not yet gone into effect, will extend the initial protection period to from 7 years to 10 years. The registered owner of the trademark has the exclusive right to utilize the mark in relation to the goods for which it is registered.
Industrial Designs
An industrial design only refers to the shape, configuration or pattern that has been applied to a particular article, not the article itself. In order to be registered, the design must be able to be "judged solely by the eye". The design must not have been used or published prior to the submission of the registration application.
Previously, industrial designs were covered under the United Kingdom Designs Protection Act 1949. However, the Industrial Design Act 1996 (Malaysia) will now allow applicants to file directly with the Malaysian government. Protection is extended for three consecutive (renewable) five-year terms, after which, anyone can use the design.