10. Conclusion: The impact of the proposed Guidelines on the generic industry, generic competition & access to affordable pharmaceutical products will be devastating

Section 2 of the proposed Guidelines claims that the mechanism will be “safeguarding access to medicines” while Section 3 of the proposed Guidelines claims that patent linkage is a “regulatory mechanism that aims to balance incentives for innovation and access to affordable medicines.” Both assertions are unfounded. In practice, there is substantial evidence that patent linkage delays generic entry, resulting in prolonged periods of high medicine prices borne by patients and the public health system. Rather than achieving a balance, the proposed approach risks undermining access to affordable medicines. The Guidelines undermine the objectives set out in NIMP 2030. It will weaken Malaysia’s generic industry, which is likely to struggle with the additional barriers to market entry—particularly the increased risk of costly and strategic legal challenges initiated by patent-holding originator companies. Further, the progress achieved under the National Generic Medicines Framework— grounded in the Malaysian National Medicines Policy and designed to promote the use of generic medicines—risks being undone by the proposed Guidelines.

Specifically on patent linkage, the UN Special Rapporteur on the right to health has highlighted that it “would affect the entry of generic medicines” adding that by “delaying the process of granting marketing approval, patent linkage provides patent holders with additional opportunities to prolong their monopoly rights and delays the entry of generic medicines into the market”. The Special Rapporteur also stressed that “[p]atent linkages, by not allowing the registration of generic versions of patented drugs can also adversely impact the early working exception, which ensures the immediate entry of generic competition after the expiry of the patent. Similarly, refusal to register also creates uncertainty in relation to compulsory licences”.

Patent linkage also increases pharmaceutical imports of the originator’s product, as the domestic generic industry will be prevented from supplying, thus affecting Malaysia’s trade balance of payments (i.e. more imports than exports) and employment if the local generic industry is unable to grow. In a global environment of unstable global supply chains a weakened local generic industry will also undermine Malaysia’s national pharmaceutical supply security.

In conclusion, we reiterate our call and request NPRA to withdraw the proposed Guidelines on Implementation of Patent Linkage for Pharmaceutical Products in Malaysia and to undertake meaningful consultations with civil society organizations and patient advocacy organisations on the best way to approach implementation of Article 18.53 of the CPTPP.

Contact:

Mohideen Abdul Kader

President, Consumers Association of Penang

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Datuk Indrani Thuraisingham

Vice President and Legal Advisor, Federation of Malaysian Consumers Associations (FOMCA) This email address is being protected from spambots. You need JavaScript enabled to view it.

Chung Han Yang

Deputy Executive Director Malaysian AIDS Council (MAC)

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Dr Murallitharan M.,

Managing Director, National Cancer Society of Malaysia

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Chee Yoke Ling Executive Director,

Third World Network

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