Massive Reforms for Pharmaceutical System Proposed

The US/Canadian Pharmaceutical Policy Reform Working Group proposes universal drug coverage and ambitious reforms to the pharmaceutical system

Shannon Peters
18
780

The US/Canadian Pharmaceutical Policy Reform Working Group recently published seven proposed reforms to address dysfunction in the countries’ pharmaceutical systems. The Working Group was co-chaired by Adam Gaffney, instructor in medicine at Harvard Medical School, and Joel Lexchin, professor emeritus at York University. The prescriptions for reform, recently published in the British Medical Journal, call for more public funding for pharmaceutical development and regulation. The Working Group also argues that the only way to succeed with the needed reforms is for the US to transition to a universal single payer system, which Canada already has.

“Our pharmaceutical systems are broken, and only fundamental reform can ensure universal access to safer, more innovative, and more affordable drugs,” write the authors.

Photo Credit: Flickr

The authors note that the pharmaceutical systems in the US and Canada “are mired in dysfunction.” The practice of charging market value for medications means many people cannot afford prescriptions that are vital for their health. Additionally, the authors argue that despite numerous new medications coming to market, “the industry’s overall rate of real innovation remains incommensurate with our vast drug spending.” Therefore, the advocacy group Physicians for a National Health Program encouraged the development of a working group, comprised of doctors, scholars, and advocates, to discuss reforms.

“The working group aimed to craft an ambitious proposal for pharmaceutical reform to set an agenda for the future, including insurance coverage, pricing, drug development, clinical testing, regulatory approval, postmarketing monitoring, and promotion,” write the authors.

The Working Group proposed the following reforms. These proposals are based on the assumptions that medical needs (not financial incentives) should determine medication access, medications should be affordable, and the human right to health should be prioritized over intellectual property rights.

Access to Prescription Drugs: It is estimated that 28 million people in the US do not have health insurance and 3.5 million people in Canada do not have prescription drug coverage. Even when people have coverage, copayments and deductibles still act as financial barriers to accessing needed medications. Therefore, the Working Group proposes a universal, first dollar coverage of all medically necessary drugs. They suggest that each nation develops a list of medications that improve length or quality of life that would be fully covered. If multiple similar medications are available, the medication that is safest, most effective, and cheapest would be covered. If someone is allergic to medication on the list, an alternative would be covered.

Drug Prices: US and Canada are among the highest spenders on outpatient drugs. This spending is due to higher drug prices, not higher usage, and research and development costs do not account for the exceedingly high prices. To change this, the Working Group suggests that a public agency negotiates with manufacturers to set fair drug prices. If such negotiations are unsuccessful, they recommend that the government be able to implement a compulsory license to permit generic manufacturing. If this also fails to reduce the cost of a drug, then there should be funding for public manufacturing of these drugs.

Preclinical Drug Development: The Working Group proposes that the Bayh-Dole Act of 1980, which allowed publicly funded researchers to patent their discoveries, be repealed so that publicly funded drug innovation remains in the public domain. They also recommend greater restrictions on patents for privately funded innovation: me-too drugs or minor changes to existing drugs (e.g., combinations of existing drugs, drug delivery systems) should not be patented. As these patent restrictions may reduce incentives for industry to engage in drug innovation, the Working Group suggests that the US National Institutes of Health (NIH) and the Canadian Institutes of Health Research (CIHR) create institutes for prescription drug development.

Clinical Testing: The authors write, “Industry-sponsored clinical trials have sometimes used unsound methods and reported incomplete findings, calling into question the interpretability, and sometimes the veracity, of their conclusions on safety and efficacy.” In response, the Working Group calls on drug regulatory agencies to increase their standards for drug effectiveness and safety. Trials should also compare new drugs to existing ones, rather than to placebo. Additionally, the new institutes that would be developed in the NIH and CIHR could also fund and oversee drug trials.

Drug Approval Reform: “Canadian and US regulatory agencies too often allow unsafe drugs to reach the market and inadequately monitor them after approval,” state the authors. In 2014, 69% of drugs that were submitted to the FDA received “expedited review” status, despite the majority of studies showing that shorter review periods lead to more problems. Thus, the Working Group proposes that regulatory agencies be fully funded by the government rather than industry. They also call for steep reductions in how many drugs are offered an expedited review. Additionally, no one with financial ties to industry should be able to vote on a drug’s approval.

Postmarketing Surveillance: After a drug has been approved and goes to market, postmarketing studies are essential to continue to monitor the safety and efficacy of the drug. However, the Working Group warns that such studies “should not be an excuse for weakening preapproval safety requirements.” They call on regulatory agencies (e.g., FDA, Health Canada) do more to enforce mandatory postmarketing studies and take action when a medication is found to be unsafe. These agencies should also receive more funding.

Promotion: Drug promotion to physicians and direct-to-consumer advertising are incredibly costly. Additionally, drug marketing is often misleading or false, and the FDA and Health Canada do not have the resources to review all marketing materials. To fix these problems, the Working Group suggests that regulatory agencies receive more resources to engage in promotional reviews and impose larger sanctions when the promotional material is misleading. The authors state that they are in favor of ending direct-to-consumer advertising, but recognize the barriers to this in the US due to commercial speech rights. However, they recommend that tax deductions for promotional activities are eliminated. Lastly, they propose that licensing authorities do not accept continuing medical education credits from industry-funded sources, as these can be biased and promote misinformation.

The authors posit that the above changes would result in overall savings in the US because money saved in reduced drug costs would offset costs of universal drug coverage and public investments. Medications developed under the public domain would also be available to be produced generically across the world, which would be “a major advance for global health.”

The authors summarize:

“Our proposal calls for a fundamental reorientation of drug policy: it would make drugs more affordable for patients and society, promote innovation, strengthen efforts to assure the safety and effectiveness of medications, and upgrade the evidence available to prescribers and the public.”

The authors note that their reforms would “face formidable political opposition” from drug firms. However, most Americans support government action that would result in lower drug prices, and most Canadians want universal pharmaceutical benefits. Therefore, there is substantial public support that could be harnessed to make the massive changes suggested by the Working Group to the US and Canada’s pharmaceutical systems.

 

****

Gaffney, A., Lexchin, J., & US, Canadian Pharmaceutical Policy Reform Working Group. (2018). Healing an ailing pharmaceutical system: Prescription for reform for United States and Canada. British Medical Journal361, k1039. doi:10.1136/bmj.k1039 (Link)

Previous articleIs Psychosis Natural?
Next articleThe Psychological Effects of Being Separated From Your Child
Shannon Peters
MIA-UMB News Team: Shannon Peters is a doctoral student at the University of Massachusetts Boston and has a master’s degree in mental health counseling. She is particularly interested in exploring the impacts of medicalization and pathologizing the experiences of individuals who have been affected by trauma. She is engaged in research on the effects of institutional corruption and financial conflicts of interest on research and practice.

18 COMMENTS

  1. There will be no reforms in pharmaceutical practices in the US. In my mind’s ear, I can already hear the conservative pundits roar about how medicine’s real goal is to enrich manufacturers and other upper level providers (not to benefit the health of those who aren’t billionaires). This will be topped off with the usual conservative platitudes about citizen responsibility. That this is so your health care providers can be totally irresponsible, gaining enormous profits at your expense, will not be mentioned (except for more platitudes about how profits going into the pockets of investors and executives will automatically lead to miraculous advances in human health- the greater the profit, the more benefits will automatically accumulate without thought or effort on anyone’s part).

    • We’ve got, beyond even that in the “mental health” field, a massive iatrogenic damage problem in the medical field, and I believe this report only scratches the surface of the extent of the problem. Not only does the selling and development of medicinal drugs need more regulating, but doctors need to refrain from the over prescription of medicines that in some fashion or other may prove toxic. Increasing sanctions? When drug companies have received some of the stiffest civil penalties in history, and still they make too much to be significantly affected, good luck with that. I don’t feel these reforms go far enough, however, in this case, any reform is going to go further than no reform. Change has long been needed. These drug companies also hire full time lobbyists, and getting anything done, given that kind of defense of their profit margins, may prove very challenging indeed.

    • Give them some credit, those aren’t the arguments they use, rather it’s that high prices and patenting “me too” drugs are necessary to fund further research (even though most if not all of them spend more on advertising than they do on R&D–so why not undo the legalization of DTC [direct to consumer advertising]; they would save all that money and suffer no comparative disadvantage because it would still be a level playing field for all of them).

      • Best of all is when there are no more consumers. I am nearly 70 and have had no need of any doctor for the last 23 years, bar one pap smear I had done out of curiosity. When everyone, who is humane, can handle their health as to not fall ill, then the ultimate in reforms is right there. See my answer to Frank above.

      • Fundamental reorientation of drug policy is desperately needed, especially since death by medicine is the number three killer of Americans.

        https://www.bing.com/videos/search?q=death+by+medicine&view=detail&mid=6A817D537A935CF397166A817D537A935CF39716&FORM=VIRE

        Drugs do need to be made more affordable, I agree with truth793810 that making DTC pharmaceutical advertising illegal again is a must and would reduce costs. I’m not an expert on “commercial speech rights” but given the reality that the pharmaceutical industry’s “marketing is often misleading or false,” this might negate that so called “right.”

        I don’t see how these proposals would necessarily promote innovation, but historically a competitive free market is what promoted innovation. The current pharmaceutical cartel, which is the opposite of a competitive free market, of course does the opposite. So breaking up the pharmaceutical cartel into much smaller companies would promote innovation.

        Definitely the FDA has failed us, and there is a need to “strengthen efforts to assure the safety and effectiveness of medications, and upgrade the evidence available to prescribers and the public.” I do think the internet and patients/independent psychopharmacology researchers have done a much better job of this, than either the pharmaceutical or medical communities, or the FDA.

        I do hope to see timely and massive reforms of the pharmaceutical/medical industrial complex. Such reforms are long past due.

        • A truly free market wouldn’t force people to buy shoddy or harmful products. Or even quality, helpful products they prefer not to.

          And such massive, wide-scale deception of the public should be punishable with prison sentences for the advertising execs. Like the one Bernie Madoff received. That kind of crooked!

  2. “Drug Approval Reform: “Canadian and US regulatory agencies too often allow unsafe drugs to reach the market and inadequately monitor them after approval,” state the authors. In 2014, 69% of drugs that were submitted to the FDA received “expedited review” status, despite the majority of studies showing that shorter review periods lead to more problems. Thus, the Working Group proposes that regulatory agencies be fully funded by the government rather than industry. They also call for steep reductions in how many drugs are offered an expedited review. Additionally, no one with financial ties to industry should be able to vote on a drug’s approval. ”

    These are not just problems, they are crimes. They are crimes that have killed thousands of people. 50,000 people died last year from Opiates, many thousands of which were related to prescription drugs like, Xanax, and Fentanyl, that should have never been approved. Drug companies, have known full well of the dangers of these medications, and they really don’t care, as long as they make billions. They are addicted to money, watch them go into withdrawals, when that money is taken away from them.

  3. Thanks, Shannon, for interesting article. Good for the US/Canadian Pharmaceutical Policy Reform Working Group for advocating for much needed reform in the pharmaceutical industry. Certainly there will be resistance from the Big Pharma but the public wants this. Single-payer system allows for better negotiating of prices and forces pharmaceutical companies to lower their prices. This is going to take the public to pressure their legislators to advocate for this. It is the right thing to do. I spent this weekend for a class looking at financial statements for one pharmaceutical company. They spend millions for lawyers to defend intellectual property rights. Corporate self-interest should not be driving drug prices, need should. You need the government to help regulate Big Pharma, because they have no real self-interest in doing it themselves. Financial loss for Big Pharma, oh, well. They will survive and people will be better off for it.

  4. The biggest reform that is needed all over the world is the complete legalisation of all drugs (and freedom to choose or not choose) which are currently prescription only. There is this myth that if this is done, society will be in chaos. This is not true. There are plenty of places in my country where medical shops don’t usually ask for a prescription (thank god! But it seems the influence of “developed countries”, BS rules and regulations will slowly change this [and it’s already happening]). But most people don’t irresponsibly put drugs in their body that they don’t need. Why should everyone suffer for some irresponsible addicts who will misuse them or people who aren’t sensible enough to do their own research? If such legalisation will be done, there will be a few individuals who die, which the media and proponents of pharmaceutical control will highlight, whilst neglecting others who are held hostage by their system.

    One can always read about the effects of drugs and ask people who have used them regarding their consequences, positive or negative. One can also consult people who are knowledgeable in chemistry, pharmacology, biology etc. (even medical doctors and pharmacists). These options are always there. But one should not have to be forced to rely on behavioural labelling, controlling and people-trapping organisations, hospitals and people in professional roles.

    There are plenty of people who are either taking psychotropic drugs, or who have to continue taking them till the withdrawal process is complete, which can take months, if not years. Forcing these individuals to rely on the mercy, charity, indoctrination and control of people who were fortunate (or unfortunate, whatever it is) enough to land into the roles of medical doctors is atrocious (hell, sometimes these individuals don’t themselves know the full consequences of what they’re doling out!).

    Freedom will give rise to more information in the hands of people as well. It will also teach individuals to seek proper information.

  5. The profit motive has no place in health care. Healthcare as a business is motivated to supply the most expensive treatments for the greatest duration. Without the desire to maximise profits Doctors are free to use the best most effective treatments for the least amount of time. And avoid treating people for conditions with no effective treatment or conditions which aren’t diseases at all!