KUALA LUMPUR, May 19 — An American pharmaceutical lobbying group has called for greater transparency in how Malaysia lists medicines in its national formulary that are provided in public facilities.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing companies in the United States’ (US) pharmaceutical industry, said it welcomed government advances for drug companies to directly request inclusion on the Ministry of Health’s (MOH) national medicines formulary through 2016 guidelines.
However, the American pharmaceutical industry is disappointed that the process “lacks transparency and appears to be based on ambiguous criteria”, PhRMA said in its recent submission for the United States Trade Representative’s (USTR) annual review on US trade policies, the 2020 Special 301 Report.
PhRMA made reference to MOH listing decisions, both by the body responsible for conducting health technology assessment analysis and making listing recommendations, and by the panel responsible for the ultimate listing decision.
“In addition, if a product is not approved for listing on the Formulary, the applicant should be provided a detailed explanation for that decision so that it can better understand the criteria for listing and to determine if it may negotiate an alternative access scheme with the government.”
Treatments listed on the MOH Medicines Formulary, also known as the “Blue Book”, are provided for and funded by the government in MOH health facilities, though not all patients are guaranteed access to these drugs when certain medicines run out of stock. University and private hospitals have their own individual formularies.
In the United Kingdom, a separate body called the National Institute for Health and Care Excellence (NICE) recommends which medicines the National Health Service (NHS) should fund based on the treatments’ effectiveness and value for money, whereas in Malaysia, MOH itself decides what medicines it should purchase and provide in its own facilities.
CodeBlue previously quoted cancer physicians as questioning why MOH does not negotiate with pharmaceutical companies for lower drug prices, instead of just rejecting outright expensive treatments without any explanation.
PhRMA also criticised MOH rules for six or 12 months of post-marketing surveillance data prior to listing on the formulary, without any mechanism to ensure that patients who benefited from the medicines during local clinical trials maintained access to those treatments during this period.
“If local clinical trials have been completed for a product, it should be automatically listed on the national formulary to enable patients who were on the treatment to continue receiving the product after the clinical trial is complete.
“A policy is needed to bridge the gap for patients from the end of a clinical trial to the listing in the formulary,” said the US pharmaceutical lobbying group.
PhRMA said its 34 member companies hope that sufficient financing is provided by Malaysia to ensure that more patients can receive innovative medicines in as timely a manner as possible to achieve better health outcomes.
“We hope that short term measures, such as cost containment policies, do not become a barrier to access and the government considers fair mechanisms to value innovations that are proven to raise the standards of care in Malaysia.”
For several years now, PhRMA has been calling on the Trump administration to address discriminatory market access practices abroad that purportedly free ride on American innovation and put US jobs and exports at risk, especially in Malaysia.
PhRMA has again called this year for Malaysia to be designated a “Priority Foreign Country” for denying sufficient protection of US intellectual property rights and fair market access. The Priority Foreign Country listing is considered the worst classification. The other listings are Priority Watch List, Watch List, and Monitoring. Malaysia has been classified as a Watch List country — meaning it has been recognised as having “serious intellectual property rights deficiencies” — since 2005.