Key Trends in Life Sciences Compliances to Watch out for in 2022

Regulations requiring price transparency will continue to proliferate. In the US, transparency standards began with restrictions on spend transparency, which were adopted with the goal of lowering prescription prices.

Fremont, CA: Pharmaceutical corporations will continue to focus their marketing efforts—and dollars—on patients rather than healthcare providers. The current regulatory framework aims to protect patients by controlling connections between drug companies and clinicians. Manufacturers are increasingly looking for ways to circumvent physicians and communicate directly with patients as rules get more stringent.

Regulators Look Abroad

Countries are increasingly borrowing ideas on transparency regulation from one another. Many countries outside the US have more stringent spending transparency reporting requirements, and we should expect some of these regulations to be incorporated into US legislation. Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), for example, have proposed requiring pharmaceutical companies to reveal donations to tax-exempt patient advocacy organizations. Similarly, it would not be remarkable if the US adopted French legislation requiring payment to social media influencers to be reported.

Price Transparency

Regulations requiring price transparency will continue to proliferate. In the US, transparency standards began with restrictions on spend transparency, which were adopted with the goal of lowering prescription prices. Rules requiring openness on amounts spent on meals for doctors, for example, did not result in lower prices. As the next most potential path for influencing drug pricing, governments have turned to price transparency rules. Price transparency laws are currently in existence in 18 states, with 17 more proposing legislation. It would be surprising if none of these figures would climb in 2022.

Unforeseen Consequences

In 2022, the unexpected repercussions of price transparency rules should start to emerge. Pharmaceutical businesses must provide information about their marketing operations under price transparency laws in at least seven states. Pharmaceutical companies have been hesitant to provide this information publicly for fear of handing over important commercial insight to their competitors. We should start looking into whether that provision or others like it have any unforeseen repercussions on market behavior in 2022.