This is by Adam Gaffney & Joel Lexchin:
IT HAS SIX PRINCIPLES:
• Medical needs, not financial means, should determine
access to medications
• Drugs must be affordable to society
• Drug development should be geared toward real innovation
that maximizes population health
• The human right to health16 must take precedence over
intellectual property rights (patents)
• The safety and effectiveness of medications must be
independently and rigorously evaluated
• Comprehensive and unbiased information on drugs should
be available to prescribers and patients."
1.Access to prescription drugs
• Each nation would establish a formulary of all medically necessary 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 without copayments, co-insurance, or deductibles
• When clinically necessary (eg, allergies), non-formulary alternatives
would be covered
2. Drug prices
• Government would negotiate with drug firms to lower prices
• “Compulsory licensing” would allow generic manufacturers to produce essential patented medications if the patent holder refused to offer a reasonable price
• Government would commission public production of essential drugs when price negotiation fails and no reasonably priced generic is available
• New public divisions of the NIH and CIHR would develop non-patented drugs and make them available for low cost generic manufacture.
3. Preclinical drug development
• Preclude patents for trivial modifications of existing agents, and restrict market exclusivity for me-too drugs unless they are shown to be more effective or convenient or have fewer side effects than others in the same class.
• Repeal provisions of the Bayh-Dole Act in the US that allow private firms to obtain exclusive licenses for drugs developed through publicly funded research
• Establish public drug innovation divisions in the US and Canada that would fund and oversee the early stages of drug development
4. Clinical testing
• Require higher standards for clinical trials used in drug approval applications
• Increase the transparency and public availability of (anonymized) clinical trial data
• Publicly fund the majority of clinical trials through new “Clinical TrialsDivisions” of the NIH and CIHR.
5 Drug approval reform
• Full public funding of the drug regulatory agencies, ending their reliance on industry user fees
• Less frequent use of expedited reviews
• Restrict membership on regulatory advisory committees to experts without financial ties to drug companies
6. Postmarketing surveillance
• Enforce requirements to promptly perform postmarketing studies
• Increase funding and authority for regulatory agencies’ postmarketing monitoring programs
• Ensure that regulatory agencies have adequate resources to review promotional materials
• Stiffen sanctions for misleading drug promotion
• Eliminate tax deductions for expenditures for direct-to-consumer advertising and other marketing and, in some cases, exclude advertised drugs from the formulary
• Promote academic detailing in lieu of industry detailing
• Reduce the role of industry funding in continuing medical education and guideline development
"At BMJ: 'Healing an ailing pharmaceutical system: prescription for reform for United States and Canada. BMJ 2018;361:k1039 doi: 10.1136/bmj.k1039 (Published 17 May 2018) (If anyone needs please write off-line).
Hari PS: I fear the formatting of messages here is a matter that I cannot seem to control, as it has a mind of its own..! Sorry. Les if I need remedial teaching show me how...!