Therapeutic Advertising Pre-Vetting System (TAPS)

Therapeutic Advertising Pre-Vetting System (TAPS)

Don t be Complacent Direct to Consumer Advertising is always under the microscope. It is never off the Radar of opponents. The Medicines Act revision is another opportunity for opponents to point the finger. There is no room for complacency. You need to show that you are advertising responsibly. Every upheld complaint, or Commerce Commission action can, and will, be held up as evidence. Never let your guard down. Be extra careful that you comply.

TAPS Self Regulation What does it mean? Instead of having a government regulatory agency approving advertisements TAPS provides advice to ensure your work complies with Regulatory and Code requirements You are very much part of it

TAPS Provides: Media acceptance Media assurance Advertisers own the responsibility for what they claim in an advertisement

Why Self Regulation? Adopted by Industry to avert another level of Regulatory control The Advertising Standards Authority (ASA) and ANZA convinced Government that they could run a competent self regulatory system

TAPS Adjudicators TAPS Adjudicators are part of the Self Regulatory System: Working with Industry Helping achieve compliance Ensuring advertising meets Legal and Self Regulatory Codes 3 TAPS Adjudicators: Peter Pratt Nigel Andrews Maureen Roberts

TAPS Supporting the principles of self-regulation Embodied by the ASA Therapeutic advertisements Cost-Effective and reasonable Consumer protection

Advertising Standards (ASA) Code The Principle Code for Self Regulation Code of Ethics Therapeutic Products Advertising Code - covers: Dietary Supplements All Medicines Medical Devices Code for Comparative Advertising Therapeutic Service Advertising Code Code for Advertising Weight Management - 14 Codes in total!

Medsafe Advertising Guidelines Guidelines on the regulation of Therapeutic Products in NZ Part 7 Advertising of Therapeutic Products Provides a good summary of requirements for Advertising Medicines www.medsafe.govt.nz

TAPS Approvals Why get TAPS Approval? Advertisements in the media require TAPS approval Assurance of compliance even for advertisements not in the media If a complaint is made all advertising is looked at be prepared Including: Websites, brochures, instore promotional material, Pharmacy brochures, supermarket flyers, newspaper inserts, TV, radio and more All highly visible and likely to attract a complaint!

Time is Money A few tips to help you get the best value out of TAPS The more times you come back to us over a job, the more time the job takes This equates to more money you have to pay Remember the service is not free TAPS will give you the best advice to make your advertising compliant By coming to TAPS we assume you are committed to Self Regulating

Time is Money If you are new and uncertain don t be afraid to tell us We will be better able to explain the do s and don ts We can supply you with useful guidelines and material that will increase your understanding If you have particular concerns about an ad, share those with us, it will save time Its very helpful for us to assess your level of understanding Remember we are on your side and prefer to work with you

Time is Money Double check your references before sending them to us Make sure you send the right ones Check that the reference list has the right numbering that matches the number used in the copy Mark up the references before sending to us. This save time and helps us locate the quote quickly It also helps you make sure you have the correct references

Time is money If you have a campaign that uses the same imagery for multiple pieces of POS material Send them all as a bundle, it will save a lot of time and it means you will be able to use the same TAPS number for each piece If you can t do that, send us a list so we know what is coming Save your approval form with the ad in a place where others in your company can access it. We get constant requests for copies, not the best use of our time. It takes time for us to locate them and send them to you.

What makes a product a medicine? A product can become a medicine or a medical device simply by the claims it makes Therapeutic claims require registration as a medicine, or notification as a medical device

Therapeutic Claims: (a) preventing, diagnosing, monitoring, alleviating, treating, curing, compensating for a disease, ailment, defect, or injury (b) influencing, inhibiting, modifying a physiological process (c) testing the susceptibility of persons to a disease or ailment; (d) influencing, controlling, or preventing conception; (e) testing for pregnancy; (f) investigating, replacing, or modifying parts of the human anatomy.

More on Therapeutic Claims: Sec 56 Medicines Act: No person shall publish; cause to, or permit to; be published a medical advert that: Claims to prevent, alleviate or cure any disease, prevent reduce, or terminate any physiological condition - Part 1, Schedule 1 Medicines Act Claims to prevent or cure any disease or prevent or terminate any physiological condition Part 2, Schedule 1 Medicines Act UNLESS it has consent for this purpose

Therapeutic Claims: Complementary products are restricted in the claims they can make Claim + Product = Medicine Be aware - a claim can be: imagery words imagery and words

Industry Codes All Industry Codes apply as well as ASA Codes Industry Codes adopt the ASA Codes starting point All Codes have the Medicine Act requirements as the basis for compliance

SMI Code The revised SMI Code covers - OTC Medicines - Natural Health Products Dietary Supplements included Advertising & Promotion section Contains sensible advice on Multi Buy offers for Medicines

Medicines NZ Code of Practice Covers - Advertising of Prescription Medicines to Consumers & Healthcare Professionals Very high standards New Zealand - One of few countries to allow advertising of Prescription Medicines to consumers Was under threat - MNZ strengthened the Code ensuring very high standards Companies must ensure highest ethical standards Companies must not misrepresent their products Must not act in a manner to bring the Pharmaceutical Industry into disrepute

Pharmacy Pharmacy Council & Pharmaceutical Society have Advertising Guidelines for Pharmacy Addressing issues: - eg One Day internet sites and sales - Pricing, coupons, discounts etc To provide clarity for Pharmacy Advertisers need to be familiar with this

TAPS Guidelines Located in the TAPS section of the ANZA website www.anza.co.nz General Medicines Natural Health Products and Dietary Supplements Cosmetic Medicines, Medical Devices and Cosmetic Consumer Products Medical Device New Guidelines:

Testimonials Testimonials can only be used for Natural Health Products as long as: The claims are in line with permitted claims Testimonial may not be used to make a Therapeutic claim References may not be used to make a Therapeutic Claim Imagery may not be used to make a Therapeutic Claim Testimonial may not be used for Medicine Advertising to Consumers. This is different in Australia! Testimonial may be used for Medicines Advertised only to Health Professionals.

APPROVED Indications for Medicines The Approved Indication is the purpose for use of a medicine Studies cannot be used to extend the approved indication Any extension to the approved indication needs evaluation and inclusion in Data Sheet A new or extended indication = a new unapproved medicine

UNAPPROVED Medicines Cannot be advertised or sold Sale is permitted at the request of a Medical Practitioner for a patient under his/her care The Distributor must supply completed Section 29 returns Where a Pharmacy is the middleman, they must be part of the Section 29 return process No substituting of unapproved for approved medicines on prescription

Medical Devices Must be Notified on WAND Medical Devices Data Base Self declaration Distributor s responsibility: hold evidence supporting intended purpose for use Audited In the event of a complaint - evidence must be produced TAPS Approval inline with the Registered intended purpose for use TAPS Approval is not an evaluation of the evidence Recommend: Distributors join Medical Technology Assn for advice/info & refer to Code of Practice on www.mtanz.org.nz

Labels Dietary Supplement Labels should comply with NZ Dietary Supplement Regulations Check labels on imported products Dietary Supplements cannot make therapeutic claims Labels not considered at issue until a complaint is made for advert & then regulatory action is taken Non-compliant pack shots cannot be used in NZ adverts

Labels Cosmetic labels - treat the same as Therapeutic claims Labelling requirements- less rigorous Topical preparations are considered cosmetic at present All medicines need Minster of Health s Consent for distribution Evaluated for proof of therapeutic benefit, safety & efficacy Labelling for Medicines is agreed on with Medsafe s strict guidelines

TV Commercials The process: - Storyboard - Mandatory Execution - Concept Approval Involve TAPS early Avoid red light issues Claims must be compliant Check storyboard carefully for implied therapeutic claims

TV Commercials Execution of Mandatories: Clarity! Readability! LARGE FONT! Bold Colour contrast! Time on Screen allow reading time (recommend 4 words/second) Consumer feedback: readability & clarity always at issue Use of audio can mean less visuals. Consider the visually impaired and hard of hearing!

Product Classification Be clear about whether the product is: Dietary Supplement Food Supplemented Food Cosmetic Medical Device Medicine Method of Treatment And tell your TAPS Adjudicator Consult the Medsafe website on: - How to classify your product Regulatory Guidelines - Dietary Supplements Medical Devices www.medsafe.govt.nz

Dietary Supplement - Ingredients TAPS approves the advertising claims, but not the ingredients this is your responsibility Ensure daily doses are in line with Dietary Supplement Regulations Ensure your ingredients are not medicines Ensure the active ingredients are tested Ensure your product contains no undeclared medicines

Social Responsibility Remember all these products have High Standards of Social Responsibility ASA Code - All therapeutic Adverts should be prepared with a High Standard of Social Responsibility

Use of References Dietary Supplements References can be used provided they make no therapeutic claims Often references relate to a therapeutic purpose so cannot be used References on Websites which do this have been removed following Medsafe advice Medicines References may be used as long as they do not extend the Approved Purpose beyond that which has Ministerial Consent

Websites used in advertisements The inclusion of a website address or a link to social media The websites and links have to lead to compliant material Considered part of the advertisement Legal precedence The approval is good on the day of issue Subsequent changes, if not approved, render the approval null and void Remember, have an approval updated if changes are made TAPS keeps a print out of the approved material in case of issue

Non Branded Material Dietary supplements Independent articles discussing current research for ingredients - use with caution: - Must not be associated with advert for product containing said ingredients - ie must not appear on the same or adjacent page - Should not be included in websites advertising the product

Mandatory Statements Must be easily readable - or ASA considers them not there Must be horizontal to the advert not vertical (up the side) Are considered legal part of the advert need due prominence in print & TVC Reminder When resizing an advert, the mandatory size may need changing to still be readable

Absolute Statements Be wary of Absolute Claims: eg Worlds Best The Strongest Breakthrough High standard of Social Responsibility applies quantitatively prove the claim is true Therapeutic Products have no room for puffery

Clinical Trials For Non Medicines: This statement implies a clinical purpose not acceptable. Usually large and formulation specific Can mention clinical studies, clinical research Can not mention a therapeutic purpose Can not mention Clinically Proven or Proven in Clinical trials

Medicines Gift with Purchase Free branded giveaways with a therapeutic claim = full advert and require mandatory information Free giveaways should: - be of minimal value - directly relate to the use of the medicine - preferably contribute to the responsible use of the medicine

Helpful TAPS Tips When sending material to TAPS for approval be clear about the job! We need to know: - What it is poster, lightbox, print advert, electronic media, flyer - How it will be used where it is placed - What is the status of the product Dietary Supplement, Food, Medicine etc - PO numbers Get your PO beforehand. We can provide a quote. - Who is responsible person and the company s TAPS registered name - Who is the audience ie Consumers, Health Professionals etc This will help us determine what rules apply or not

More Helpful TAPS Tips - If you are on Pre-Pay do remind us so we can issue the pro-forma invoice - Tell us what size the Advert is for checking mandatory size issues - If you have concerns about the copy let us know this will save time/money - If you ve had a complaint from the ASA/Medsafe and are changing the advert - let us know as much detail as possible This will help us determine what rules apply or not

General Tips - Make sure you have approved copy on hand - It s better to have compliant material that conveys what you want it to - Its handy for those last minute jobs where you get an opportunity because someone else has pulled out, and there is not much time. - We do our best to assist!

Complaints TAPS Adjudicators cannot receive or act on complaints You are responsible for lodging a complaint in the spirit of Self Regulation This ensures an even playing field for Industry

Where to complain Anyone can complain to: - Advertising Standards Association (ASA) - Medsafe Only industry complains to: - Medicines NZ or - Self-Medication Industry Association (SMI) Complaints come from: - Public - Competitors - Health professionals When complaining, competitors need to identify their status as competitors

When you receive a complaint! You must: Justify the claim made in your advert using reliable, robust data Get assistance if needed to provide reliable, robust data Take the complaint seriously flippant responses don t help! A good first step: Withdraw the advert - until the complaint is resolved

Advertising Standards Association (ASA) Check out ASA Complaints Board decisions: www.asa.co.nz/database You can vary your search by decisions, codes, years or keywords most useful!

Useful Medsafe Sites: Dietary Supplements http://www.medsafe.govt.nz/regulatory/dietarysupplements/regulation.asp Medical Devices http://www.medsafe.govt.nz/regulatory/devicesnew/devices.asp Weight Management http://www.medsafe.govt.nz/regulatory/weight/weightloss.asp Introductory Guidance Is my product a medicine? What do I need to do to sell my medicine in New Zealand? Frequently asked questions http://www.medsafe.govt.nz/regulatory/regulatoryguidance/introduction.asp To open click on site, then click Open Hyperlink

Links: Medicines Act 1981 http://www.legislation.govt.nz/act/public/1981/0118/latest/dlm53790.html Medicines Regulations 1984 http://www.legislation.govt.nz/regulation/public/1984/0143/latest/dlm95668.html Medical Devices Regulations http://www.legislation.govt.nz/regulation/public/2003/0325/latest/dlm224223.html Dietary Supplements Regulations http://www.legislation.govt.nz/regulation/public/1985/0208/latest/dlm102109.html To open click on site, then click Open Hyperlink

TAPS Adjudicators Peter Pratt Nigel Andrews Maureen Roberts Ph 04 938 6409 Mob 027 492 1230 peterpratt@paradise.net.nz Ph 09 836 2680 Maureen Roberts Mob 027 0657 9750 Ph 478 7776 nigel@rubicon.net.nz Mob 021 68 77 60 Ph 09 478 7776 Mob 021 687 760 maureenroberts@xtra.co.nz

Thank you!