Bench Memos

Pharmacists’ Conscience Rights on Trial—The 2007 Regulations

Following up on my introductory post on the ongoing trial in the state of Washington over pharmacists’ conscience rights, I’d now like to present the history and substance of the 2007 state regulations that the plaintiffs—owners of a family pharmacy and two individual pharmacists—are challenging.

Let’s begin with some general background. (Here, as in my previous post, I draw heavily from the facts set forth in the trial brief submitted by plaintiffs’ legal team, consisting of the Becket Fund and the Seattle law firm of Ellis, Li & McKinstry.)

The Washington state Board of Pharmacy has long given pharmacies broad discretion to decide which drugs to stock. Its primary general requirement—the so-called “Stocking Rule”—is that pharmacies maintain “a representative assortment of drugs to meet the pharmaceutical needs of its patients.”

There are over 6,000 FDA-approved drugs, and no pharmacy in Washington (or elsewhere) stocks them all. Pharmacies decide which drugs to stock based on a range of factors—for example, a drug’s cost, its shelf life, customer demand, insurance reimbursement amounts, inventory carrying costs, monitoring and training requirements, and other administrative costs. Some pharmacies also choose to serve a particular business niche (e.g., pediatrics) and decline to stock drugs that fall outside that niche. The Stocking Rule has been on the books for over forty years, and the state Board of Pharmacy has never enforced it to prohibit pharmacies from relying on any of these secular reasons in deciding not to stock particular drugs or categories of drugs.

Because pharmacies stock only a fraction of all FDA-approved drugs, they often receive requests from customers for a drug that they don’t have in stock. When that happens, a standard option is to refer the customer to another pharmacy that can satisfy the customer’s request.

Even when a pharmacy has a drug in stock, it may choose for various reasons (including hassles related to reimbursement and forms of payment) to refer the customer to another pharmacy. The state Board of Pharmacy has never prohibited pharmacies from relying on secular reasons in deciding to refer customers elsewhere even when they have the requested drug in stock.

The right to engage in referrals for reasons of conscience has also long been a recognized part of the pharmacy profession. Conscience-based referrals are permitted by law in the vast majority of states. In 1998 the American Pharmacists Association adopted a policy expressly approving of conscience-based referrals, and the Washington State Pharmacy Association has long endorsed the right.

Notably, the state defendants in this case have stipulated that the state Board of Pharmacy believes that “facilitated” referrals (in which a pharmacy calls ahead to ensure that the nearby pharmacy has the drug in stock)—including for reasons of conscience—“are often in the best interest of patients, … do not pose a threat to timely access to lawfully prescribed medications, and … help assure timely access to lawfully prescribed medications …. includ[ing] Plan B.”

Beginning in 2005, Planned Parenthood began urging Washington governor Christine Gregoire and the state Board of Pharmacy to require pharmacists to dispense Plan B even if they had conscientious objections to doing so. But the state Board of Pharmacy confirmed its support for permitting referrals for reasons of conscience, and the State Pharmacy Association expressed its support for referral for reasons of business or conscience.

Acting at the behest of Planned Parenthood, the state Human Rights Commission informed the state Board of Pharmacy of its view that conscientious objections to dispensing Plan B were a form of unlawful discrimination, and it threatened Board members with personal liability if they voted to protect conscientious objections to Plan B. Nonetheless, in June 2006 the Board voted unanimously to protect conscientious objection by permitting pharmacists to provide timely alternatives, including referral.

Working with Planned Parenthood, Governor Gregoire continued to push for a rule prohibiting conscience-based referrals and to replace members of the Board who wouldn’t comply with her wishes. In April 2007, after Gregoire appointed two new members of the Board recommended by Planned Parenthood, the Board approved the 2007 Regulations.

In the so-called “Delivery Rule,” the 2007 Regulations establish a general “duty” of pharmacies “to deliver lawfully prescribed drugs and devices to patients and to distribute drugs and devices approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies.”

The 2007 Regulations expressly set forth secular exceptions to this general duty. One exception provides that a pharmacy need not deliver a drug “without payment of [its] usual and customary or contracted charge.” The Board has interpreted this exception broadly to protect a pharmacy’s business decision to refuse to deliver a drug—where, for example, the pharmacy has decided not to accept payments from certain insurance plans, refuses all Medicare patients, requires payment in cash, or refuses to accept personal checks.

Another exception provides that a pharmacy need not deliver a drug that it does not have in stock “despite good faith compliance” with the Stocking Rule. The broad leeway that the Board has given pharmacies to rely on secular reasons not to stock particular drugs, or categories of drugs, makes this exception equally broad.

Further, despite never having enforced the Stocking Rule against business or other secular reasons for not stocking a drug, the Board adopted the position that a pharmacy violates the Stocking Rule if, after a patient requests Plan B, the pharmacy declines to stock it for reasons of conscience.

The combined effect of this new application of the Stocking Rule and of the 2007 Regulations means that the state of Washington goes further than any other state in requiring pharmacies to stock and dispense Plan B. (Similar rules in Illinois were struck down as a violation of the Free Exercise Clause.)

Next: Why Washington state’s regime violates the Free Exercise Clause.

Exit mobile version