PHARMACEUTICAL companies have been accused of making slight modifications to their drugs to extend a patent life span.
This has resulted in calls for the government to not recognise process methods for patenting, and allowing only molecular patents.
However, the Pharmaceutical Association of Malaysia (PhAMA) argues that modifications do make a difference.
Different salts, for instance, have been patented because in pharmaceutical process, they have different pharmacological properties and would exert different effects on patients, it says.
“And despite it being in public domain or knowledge, one is not able to predict which salt form is able to provide the desired therapeutic effects,” it says, in response to local drug companies producing generics complaining that big pharmaceutical companies had patented products that were not novel.
The Star recently reported that the local players had asked the government to be stricter in issuing patents.
According to PhAMA, both innovative and generic pharmaceutical companies do file for and own patents but patents are granted on the basis of novelty, inventive steps and industrial applicability.
It says that after discovering a compound and registering it as a patent, a drug company has 20 years of protection for the patent where it will then carry out pre-clinical trials, and Phases 1 to 3 clinical trials, all which may take 10 to 12 years. After the trials, the company submits the results for product registration and the authority will evaluate the document.
It says that generally, companies file for patent globally in multiple countries almost at the same time.
PhAMA president Chin Keat Chyuan says that Intellectual Property (IP) rights are defined by the World Trade Organisation as “rights given to people over the creations of their minds.”
“The research and development efforts that are undertaken by innovator pharmaceutical companies are high-risk and costly ventures with no guarantee of positive returns. Once a drug has been successfully created, it is susceptible to being copied by third parties through reverse engineering as pharmaceutical compounds can be easily imitated once they have been discovered.
“Hence, a patent would prevent a third party from exploiting another person’s invention and unjustly benefiting from it without any legal consequences,” he says.
Chin says that a strong IP regime is critical for Malaysia to boost its competitiveness, especially to attract foreign direct investment while at the same time encourage technological advancement and innovation.
The pharmaceutical industry regards patents as the most important legal protection for the limited time the commercial rights of the drugs and medicines that they invented, he says.
PhAMA also refutes allegations that the Patient Access Scheme (PASc) locks-in patients and does not address the high cost of drugs. “The question of patients not being able to gain access to drugs due to high price is not applicable because the government has allocated for the drugs in the formulary,” it says, stressing that the PASc gives poor patients access to the treatment.
The pharmaceutical company applies to the Health Ministry to benefit the patients and this alleviates the government’s financial burden, it adds.
It is a public-private partnership which the industry proposed and patients were either given full or partial sponsorship of the drugs by drug companies, says PhAMA, adding that there are PASc guidelines to adhere to.
Asked about the criteria for choosing patients and the terms of discontinuance, PhAMA says that the patients are selected by doctors at the Health Ministry and the terms are set by the ministry.
According to PhAMA, between 2013 and 2016, more than 10 PhAMA members offered PASc in Malaysia, benefitting some 12,000 patients.
The approach is in line with one of the UN Sustainable Development Goals targets to provide universal health coverage, and the second strategic thrust of the Eleventh Malaysia Plan, which focuses on improving wellbeing for all, says Chin, adding that it welcomes the review of of the PASc by the National Audit Department.
The Health Ministry’s pharmacy practice and development division has recently consulted the department to review hospitals’ medication procurement practices, particularly on hospital staff accepting free gifts and bonuses in these deals.
According to an online portal report on Oct 5, preliminary findings showed that there had been no unethical practices.
Chin believes that generics alone are not the solution to medicine access.
“Nearly all of the World Health Organisation’s ‘essential medicines’ are available at reduced, off-patent prices, but more than a third of the world’s population still has no access to them.
“Also, despite India being home to the largest and most vibrant generic industry in the world, for the 40% of the population that lives on less than US$2 (RM8.40) per day, medicines and other healthcare needs are not affordable at any price,” he says, adding that the lack of infrastructure also poses a barrier to access.