As the pharmaceutical industry transitions from the Trump to the Biden era, what regulatory changes can be expected and how will a new approach to healthcare policy affect the sector?
Words by Isabel O’Brien
When a new state leader is elected, having triumphed on the campaign trail and won the right to represent their nation, there will always be advocates and opposers. These will exist in varying extremities, both in the public that voted for them, and also for the industries that will operate under them, based on the new leader’s objectives and outlook on public policy.
The election of President Joe Biden is no exception. With the nail-biting race and election, characterised by high emotion, controversy, and a global pandemic, stability and recovery will no doubt be a critical and popular agenda. However, when the dust settles and COVID-19 is no longer a key prioritisation, what action will this administration take in the pharmaceutical realm and how will the industry fare under the rule of the new elect?
What’s the forecast?
As with any fresh political chapter, forecasts are in their infancy and not all outcomes are possible to predict.
Nevertheless, as William Soliman, CEO, Accreditation Council for Medical Affairs (ACMA), stipulates, while President Trump was a new face on Capitol Hill, “President Biden has been part of the fabric of Washington D.C. since the early 1970s and is therefore a more ‘predictable’ leader for pharma.” This political track record allows for more precise benchmarking of the policies that will be advanced under his leadership.
Having served as President Obama’s deputy and played a leading role in passing the Affordable Care Act (ACA) in 2010, President Biden will likely seek to increase access to healthcare in the US.
“Being one of the frontiers in the launch of this plan, the Biden team has proposed to bring in more benefits within ACA,” says Rangaraja Konar, Business Analyst, Global Pricing Innovations. “In sectors like pharmaceutical, medical devices, and diagnostics, this would create a positive impact. With more people getting covered under the scheme, there would be a subsequent effect on increased access to drugs, devices, and diagnosis.”
Healthcare executives cannot simply dust off their Obama-era playbooks
With the number of uninsured US citizens decreasing from 60 to 27 million in the last 10 years since the ACA’s creation, further expansion of this scheme will be a step towards creating a fairer and more inclusive health landscape, which is an agenda not only shared by pharma, but a pressing priority for them given the health inequities that were uncovered by COVID-19.
Potential challenges
While alignment is evident, the industry can expect challenges to arise too. “Healthcare executives cannot simply dust off their Obama-era playbooks. Biden will assume the presidency in a country that is very different than it was in 2009,” warns the PwC Health Research Institute.
Just as President Trump fired up the conversation about drug pricing in the US, President Biden is expected to review and address how drugs are costed in the country.
“There are chances for the government to bring a price cap, especially to generics and branded generics with reference to the prices in other high-income countries,” says Konar. “Prescription drug reform is another area that this new government is aiming to ponder upon, as almost 20% of the spending done by the national health insurance policy goes for the expenditure of prescription drugs.”
This could require the industry to provide additional evidence to quantify the cost of their innovations and therapies, with medical affairs leading the way in gathering such insights.
“MA teams, especially those with responsibility for health economics and outcomes research functions, will be more involved in gathering data and helping to collect patient reported outcomes and pharmacoeconomic research to support the prices their companies prefer,” explains a report by the ACMA. With Soliman corroborating: “MA and MSL professionals will be in higher demand to be the primary purveyors of information to the medical community and the wider patient advocacy community as well.”
While the industry will see a calibration in objectives with this new administration, “The healthcare sector might be up to face a mixed bag of impacts on Joe Biden winning the presidential elections,” concludes Konar.
There is not yet a clear indication of whether the administration will be a friend or foe, therefore the industry must keep its purpose front of mind and be ready to ramp up capabilities should further questions be asked and value propositions need to be reconfigured.
