The Patented Medicines Price Review Board Proposed Guidelines & the Threat to Treatments for Lung Disease Patients

Looming national changes to drug pricing guidelines may harm Canadian lung disease patients’ access to new and innovative treatments.  In August 2019, the Government of Canada announced amendments to the Patented Medicines Regulations. The changes allow the Patented Medicine Prices Review Board (PMPRB) to mandate lower drug costs by considering new factors during pricing assessment; adding new comparison countries and no longer including higher priced countries such as the United States and Switzerland; and requiring patentees to report additional information. 

On November 21st, 2019 the PMPRB released their draft guidelines on how the regulations would be operationalized. We at the Lung Health Foundation are deeply concerned about the inevitable impact this will have on deterring drug manufacturers from introducing drugs to the Canadian market. The presented guidelines will further stifle innovation, discourage clinical trials, and delay the launch of new treatments in Canada — all things that patients desperately require. 

Our concerns lie in the need for timely access to new and innovative treatments for our patient populations, as well as ongoing access to the medications that our patients currently rely on. This includes ensuring lung cancer patients can access innovative treatments such as precision medicines made possible due to recent scientific advancements.

It also means that patients with chronic diseases such as chronic obstructive pulmonary disease (COPD) and asthma are entitled to be provided access to treatments that are incrementally better than the current options available. These treatments, although not considered breakthrough, can have a significant impact on patient’s abilities to perform day-to-day activities, and live life without unmanageable symptoms and side effects. The lack of consideration of the interests and values of patients, and threat to patients’ access to treatments concerns us. 

With all of this being said, we are urging the federal government to reconsider the proposed guidelines and to engage patients more meaningfully in these discussions. We are certain that developing a framework for reasonably lowering costs, while maintaining a competitive market for global investment is indeed possible, if done in partnership with the patient community. We believe that patients need to be placed at the forefront of these discussions, and should be given the opportunity to actively participate in setting the context and direction of these consultations.