CLAUSE QUESTIONS GENERAL

Transcription

1 CLAUSE GENERAL 1 4 QUESTIONS What is self-regulation? Why is self-regulation important? What is the aim of the Code? Where does the Code fit in within the UK law? What is the difference between the ABPI and the PMCPA? Why are there requirements within the UK Code that go beyond the UK law and the EFPIA Code? What is the spirit of the Code? What is promotion? Do the requirements of the Code apply to third parties working on behalf of a pharmaceutical company? Is where a journal is compiled, edited and published relevant for on-line journals and what if the audience is only for non- UK HCPs? When a conflict of requirements in different country codes happens the most stringent is always applied. Where is this set out in the ABPI Code and are there any situations where this is not the case? Why does the Code not specifically mention other relevant laws such as the General Data Privacy Requirement? Why are regional public organisations not included in the exemptions for NICE, SMC, AWMSG? Can a company promote to a non-medical prescriber? What about MPs, patient organisation personnel, medical students? Can they attend pharmaceutical company exhibition stands? When referring to general research can companies link to ClinicalTrials.gov? eg provide the number of years of research in a stated therapeutic area and the number of patients involved in trials? Do risk minimisation materials need prescribing information? What are the requirements for materials and activities initiated from teams with global or regional headquarters in the UK which are not directed at UK HCPs? What are the requirements for UK HCPs/ORDMs attending a company organised meeting outside the UK? If medical educational meetings for HCPs require updates or discussion on unlicenced medicines, what considerations should a company take into account? Are patient organisation representatives considered to be members of the public? If a second medicine is mentioned in promotional material for another medicine does the prescribing information for both need to be provided? What is the web address for the MHRA yellow card site? If a company has an advertisement in an electronic journal where the PI is provided via a link and a pop-up appears to notify the reader that they are leaving the journals site, does this mean that the direct single click link requirement has not been met?

2 If the MHRA yellow card address changes how quickly should materials be updated? 5 What is the purpose of abbreviated advertisements? Why are there limitations of the volume of advertising? (Clauses 6, 9.7, 11.1 and 11.2))? 6,9.7,11.1 & What volume of advertising is acceptable on a digital platform? 9.3. What does the requirement that 'the name or photograph of a member of a health profession must not be used in any way that is contrary to the conventions of that profession mean? What activity(ies) are we trying to avoid with this clause? Material relating to medicines and their uses, whether promotional or not, and information relating to human health or diseases which is sponsored by a pharmaceutical company must clearly indicate that it has been sponsored by that company. What is the meant by sponsored? 9 How can photographs of health professionals be used in promotion? The supplementary information to Clause 9.7, Extremes of Format, Size or Cost, that particular care needs to be taken in this regard in the first six months following the launch of a medicine to avoid criticism of the industry. Why is this limited to the first six months following launch? If a dialogue is established upon receipt of a promotional , is there a requirement to provide both PI and an unsubscribe option with each What are the requirements for third parties when declaring sponsorship? 11 Does Clause 11, Distribution of materials, apply to s? What are the expectations with regards reviewing data on file before use? What would be expected in an audit? What Joint Working material requires certification? What materials provided under a MEGS require certification? What material relating to working with patient organisations requires certification? Why do the arrangements for a meeting where a UK HCP is speaking outside of the UK, with no UK delegates and the UK company has no role whatsoever in relation to the meeting or presentation not need certification or examination. Do the requirements of the Code not apply in such circumstances? (Clauses 14, 23 and 27)What needs to be certified or examined with respect to arrangements for HCPs etc who are delivering services under an agreement. 14 When certifying dynamic content what should be considered by signatories? If a template has been certified for employees to complete certain fields eg a meeting invitation where date, venue etc needs to be added, does the final form of each invitation need to be certified prior to issue?

3 14.6 When certifying non-promotional items, materials etc. the Code does not require companies to preserve information indicating the persons to whom it was addressed, the method of dissemination and the date of first dissemination on the certificates or maintain the materials which has been certified, why do the same requirements not apply and what should companies preserve for such materials? What is the difference between examination and checking? Does material have to be certified for each platform it appears on, eg computer, tablet and telephone? Why does the wording for a certificate for the arrangements of a meeting held outside the UK need to be different than the wording for the certification of all other materials, items etc? Is there a limitation on the number of calls a representative can make on a health professional 'HCP'? If so what is the time period? Why is there a limit on the number of calls/visits a representative can make on any HCP? Do representatives have to report adverse events for competitor products? Why are the numbers of calls limited only for prescribers? Should this be 15 expanded to other HCPs who cannot prescribe? 15.6 Representatives must transmit forthwith to the scientific service referred to in Clause 25.1 any information which they receive in relation to the use of the medicines which they promote, particularly reports of adverse reactions. There are other drug safety reporting requirements other than adverse reactions, why is this specifically mentioned? 17 What is the definition of a sample? Why does the Code still refer to promotional aids when product branded items 18 were stopped many years ago? Can companies provide project managers or management consultants as a service provider in the delivery of a MEGS? 19 Do medical and educational goods and services (MEGS) need to be made available to all who request them? Do the financial arrangements for joint working need to be included in the 20 Executive Summary? Can any non-monetary item be provided at meetings? Why is there no separate clause for medical education? Can a pharmaceutical company run a medical educational meeting which is wholly non-promotional, 22 even if a company medicine is mentioned? What is an acceptable number of company attendees to advisors at an Advisory Board Meeting? Do the requirements for consultants apply when contracting with patients, 23 journalists etc? Should ToVs related to Homecare be disclosed? Should ToVs to patient organisations be disclosed on Disclosure UK? How should pharmaceutical companies manage healthcare organisations that wish to opt out of disclosure?

4 How should healthcare organisations consisting of one Director (healthcare professional or other relevant decision maker) eg Limited Liability Partnership or Private Limited Company be treated? What should pharmaceutical companies do if a HCP/HCO tells us they donated their transfer of value to a third party, eg a charity, charitable trust, or other institution? What should pharmaceutical companies do if a healthcare professional wishes to disclose some, but not all, transfers of value against their name? What should pharmaceutical companies do if cross-border payments have not been provided by affiliates by end of March? What should pharmaceutical companies include in our Methodological Note? Should pharmaceutical companies disclosure ToVs for market research? What should pharmaceutical companies include in the 'total' column? Where HCOs receive monies from companies should the disclosure be against individual institutions (hospitals) or at a Foundation Trust level? Can companies sponsor patient organisation meetings? Can pharmaceutical companies respond to enquiries from patients? Can companies make press releases available directly to the public via social media channels and websites rather than via a Journalist? What is an expert patient and how do pharmaceutical companies interact with them? Are patient case studies promotional? Why does the written agreement between companies and patient organisations need to be certified but the contract between companies and patient organisations, under which they provide a type of service, doesn t? Can patients attend company meetings? Can patients who have presented at a pharmaceutical company meeting attend the rest of that meeting as a delegate? Clause Companies working with patient organisations must have in place a written agreement setting out exactly what has been agreed, including funding, in relation to every significant activity or ongoing relationship. What is seen to be an 'ongoing relationship'? How is it assessed in order to fulfil this requirement? Can companies use closed user groups, protected accounts? (A protected account is where participants are registered and there is no circulation beyond those individuals). What about paid for postings? When are references and/or links to third party websites in company materials not covered by the Code? Can companies retweet announcements from other organisations? When working with a patient organisation on a project, what is the pharmaceutical company s responsibilities regarding tweets about the project sent by the patient organisation? Is a pharmaceutical company responsible for suggested content when individuals are looking at that company s materials?

5 Does Clause 14.5 of the Code apply to certified tweets ie do tweets need to be withdrawn at 2 years? How can companies manage tweeting at meetings? For example joint events with patient organisations, learned societies, their own meetings? Is it possible to provide the prescribing information as an embedded image in a tweet to health professionals? Can a tweet be pinned with prescribing information? What should be on a check list for social media activities? What is the impact of personalised websites (when dynamic content is selected) on the need to certify the final form? What are the rules for using chat bots etc? Is it acceptable to have both promotional and non-promotional content on a website? Retweets of topics/announcements from 3rd-party personnel/organisations? For example a re-tweet as a simple acknowledgement/endorsement of an announcements/statements (that are not disease specific) from the DH, NHSE and health policy think tanks. What standards should be applied to these retweets? If third parties are likely to Tweet about a company-sponsored event / publication / project, what steps (if any) should a company take to ensure the appropriateness (compliance) of third-party Tweets on that subject? Does this depend on whether the company has collaboration with the third party? Is certification required or can key principles be specified in the agreement to allow the third party to tweet reactively thereby respecting their independence? If a pharmaceutical company chooses a hashtag in order to group Tweets on a certain topic, what steps, if any, should the company take to ensure the appropriateness (compliance) of third-party Tweets using that same hashtag? Does this depend on whether the company has collaboration with the third party? Tweets relating to guidelines eg NICE guidelines, how should these be managed? Does this depend on the nature of the update to the guideline eg NICE guideline on diabetes recommending a particular class? What does 'not necessarily' mean in the supplementary information that sites linked via company sites are not necessarily covered by the Code? Can links be used in tweets? Is it assumed that tweets from congresses are to a protected account (digitally closed group) and therefore to HCPs? Or should it be treated as including the public?

6 28 If a protected account were established by the Congress Secretariat ie those who registered for the congress, and the company tweet are sent out via the Congress Secretariat would this be considered advertising to the public? If patient organisation members attend the majority of sessions at a congress and enter the exhibition hall are they therefore considered differently in the context of registering for a third party congress? Would the protected account need to be a digitally closed group of HCPs? What is the company s responsibility if a HCP in the protected accounts / digitally closed group of HCPs re-tweets? Is there a difference if the digitally closed group was set up via the Congress Secretariat or directly by the company? If a pharmaceutical company sponsors a delegate to attend a congress will it be responsible for any tweets posted by the delegate? Does this depend on whether the tweet relates to a company sponsored session or a plenary session? What are the Code considerations in the use of paid-for postings (sponsored posts) on Facebook etc (paying in order to have a Tweet or Facebook posting highlighted to a defined group of users eg by location, by online profiling information etc?) Could product/studies be mentioned in tweets/on Facebook if the group was a protected account / digitally closed group of HCPs and PI provided? Are tweets on a disease area acceptable if the company only has one product? Is it acceptable to create a call to action from a tweet or other social media, which takes the user to the company website landing page where the HCP and public domains are clearly separated? What is the PMCPA guidance on linking to third party websites from tweets? Is the company liable? (Clause 28.6 states sites linked via company sites are not necessarily covered by the Code but a company site will have an exit ramp to indicate that the user is leaving the company site and being directed to a site which is not that of the company, however in the case of social media there is no exit ramp). Can emojis be used in tweets which are targeted at HCPs via paid for social? When using YOU TUBE, what level of responsibility does a pharmaceutical company have in checking the context in which the posted material/video is placed? How should the company mitigate against the risk of inadvertent advertising to the public? What are the expectations of certification on different platforms and browsers? Is a test site suitable for final form for certification? If so, does the test site need to be retained for the 3 years? Does the certificate require a third signature to confirm that the published site is a true reflection of the electronically certified test site? How should personalised website be approved for final form?

7 Con and Proc If UK HCPs can access an international site and the product is marketed in the UK does it fall within scope of the Code or is it the specific mention of the product being available in the UK and how the product is used in the UK that brings it into scope? Is it acceptable to have a share function for non-promotional content from a website? Does it depend on whether the website has any product information on it separated out from non-promotional resources? Is it acceptable to have both promotional and non-promotional content on a website if clearly partitioned as such? Is it then acceptable to link from nonpromotional asset to a non-promotional part of the website or should such a link be to the landing page? Why does the PMCPA accept anonymous complaints?