PETALING JAYA: The Health Ministry must strike a balance between incentivising innovation and ensuring accessibility of key generic drugs in implementing patent linkage for pharmaceutical products, say health professionals.
This comes after the ministry revealed that it is drafting guidelines to ensure hospitals have constant access to generic medicines even during legal challenges from innovator drug producers over patent issues.
“The guidelines would help to strengthen the regulatory ecosystem and align with international commitments,” said Pharmaniaga Berhad managing director Datuk Zulkifli Jafar said.
“Through enhancing transparency and providing greater clarity in the medicine approval process, it will also support greater confidence among industry stakeholders.”
However, Zulkifli said the framework must be well-balanced to support innovation while also ensuring continued widespread access to affordable generic medication.
“It is crucial that such a framework does not inadvertently delay the availability of essential and affordable generic medicines, particularly for the public healthcare system where generics play a vital role in cost management and broadening patient access.
“We will continue to engage with the ministry and other stakeholders as the framework is refined to ensure it supports both industry growth and patient access,” he added.
Malaysian Organisation of Pharmaceutical Industries president Ch’ng Kien Peng said the guidelines are unlikely to significantly affect the government’s “Generic First” policy.
“There will be minimal impact as the guidelines mostly just introduce a formal notification mechanism and defined timelines for resolving patent-related matters without affecting patent rights.
“For patent holders, the proposal would offer greater clarity and an opportunity to seek legal recourse when a generic company intends to market a product while a patent remains in force.
“Generic manufacturers may, in certain cases, only face a temporary delay due to the procedural steps such as notification, but can still be resolved by early filing and regulatory evaluation,” he said.
Public health medicine specialist Datuk Dr Zainal Ariffin Omar, however, cautioned that the patent linkage guidelines could cause the generic drug approval process to be delayed.
“Generic drug companies would have to declare that their products do not infringe on existing patents and patent owners will likely be given a formal window of maybe 30 days to sue for infringement.
“This would automatically stall the National Pharmaceutical Regulatory Agency’s approval process until the court case is resolved, thus creating a significant new barrier to entry and will likely increase costs for generic drugmakers,” he said.
He also said the proposal could strengthen and extend the legal monopoly of brand-name drugs by preventing non-brand name drugs from reaching markets.
“The proposal would move the battleground from the usual courts, after a product is launched to the market, to the regulatory approval stage itself, before the product is even launched.
“This provides a powerful, early mechanism for patent holders to block generic competitors entirely before they enter the market,” he said.
Zainal said the proposed guidelines would also significantly strengthen patent protection by preventing the approval of potentially infringing generics.
He said this would reduce costly post-market litigation and secure longer market exclusivity of patented drugs.
“Generic drug manufacturers can also benefit as it will provide them a formal linkage system with a patent registry that provides legal clarity and predictability on patented drugs.
“This allows them to ‘design around’ valid patents properly and better challenge weak patents earlier,” he added.
