The US election and pharma
This election cycle, there are two
radically different candidates: the magnanimous tycoon Donald Trump
representing the Republicans and the experienced former First Lady, former
Senator, and former Secretary of State, Hillary Clinton representing the Democrats.
After each party's respective national
convention, the candidates released their full political platforms for this
race. How do the candidates line up on pharmaceuticals and healthcare?
Donald Trump
Trump has set his focus on restructuring the
so-called "Obamacare" (the Patient Protection and Affordable Care
Act), but not in all the ways people assume. While other Republicans talked
about repealing Obamacare, Trump wants to focus on reducing the costs of
prescription drugs for the American people through allowing drug reimportation
and increasing the amount of generics available.
Presently, drugs manufactured abroad are not
permitted to be offered for sale in the United States. US citizens have been organising
bus trips and shopping online for drugs in Canada and Mexico, and whereas it is
technically illegal, officials "look the other way" for those with
less than 3 month supplies of most drugs. Trump seeks to remove entry barriers
for drugs produced internationally and would charge the Food and Drug
Administration (FDA) with setting up an approvals process.
The FDA would also be directed to focus on
clearing out the backlog of unapproved generic drugs so they can be approved
for sale to the public. The thought is that citizens would closely pay
attention to the quality of the drug for the price. As a result, drug companies
will have to focus on efficacy and innovation to survive in the free-market.
Hillary Clinton
Clinton has made healthcare and reining in on
the cost of prescription drugs the heart of her campaigns for decades. She made
her first platform appearance in 1993 with the Clinton Health Care Plan of 1993
during President Bill Clinton's first term in office. While the plan was widely
criticised and failed, it encouraged Clinton to hone in her focus.
Like Trump, she plans to place more drugs on
the market to increase competition, drive down prices and allow for Americans
to shop around. Her plan differs in that Clinton cites the lack of oversight on
pharmaceutical companies as the major cause of the inflated price of drugs.
Her plan would require manufacturers to
reinvest a percentage of their revenues into additional research and
development or else they will be ineligible to receive future federal funding.
The most interesting aspect of her platform
is her plan to regulate direct-to-consumer (DTC) marketing and advertising by
pharma companies. A practice that is banned in many countries, Americans have
seen a 60 percent increase in the frequency of drug commercials on television
between 2012-2015. It is not uncommon to see a commercial for Cialis or Humira
during daily watching, especially with sporting events. In 2015, drug companies
spent $5.2 billion dollars in ads.
Clinton would charge the FDA with regulating
these ads and requiring companies to pre-clear them before releasing them to
the public to ensure that the risks and side-effects are clearly communicated.
Finally, she would decrease a drug's
exclusivity period from 12 years to 7 years; prioritise approvals for drugs and
biologics with little-to-no competition; and allow drug reimportation for
individuals.
Medicare
Both candidates also agree that Medicare
should be allowed to negotiate special prices and foster cost-savings for the
struggling social program.
Medicare Part D (also known as the Medicare
prescription drug benefit) is a federal program that subsidises the costs of
prescriptions and insurance premiums for Americans that receive Medicare
benefits. Medicare Part D's mission is to get necessary prescription drugs into
the hands of those who are low-income, disabled, and/or senior citizens.
Since Medicare was overhauled by the Medicare
Modernisation Act of 2003 (MMA), candidates and legislators alike have
attempted to require drug companies to offer different pricing to the program
than what is offered the general public and average insurance companies.
Three provisions of legislation have been
brought before Congress and all three provisions have either failed in
receiving a majority or were unilaterally struck down.
Summary
Despite the media portrayal of a fiercely
partisan election, both candidates want to focus on similar topics in the
pharma industry. Both Clinton and Trump understand Americans' struggles with
affording medication and treatments that are necessary for survival or make a
world of difference for patients.
They also understand that in allowing for
Medicare to negotiate drug prices, there are significant savings that can, in
turn, be invested into other social programs or the expansion of Medicare
itself. Both want to see healthcare providers be more transparent about actual
costs and want to empower citizens to have more choices with more competitive
options available on the market.
Where they differ lies with their plans to
achieve these goals for the American public. Trump will enact reimportation
with safety standards and Clinton will focus her attention on overhauling the
drug industry as a whole by implementing a revenue-to-innovation ratio for
companies that want to continue to receive subsidies, funding, and tax breaks.
This election will certainly have a major
impact on the future of healthcare and pharma, perhaps to an extent that the
United States and the world haven't seen in a very long time.
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