Prescription for Reform
Prescription for reform for US and Canada
The US and Canadian pharmaceutical systems are dysfunctional—costs are expensive, commercial goals distort drug development and misleading promotion fosters misuse. The industry’s pricing practices tend to charge whatever the market will bear, especially in the US. Further, commercial goals distort drug trials, research priorities and drug regulation.
While many recognize the need for reform, proposed remedies fall short in achieving the fundamental changes required. Hence, this research team proposes the following recommendations:
Access to prescription drugs
If agents with equivalent efficacy and safety were available, only the least expensive would be included, all residents would have full coverage for all formulary medications and when clinically necessary, non-formulary alternatives would be covered.
Government would negotiate with the drug companies to lower prices. Generic manufacturers would produce essential patented medications if the patented companies refuse to offer a reasonable price and government would commission the public production of essential drugs when price negotiation fails.
Preclinical drug development
Patents for trivial modifications to restrict me-too drugs and establishes public drug innovation divisions.
Higher standards for clinical trials used to approve drug applications are required; as is greater transparency and public availability of clinical trial data
Drug approval reform
Full public funding of the drug regulatory agencies is suggested, as well as less frequent use of expedited reviews and membership restriction on regulatory advisory committees to those without conflict of interest.
Requirements to promptly perform postmarketing studies is enforced. Funding and authority for regulatory agencies’ postmarketing monitoring programs is expanded.
Regulatory agencies are ensured adequate resources to review promotional materials, sanctions for misleading drug promotion are strictly enforced, tax deductions for expenditures for direct-to-consumer advertising are eliminated. Advertised drugs may be excluded from the formulary. Academic detailing is promoted in lieu of industry detailing, and the role of industry funding in continuing medical education and guideline developments is reduced.
The proposed reforms are important as cost-related non-adherence to medication in below average income in Canada and the US are high relative to other countries. Although there are barriers to overcome to achieve the proposed changes, 91% of Canadians support a universal pharmaceutical benefit. There are remarkably popular mandates for the reform. The research team hopes that “the proposal to provide a blueprint for reform that anticipates—and may kindle—transformative changes in our nations’ pharmaceutical systems.”
- Marina Kwak
and J. Lexchin.BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1039 (Published 17 May 2018)Cite this as: BMJ 2018;361:k1039