CHICAGO – A new Chicago city ordinance says pharmaceutical representatives working in the city will have to pay $750 to obtain a city license.
In obtaining the license, individuals must also complete a course prescribed by the city's Commissioner of Public Health and register with the Department of Public Health. Applicants continuing their practice will be required to complete at least five hours of continuing education. Training courses may not be provided by the pharmaceutical representative’s employer.
The requirements would apply to anyone who markets or promotes pharmaceuticals to health care professionals and works 15 or more days per year in the city, said Sarah diFrancesca, attorney at Cooley LLP in San Francisco, who monitors such developments for her firm's Health Care & Life Sciences Regulatory group.
According to a statement from Mayor Rahm Emanuel’s office in October, the reasoning for the ordinance was to crack down on heroin and opioid addiction in the Chicagoland area, which was included in a final report of the Chicago-Cook County Task Force on Heroin.
“The City of Chicago previously filed a lawsuit against five pharmaceutical manufacturers related to opioids in July 2014,” diFrancesca said.
Licensing regulations, such as those now imposed in Chicago and elswhere in the country, seek to regulate interactions between life science companies and health care professionals through representative licensure, disclosing of gifts and transfers of value, and adoptions of codes of conduct, diFrancesca said.
This ordinance isn’t just something new to Chicago. Many states and counties around the United States are putting similar legislation into place.
“SafeRx Amendment Act of 2008 requires pharmaceutical manufacturer representatives in the District of Columbia to be licensed,” diFrancesca said.
Some other relevant state laws include statutes in Massachusetts, Minnesota and Vermont.
According to diFrancesca, D.C. licensure, however, is significantly cheaper than the $750 licensure fee adopted in Chicago.
The Chicago ordinance also provides the health commissioner with authority over pharmaceutical representatives, requiring them to provide information regarding their interactions with health care professionals. This includes logging the number of times health care professionals were contacted, duration of contact, what drugs were promoted, and whether gifts or samples were provided to the health care professionals.
In addition to pharmaceutical representatives, the ordinance requires the commissioner to produce a list of ethical standards for the representatives. Pharmaceutical representatives are not allowed to: engage in deceptive or misleading marketing of the drugs they are promoting or selling; use forged credentials or licenses saying they can practice medicine or pharmacy; or attend examinations without the consent of the patient.
These requirements are incorporated into the rules and on the city’s website.
Anyone not complying with the new ordinance is vulnerable to disciplinary action.
“Pharmaceutical manufacturers and their employees must ensure strict compliance with the ordinance and any regulations that are issued,” diFrancesca said. “Enforcement by the city could result in fines of $1,000 to $3,000 per offense, where each day that a violation continues constitutes a separate and distinct offense.”
The ordinance takes effect on July 1, 2017.