CLSA in STAT: Life sciences industry rallies behind Calif. bill to prevent a nightmare scenario for clinical research

By Rebecca Robbins | STAT News
Sept. 20, 2018

SAN FRANCISCO — Drug companies here are rallying behind legislation that they say would fix a state consumer privacy law that threatens to jeopardize the integrity of clinical trial results and drive scientists out of California.

The bill, called SB-1121, would prevent patients from accessing and deleting some of their data from clinical trials. The idea is to make sure that clinical trial participants can’t use the consumer privacy law to prohibit their data from being used by researchers, or to find out if, say, they’re receiving an active treatment or a placebo.

The California Consumer Privacy Act, which California Gov. Jerry Brown signed into law this past June, aims to give consumers more control over their online data, by empowering them to find out what personal information companies have gathered about them, demand that that information be deleted, and block companies from sharing that information with third parties.

The CCPA is slated to go into effect at the start of 2020. It was inspired by the 2017 Equifax data breach that exposed sensitive data about millions of Americans, according to Paul Payne, a spokesman for state Sen. Bill Dodd, who introduced an early version of what eventually became the CCPA.

Despite good intentions, biopharma representatives say, the law was flawed, because it didn’t carve out an exception for clinical data.

“If state law makes it impossible to conduct a scientifically valid research study that complies with federal regulations, then federal research dollars and private research grants will not be awarded to California researchers,” Jimmy Jackson, chief policy officer for the California drug industry trade group Biocom, wrote in a recent letter urging Brown to sign SB-1121.

Observers say Brown is expected to do so.

Trade groups for the life sciences industry have pushed for the clinical trail data carve out in SB-1121. Among the groups that signed a letter requesting that and other changes to the CCPA were the California Life Sciences Association, the International Pharmaceutical and Medical Device Privacy Consortium, and AdvaMed (which represents the makers of medical devices and software). PhRMA and the Biotechnology Innovation Organization backed SB-1121, too, according to Brett Johnson, the CLSA’s senior director for policy and regulatory affairs.

This week, the CLSA started buying digital ads on social media and other websites as part of a broader campaign to try to convince California residents to urge Brown to sign the bill; it plans to run those ads until Brown makes a decision.

“While we’re optimistic that it will get signed, we do think that this is a big enough concern, with potentially substantial ramifications for research in the state, that [we’re running the campaign] because we just can’t take that chance,” Johnson said.

The CCPA only applies in California, but it’s expected to have ripple effects across the country, if legislatures look to the state as a bellwether as they draft their own consumer privacy laws.

SB-1121 is what’s known in policy circles as a technical cleanup bill, making a number of assorted tweaks to the CCPA. Two of the changes passed by the legislature are of interest to drug companies.

One change makes clear that the CCPA won’t apply in cases where the federal health privacy law HIPAA is already in play.

The other relevant tweak carves out an explicit exemption for clinical trial data, excluding it from the personal information that consumers will be able to access and delete under the CCPA. The original version of the law wasn’t meant to cover drug studies.

But drug makers wanted a specific exemption for clinical trial data, to send a signal to researchers and investors that a nightmare research scenario wouldn’t materialize that could potentially invalidate a company’s clinical trial results and slow the development of a drug.

Johnson said he’s heard from drug companies that had a more mundane concern about the CCPA, too. Some worried that the contracts they sign with contract research organizations running clinical trials in California might not comply with the original version of the CCPA. SB-1121 is expected to alleviate that worry.

Although consumer advocates resisted some of the drafted changes, SB-1121 took a relatively easy path through the California legislature; not a single state lawmaker voted against its passage. And observers see no reason to think Brown won’t sign the bill before the Sept. 30 deadline. Criticism of the bill that passed the legislature has been mainly limited to those who say it doesn’t do enough to make a range of fixes needed to improve the CCPA.

The federal registry lists about 8,000 clinical trials that are up and running or recruiting patients in California. The actual number is likely higher, because Phase 1 safety trials don’t have to be registered.

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