PANEL DISCUSSION. Seminar 28 May 2015

Transcription

1 PANEL DISCUSSION Seminar 28 May 2015

2 Question 1 Pre-licence activity - Advertisement and promotion are subject to domestic legislation, i.e. if a product is not registered in South Africa, it cannot be promoted, even if the congress is international in nature, unless exemption has been granted in terms of applicable legislation. Who grants that exemption?

3 Q1 Bernice Grusd PART A CLAUSE 4 Promotion of a medicine must be in accordance with the registration & consistent with the PI A medicine must not be advertised or promoted: prior to registration Exception - application has been submitted in terms of Section 14(3) of the Medicines Act ( old medicine ), which permits its sale, supply and use in South Africa. The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that this does not constitute promotion. The MCC grants that exemption

4 Question 2 We would like to find out if we are allowed to invite staff (Clinical and Technical Engineers) from Government Hospitals for a Product Launch on new technology for Operating Rooms?

5 Q2 Tanya Vogt Different rules apply depending on the primary mode of action of a device or combination device Audience must comprise of persons who require specific information on the device in order to deliver a service to the patient i.e. you must be able to justify why a particular category of person was invited

6 Question 3 Reimbursement - Please can you assist me. I would like to make use of the services of XXX through a number of CME meetings around the country on the topic of reimbursement and the changing climate but my US colleague says its not Code compliant. The reason given was that depending on the content of the talk, it can be seen as offsetting a business cost for the surgeons (it's not really an "educational" talk but more helping surgeons manage his part of their business). Second, sometimes these talks help guide surgeons to submit for higher reimbursement in an inappropriate manner. But in SA, what about patient access?

7 Q3 Nicole Edelstein Rationale for any meeting or sponsorship to attend a meeting is to be transparent, valid and cogent The Code aims to ensure - maximum healthcare benefit to patients No mention of product specifics Providing the required information needed for the funder to make an appropriate decision Reimbursement assists patients more than doctors Evidence-based choices Finances cannot be ignored in healthcare decisions

8 Question 4 Reply paid cards - We have a pharmaceutical client who sends out a postcard DL Size with their new product information that is addressed to either a doctor by name followed by a postal address or pharmacy by name and mailed as a first port of call to the healthcare provider. This means that the address label which is affixed to the postcard will be sent out from our mail house directly to the doctor or pharmacist in question. I wish to point out that it is addressed to a person and therefore it is for the intended recipient. The recipient does NOT HAVE TO RETURN THE POSTCARD VIA POST TO THE SENDER and this must be stressed. I have been asked by my client to clear the confusion around the difference between a direct mail shot and a response mail mechanism.

9 Q4 Nicole Edelstein Clause 9.8 HIGH STANDARDS, FORMAT, SUITABILITY AND ENDORSEMENT BY HCPS Clause 9: Note 2: Reply paid cards Reply paid cards which are intended to be returned to companies through the post must not include matters which relates to a health product which may not be legally advertised to the public. Reply cards may only bear the name of the product. The inclusion of information would constitute advertising to the public.

10 Q4 Nicole Edelstein What restrictions apply if a postcard is addressed by name to a doctor or pharmacy? Do these restrictions differ depending on whether a direct mail shot or a response mail mechanism is employed?

11 Q4 Nicole Edelstein Difference between a direct mail shot and a response mail mechanism Medicine scheduled 2 or higher, this would be in contravention of Regulation 45 The guideline explains this further by advising that reply cards may only bear the name of the product

12 Question 5 Items at conferences and exhibition stands - Can a pharmaceutical company put an interactive programme on an exhibition stand that requires an attendee to make a series of judgements and choices regarding a treatment pathway? When would such a programme become a quiz, if it was not one already?

13 Q5 Bernice Grusd May be regarded as simply educational material, depending on its content it could also be considered to be a quiz and thus subject to the requirements relating to quizzes in Clause Any assessment or evaluation of the delegates decisions may mean that the interactive programme is a quiz. A quiz would be acceptable if it related to the subject matter of the meeting and formed part of the meeting s formal proceedings. Exhibition stands are not considered to be a formal part of a meeting s proceedings.

14 Question 6 I have been asked to sponsor a Specialist Forum meeting. The committee consists of 4 specialists (surgeon, oncologist, radiologist and pathologist) meeting once every 4 months to plan the meetings. I attend this planning meeting to facilitate logistics and have no input into the topic selection. Once the date and topic is selected, I source the venue, catering. The Committee sources the speakers. (No honorarium is paid to these speakers) I print the invitation on the Pharma Company X letter head. This invitation is distributed via two laboratories, to all doctors in the area. I am listed as RSVP, thus I manage RSVPs for catering numbers. XX sponsor and apply for CPD accreditation. On the evening of the meeting, I ensure the attendance register is completed and that CPD certificates are distributed.

15 Question 6 Can the rep sit in the planning meeting? Can the rep print the invites on Pharm Company X letterhead? Can the rep be responsible for the RSVPs? Can the rep attend the meeting? Can Pharma Company X pay for the venue and catering (sponsorship/grant)?

16 Q6 Bernice Grusd The following documentation is advisable A letter of request from the Specialist Committee Signed contract of engagement between the Specialist Committee and the Pharma company Can the Sales Representative sit in the planning meeting? Yes, as they provide no input into the agenda. Can the Sales Representative print the invites on Pharma Company X letterhead? Yes, provided there is full disclosure 18.3 Transparency

17 Q6 Bernice Grusd Can the Sales Representative be responsible for the RSVPs? Yes, there is no unfair or improper advantage to be gained, they are providing reasonable support Can the Sales Representative attend the meeting? Yes, but only as a silent observer Can Pharma Company X pay for the venue and catering (sponsorship/grant)? Yes Clause 15.4 Organising meetings Clause Hospitality/venues of meetings and events

18 Question 6 Hospitality costs and provision of alcohol - What is a reasonable cost of a meal and drinks for an HCP for hospitality at a meeting

19 Q6 Bernice Grusd Clause 19.1 of the Code requires that the costs of subsistence must not exceed that level which the recipients would normally adopt when paying for themselves. Standard operating procedure (SOP) maximum amounts, quantity, costs and for which type of meals

20 Question 7 Meeting venues follow up on the MCA stance with respect to casino venues to host sizeable HCP meetings

21 Q7 Tanya Vogt Template letter shared with EUCOMED available on the MCA website library

22 Question 8 Representatives paying for access to HCPs

23 Q8 Suzette Bezuidenhout No direct payments may be made to Healthcare Professionals for any other services 15.3 Gaining interviews No fee / inducement / donation to gain an interview

24 Question 9 In light of recent amendments to the General regulations published under the Medicines Act (which have introduced CAMs as a Category D medicine which are subject to full product registration), please confirm whether the Marketing Code is applicable to CAMs?

25 Q9 Nicola Brink 18C provides for a Code but does not mandate at this stage membership to the MCA Industry self-regulates This said the HPA have put forward a formal request to the MCA for CAMs to be included as part of the MCA. They have put forward their own Code but will be subject to the general part of the Code as is OTCs, devices etc. It is at the discretion of the MCA board to bring the HPA on board or not. So for now CAMs are not included. They are however subject to 18A, 18B and 22G where applicable.

26 Question 10 It is interesting to note that this organisation HH is advertising 23 CPD points and cash and getaway prizes. Surely this is contrary to the Marketing Code? A discount for early registration is also advertised? And as a health care event it is certainly not in the spirit thereof?

27 Q10 Suzette Bezuidenhout Offering a differential rate for early registration is acceptable however the prizes offered are not aligned to the Code. A complaint can be lodged to address this matter. In the case of the organiser being a nonmember, MCA may consider highlighting the requirements of the Code in writing on behalf of its members Companies should establish the compliance to the Code of an event before sponsoring / aligning with any such events.

28 Question 11 How do we address a concern if the company perpetuating the problem is not a member of the MCA?

29 Q11 - Suzette Bezuidenhout MCA is self- regulating to the members that belong. Only other recourse is MCC or legal.

30 Thank You