24 January 2018
Assalamualaikum and good morning everyone.
Welcome to this morning’s roundtable “Balancing Access to Affordable Medicines and Health Innovation” and to the Kuala Lumpur Regional Centre for Arbitration. Some trivia for those who might not know. This used to be the old Shariah Courts. So for anyone having flashbacks of their time here, please accept my apologies in advance.
Allow me to start with a few words about the Galen Centre for Health & Social Policy before I turn to the topic of the day. Established last year, we are an independent public policy research and advocacy organisation based in Kuala Lumpur committed to a free market approach in the development of patient-centric and community-focused health and social sectors. Utilising our expertise in health communications, we advocate public debate and education on ideas and proposals which support individual freedom, choice and innovation.
It is this last which concerns us today and in addressing the challenges faced in ensuring fair and affordable access to effective treatment and medicines.
The patent system is designed to promote innovation and, at the same time, offer a mechanism ensuring that the fruits of that innovation are accessible to society. In the context of public health, the challenge for policy makers is to find an optimal balance between the rights of patent owners, who provide technological innovations to improve health conditions, and the needs of the general public, especially patients and their families. Finding this balance has often created controversy and debate.
It has been argued that the commercial incentives provided by the patent system are not sufficient to ensure the development of new products in certain areas, for example, in respect of neglected and rare diseases, and that patent rights, which are enforced on the basis of commercial and market-based considerations, prevent access to, or increase prices of, essential medicines.
The development of new drugs requires heavy investment and long-term research, coupled with expensive clinical trials and lengthy regulatory approval procedures. Some of you in this room might have or even are now currently involved in such work. The exclusive right conferred by a patent is one of the incentives for developers of new drugs to make the necessary investments into that research.
But it is important to emphasise that intellectual property rights protections should not result in unreasonable charges and exorbitant increases in healthcare costs.
There is a need to clarify issues such as ownership and licensing policies for innovation derived from public research, and expanding on ideas such as delinking the cost of R&D from the final price paid for a medicine. Though they have the potential to be game changers, it is telling that in the case of the latter, despite much campaigning, no country has yet taken the pledge.
Malaysia is growing increasingly rich in intellectual property and research expertise. There are dozens of local companies creating innovative health products, including biopharmaceuticals. If IP protection is perceived to be weak or enforcement is poor, companies will be unlikely to invest or enter into local partnerships. Our own research or innovation projects could stagnate or move abroad. Such concerns and fears could jeopardise efforts such as involvement in future clinical trials and launching of innovative new products into the country.
It is a tough job balancing these concerns and ensuring patient access to much needed drugs, especially if you are the Government.
Ladies and gentlemen.
On 21st September 2017 saw an announcement by the Minister of Health confirming the news that the Government has decided to utilise Section 84 under the Patent Act 1983 (Act 291) to exploit the drug patent and provide for the production of a generic version of Sofosbuvir, to treat Hepatitis C.
This is a groundbreaking move that has been celebrated as being the first country to utilise a government use license to provide the Hepatitis C treatment for around USD 300 per patient.
Today’s event is a platform for stakeholders to discuss and better understand the background behind the decision, particularly in light of concerns surrounding intellectual property rights and protections.
Most importantly, we need to discuss how we can move forward, address concerns related to intellectual property protections, and support the government’s agenda of ongoing national healthcare reform.
We are fortunate to have with us, Dr. Salmah Bahri, Senior Director of the Pharmaceutical Services Division at the Ministry of Health, who is standing in for the Director General of Health, Datuk Dr. Noor Hisham Abdullah today.
She received a standing ovation at the Global Summit of Intellectual Property and Access to Medicines in Morocco, while receiving the Leadership Award in Intellectual Property and Access to Medicines on behalf of the Malaysian government. This was awarded in recognition of the Hepatitis C decision.
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