KUALA LUMPUR, Dec 4 — Malaysians will not lose access to cheaper generic drugs if the country enters into the Trans-Pacific Partnership (TPP), according to a cost-benefit analysis conducted by audit giant PricewaterhouseCoopers (PwC).
Released today, PwC’s report of its analysis on the impact of selected key sectors on Malaysia’s economy showed that generic drugs will not be restricted in the country due to the similarity of the patent terms filed.
The report added that the development and production of cheaper drugs will also not be affected as they took longer than the five-year data exclusivity term for biologics.
Biologics are drugs made from biological rather than synthetic sources that have revolutionised the treatment of cancer, HIV/ AIDS, Alzheimer’s disease, cardiovascular diseases and autoimmune disorders, among others.
“In conclusion, the key findings indicate that the TPPA obligations do not pose detrimental risks to the future growth of biopharmaceutical manufacturing industry,” the report stated.
“While the obligations are largely similar to the current practice in Malaysia with regards to small molecule drugs, the TPPA impose additional obligations to biologics i.e. on data exclusivity. However, data exclusivity for biologics does not seem to pose challenges as it will take longer than five years for biosimilars to be developed.”
It concluded that patent term adjustments under the TPP only provided for compensations due to delays in patent approvals and marketing applications, adding that issues won’t be a concern because the National Pharmaceutical Control Bureau has fully completed processing the applications last year.
The study also found that the five-year data exclusivity term on biologics would not affect the production of biosimilars ― the generic drug equivalent for biologics ― because manufacturers have in the past taken between six and 13 years to roll them out.
Malaysia currently does not have any regulation on data exclusivity for biologics, which deals with other drug manufacturers’ right to access vital information on test results on the patented creation.
Malaysia’s public healthcare is currently heavily subsidised, and has resulted in widespread dispensation of generic drugs and biosimilars.
Concern first grew over potential price hikes in medicine and a longer wait for generic drugs after a leak in confidential documents over the TPP pointed towards strict enforcement of Intellectual Properties in member countries.
Negotiations over the TPP, which would create the largest trade bloc on both sides of the Pacific Ocean involving 12 countries, have been shrouded in secrecy for years and its contents only unsealed last month.
Malaysia is among the countries involved with the US, Canada, Japan, Vietnam, Singapore, Brunei, Chile, New Zealand, Australia, Mexico and Peru also on the table.
Parliament is expected to debate the TPP early next year.