Thank you so much for your answer! @jennifer-carroll

Hey @matt-s17

This question appears to be about a specific product with specific considerations which are hard to anticipate in a general context. Part 3 of the Market Authorization Holder’s (MAH’s) TMA and the information/statements it contains regarding the use of the other therapies will help determine what may be included in a patient brochure. However, in general, a patient should not be exposed to product information for a product they have not been currently prescribed. It may be possible to discuss two products in a single piece if it is clear upfront that the piece is intended to only be distributed to patients currently on both products. An additional consideration is that the content must be within the limitations of the MAH’s TMA. Off-label content from other TMAs would not be considered acceptable. Remember to keep patient information non-promotional and see Q&A 573 for some additional guidance.

We’d suggest submitting for an opinion where you can provide more context for assessment.

Hey @jennifer_bco

The same applies if both therapies are from the same company.

If the sponsor makes the originator, patients on the originator should not receive patient information which speaks to the biosimilar. Patients who are on the biosimilar can receive patient information which is limited to mention of the reference drug product in the exact same context/content as mentioned in part III of the biosimilar TMA.

Hello @kshulist

Enrolling a patient in a support program means that the decision to prescribe the product has already been made (i.e. patient is on the drug). Additionally, given the type of information on the form (e.g., including dosing or monitoring info), the form is not considered promotional but rather administrative in nature. Given these two reasons, indication/FB is typically not required. However, should promotional messaging be added (in the context of an HCP completed PSP enrolment form), indication and fair balance would indeed be required. For a patient completed enrolment form, no promotional messages would be acceptable and therefore the form would be administrative.

Good Morning @munitalp

As the recruitment piece is not target to HCPs, there should be no reference to the manufacturers product, generic name or brand name. Furthermore, the copy should not state the company name. It should be limited to something similar to “a Canadian manufacturer” and “investigating a product”. The trial name, study acronym or logo can be easily linked to the company and products and therefore would also not be acceptable for a clinical trial recruitment piece under the distinction document.

Inclusion criteria which restrict to patients which have had prior treatment with specific products can be referred in a non-promotional way.

Good Morning @tmcd

The PSP is a service offered by the sponsor and for the sponsors brand, it is therefore subject to the PAAB code and would not be deemed exempt.

Hey @NatBourre
We have not received a response at this time. We will reach out to Health Canada to see what the status of this question is. In the interim, we will continue to apply our understanding that this cannot been done as this would contravene consumer regulations.

Hey @Infoseeker, Section 3 of the Food and Drug Act, prohibits advertising to the general public of any drug (whether Rx or non-Rx) as a treatment for a disease listed in Schedule A. Promotion of drugs for prevention of Schedule A does not contravene this section of the Act. The Food and Drug Regulation C.01.004 also states that where a person advertises to the general public a prescription drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantify of the drug. If the brand falls into these categories, then yes, a gate would be required.