The Pharmaceutical and Medical Device Manufacturer Code of Conduct
Date ruling took effect: July 1, 2009
Next date to be aware of: July 1, 2010
What it does: Regulates interactions between drug/device companies and healthcare practitioners, placing restrictions on meeting venues, gifts, meals, and entertainment. It also requires companies to disclose any gifts or payments to healthcare practitioners worth $50 or more. Companies operating in the state of Massachusetts are required to track this data and file annual reports, which will be made public on a state Web site beginning later this year.
Whom it applies to: Any pharma or medical device manufacturers that do business in Massachusetts and/or market to HCPs who are licensed to practice in Massachusetts
Venue restrictions: Nothing in the code prohibits companies from using hotels, convention centers, or special-event venues for continuing medical education or other third-party. It does say that conference venues must be “appropriate and conducive” to education.
Meal restrictions: Drug and device companies are prohibited from directly paying for meals for HCPs at medical conferences or continuing medical education events.
What else it bans: Any entertainment or recreational items of any value given to HCPs, and any giveaways (including pens, mugs, gift cards). Unlike the PhRMA and AdvaMed codes, which exempt educational gifts, the Massachusetts code does not make any exceptions to the gift ban. Drug and device companies are not allowed to reimburse Massachusetts HCPs for travel and entertainment unless services were rendered for the company (speaking/consulting engagements, etc.).
The repercussions: Unlike the PhRMA and AdvaMed codes, the Massachusetts code is not voluntary. Any drug or device company that does not abide by the code will be fined $5,000 for each violation. There are no penalties for individuals such as meeting planners or HCPs.
Heads up: Pharma and medical device companies are required to track any payments to Massachusetts HCPs of $50 or more relating to sales andactivities and report these annually. The first filing will take place in July 2010 and will cover interactions with HCPs from July 1, 2009 to December 31, 2009.
Revised Gift Ban: S 48
Date ruling took effect: July 1, 2009
Next date to be aware of: October 1, 2010
What’s new: Increased transparency, stricter restrictions on gifts, and the inclusion of medical device companies. (The previous version applied to only pharma companies.)
What it does: While previous Vermont law allowed gifts to HCPs valued under $25, the most recently revamped law now prohibits all gifts to healthcare professionals, with the exception of some “allowable expenditures,” and “permitted gifts,” which must be disclosed. Companies must file all allowable expenditures annually with the state attorney general’s office on October 1.
Whom it applies to: Any pharma or medical device manufacturers that do business in Vermont, and/or market to HCPs who are licensed to practice in Vermont
Venue restrictions: The law does not include any restrictions on venues for meetings, conferences, and educational events.
Meal restrictions: The gift ban considers free meals to HCPs <i>verboten</i>.
What else it bans: The law defines a “gift” as anything of value provided to an HCP for free. In addition to food, this includes entertainment, travel, subscriptions, advance, service, and other payments.
What is allowed: Pharma companies are allowed to provide financial support to accredited CME sponsors for educational conferences, and to pay forhonoraria and travel expenses. Also allowed: payments for research projects, salary and expense support for HCPs who participate in certain clinical trials, royalties and licensing fees, and reimbursement for medical device technical training expenses. Prescription drug samples are also considered “allowable expenditures.”
The repercussions: Any company found in violation of the state code can be fined up to $10,000 per incident.
Heads up: Pharma and medical device companies must file by October 1, 2010, for the time period from January 1, 2010, to June 30, 2010. Exempt from disclosure are payments for clinical trials, royalties and licensing fees, and rebates and discounts for prescribed products.
Current Gift Ban and Proposed HF 1641 Bill
Background: In 1993, Minnesota became the first state to ban drug company gifts to HCPs. The current law bans gifts valued at $50 or more and applies to pharmaceutical companies operating in Minnesota and/or marketing to HCPs licensed to practice in the state.
The current law allows: Payment to the sponsor of a medical conference, professional meeting, or other educational program, provided the payment is used solely for bona fide educational purposes; reasonable honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional conference or meeting; and compensation for the consulting services of a practitioner in connection with a research project.
The proposed new legislation would: Clarify the meaning of “gifts”; ban all gifts from pharma companies, as opposed to just those valued at $50 or more; extend the ruling to medical device companies; increase transparency of HCP payments; and clarify reporting requirements.
Requirements for disclosure: The proposed bill would also require that drug and device companies file an annual report with the state’s commissioner of health that discloses all payments, honoraria, reimbursements, and other compensation paid to HCPs or to sponsors of a medical conference, professional meeting, or other educational program. The bill also includes a provision that would require HCPs to report any compensation from drug and device companies.
What would be allowed:
- Prescription drug samples to be distributed to patients for free
- Unrestricted grants to the sponsor of a medical conference, meeting, or other education program, provided the grantor has no influence on content and provided the payment is not made directly to the HCP.
- Honoraria and expense reimbursement to HCPs who serve on the faculty at an education conference, provided the payment is in line with the “standard hourly billing rate” of the HCP.
- Compensation for consulting services of an HCP in connection with a legitimate research project, provided the compensation does not exceed the “standard hourly billing rate” of the HCP.