Patent barriers to affordable drug prices
The Government needs to look into removing patent barriers that contribute to high drug prices in the country before turning to social health insurance scheme (SHI) to finance the population’s rising healthcare cost, says Penang-based Third World Network (TWN).
Unnecessary patent monopoly and additional patents that extend monopolies beyond 20 years have pushed up the cost of some crucial medications, according to TWN programmes director Chee Yoke Ling.
“Our patent law and standards for pharmaceutical patents need to be tightened up first,” says Chee in an exclusive interview with The Star on whether SHI was needed to finance increasing healthcare cost.
Chee says the Patents Act 1983 has been under review for several years and the Government should align it with national competition and public health objectives. The scope of patentability under the Act should be revisited to minimise practices that unduly prevent much needed public access to affordable medicines.
Due to the “evergreening” tactic by pharmaceutical companies, for one, there can be many patents surrounding a single drug.
“They apply for new patents based on a different dosage, a combination of two existing medicines that were no longer patent protected or made some changes to a salt used as part of a medicine. These secondary patents as they are called, often do not add curing value to a medicine but they get another 20 years,” she says.
However, in many countries, for a new patent to be granted, the subject matter must truly be new, involve an inventive step and could be used at the industrial level.
Unlike in Malaysia, combination of drugs are not considered new in some countries, allowing them more access to generic versions of drugs, she adds.
Chee cites the example of imatinib used for treating Chronic Myeloid Leukaemia. The basic compound patent expired worldwide between 2014 and 2016.
The drug company did not file for a base compound patent in Malaysia but for the imatinib 400mg, two patents on crystal forms (expire 2022) and another on tablet form (expire 2023), have been obtained, she says, quoting the data base of the Malaysian Intellectual Property Corporation that examines and grants patents.
According to the Malaysian Competition Commission (MyCC) Market Review on Pharmaceutical Sector under Competition Act 2010 and the Health Ministry, the ministry was paying RM74.87 per 100mg tablet and RM276.33 per 400mg tablet from 2016 to 2018, she says, adding that the standard dose for imatinib is 400mg daily.
In India, where patent-granting standards are stricter, generic Imatinib can be available at about RM12 per 400 mg tablet (distributor price provided by Medecins Sans Frontieres’s India Access Campaign), she says.
“As a result of the ever greening process, Malaysia is not able to gain access to much cheaper generic version of some badly needed drugs.”
Quoting MyCC’s market review, TWN legal researcher Karina Yong says that it also recommended that all Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities be included in the Patents Act.
“There should be closer cooperation among the Health Ministry, the Domestic Trade and Consumer Affairs Ministry and International Trade and Industry Ministry in dealing with patent and trade-related issues that have an impact on public health,” says Yong, adding that Malaysia should study examples from countries such as South Africa in regulating medicine prices and Philippines, which mandates that prescriptions to patients must include a choice of at least two generic medicines. — By Loh Foon Fong