By Leonard Ariff Abdul Shatar
This article is a cross-Pacific-Ocean response from Leonard Ariff Abdul Shatar, the President, Malaysian Organization of Pharmaceutical Industries (MOPI), to the article “Can the TPPA Cripple Malaysia’s Healthcare System” by Mr. Unny Sankar, who is currently a Mid-Career MPA student and Mason Fellow at Harvard Kennedy School.
I am writing in response to the article published in The Citizen, the student newspaper of the Harvard Kennedy School entitled “Can the Trans-Pacific Partnership Agreement Cripple Malaysia’s Healthcare System?” written by Mr Unny Sankar.
Whilst I am fine with individuals presenting their views on subjects that they may not be particularly familiar with, this particular article made the rounds globally due to the fact that Mr Sankar was once a member of the Malaysian Trans-Pacific Partnership Agreement (TPPA) negotiating team for Malaysia.
I sincerely hope that Mr. Sankar’s personal opinion does not reflect the stance of the Malaysian negotiating team due to the fact that Mr. Sankar has taken an extremely simplistic view on the issues that have caused such an emotive response from not just NGOs but also members of the public. I represent the Malaysian Organisation of Pharmaceutical Industries (MOPI) in Malaysia, which represents the majority of generic drug manufacturers in Malaysia and would like to present a factual rather than emotive response to Mr. Sankar’s article.
Mr. Sankar’s article claims that the TPPA will not increase prices of generics and that the TPPA will increase the number of branded drugs available in Malaysia. This is a particularly disingenuous argument given that Malaysia has one of the most open drug registration systems in Asia. As long as a drug meets the particularly stringent drug registration process in Malaysia, there are no impediments to registration. This drug registration system is equally applied to both local and overseas manufacturers. The unavailability of a particular drug in Malaysia tends generally to be a commercial consideration by the manufacturer, given the small size of the Malaysian market, rather than caused by any impediment that the TPPA seeks to resolve.
On the issue on pricing, the Malaysian public is already paying a hefty price for delayed entry of generics given that whilst the so called ‘patent cliff’ for small molecule drugs has passed in the US and in Europe, for a lot of these molecules, they are still protected by patents in Malaysia. In some Oncology small molecule drugs, we are seeing patents in Malaysia surviving up to 9 years longer than in Western economies. Whatever the reason for this, it is the private and public healthcare system in Malaysia that bears the brunt of this mismatch of patent expiries. I have personally sat through presentations at a TPP Stakeholder Consultations where US Pharmaceutical pressure groups indicate that the average patent protection they are receiving is less than 13 years and as such they require the TPPA to fix this. I am not sure which economies they are referring to but I assure Mr Sankar that it certainly is not Malaysia where protection is for 20 years from lodging or 15 years from grant, whichever is longer.
Mr Sankar’s assertion that the TPPA will have no impact on the price and availability of generics is particularly troubling. Even without the TPPA, the generic drug industry in Malaysia is already reeling from Malaysia’s delayed expiry of patents relative to our neighbouring countries. For a country attempting to develop a robust export platform for our generic drugs, we are already at a huge disadvantage. BOLAR provisions that were intended to facilitate early introduction of generics upon expiry of patents have also been severely curtailed due to new regulatory requirements for registration. The TPPA does not do anything to encourage the early introduction of generics
Mr Sankar also seems to be taken in by the argument that the TPPA only applies to “new medicines”. The problem revolves around the definition of “new”. Even before the TPPA, we are already seeing formulation tweaking, minor amendments to dosage delivery, slight changes in manufacturing processes and isolation of known isomers all regarded as “new” and therefore justifying extensions of patents. The TPPA will serve to enshrine this practice of ever greening patents into a commitment by Malaysia’s Patent Office further delaying introduction of generic versions of essentially the same drug. The article by Mr. Sankar seems to acknowledge the benefits of competition afforded by generics but at the same time supports a diametrically opposed view of supporting the practice of ever greening patents as contained in leaked drafts of Intellectual Property Chapter of the TPPA.
The Ministry of Domestic Trade, Cooperative and Consumerism in Malaysia have engaged stakeholders in Malaysia on the TPPA. I am confident that through these stakeholder dialogues, the more knowledgeable members of the Malaysian TPPA negotiation team fully understand the impact to Malaysia’s Healthcare system of attempts to institutionalise the practice of evergreening patents, extending Data Exclusivity attaching to Biotherapies to 12 years from the current Data Exclusivity period of 5 years and also attempts to introduce patent linkages. There are many other reasons for the vociferous objections to the terms of the Intellectual Property Chapter in the TPPA beyond just availability but ultimately it will be the Healthcare system in Malaysia that will bear the folly of agreeing to the proposed Intellectual Property Chapter in the TPPA.
MOPI’s position on the TPPA has been consistent. As a large trading Nation with a relatively small population, we are totally in support of the TPPA to encourage global trade. We are supportive of a fair Intellectual Property regime to reward true innovation. What we are against is abusing Intellectual Property laws to support any extension of patents in whatever form that delays access of the Malaysian Healthcare System to affordable generics and Biosimilars. The Malaysian Healthcare System is already crippled due to the current patent regime in Malaysia, so we do not need the TPPA in its current form to chop the System at its knees.