No. This is unlikely to be acceptable.

• The IFPMA Code prohibits promotion of a medicine before it has received a Marketing Authorization from the local regulatory authorities. The important decision is whether the proposed activity constitutes promotion / advertising, which is not allowed, or the proper exchange of scientific information, which is permitted before marketing authorisation is granted.
• Several aspects suggest that the proposal is in fact promotion. The video presentation concerns an unlicensed medicine. Had it been about, say, diabetes in general it might not have been considered promotional. However trial results will be presented and the fact that it is a trial investigator who will present the information makes no difference. Also just because a trade name is not used does not mean that an item is non-promotional.
• In addition, representatives will be showing the video. It can be reasonably assumed that a representative’s main role is to sell medicines and therefore any activity they undertake can probably be assumed to have a promotional intent – unless the facts disprove that.
• A couple of final points. To whom the activity is directed may be a factor that the adjudication body will consider. This proposed activity is directed at General Practitioners. It might have been acceptable to communicate ‘high science’ to leading academic specialists with an educational, rather than promotional objective.
• Also timing could be important. This proposed activity was to take place in the few weeks before the product was launched and this suggests a promotional motive. Scientific communications that take place a long time ahead of any product launch e.g. during early development stages, are much less likely to be judged as promotional.
• Finally, we have to remember that marketing authorisations are granted at different times, and with different conditions in different countries. Sometimes information may be available across national borders through some channels (e.g. the internet) so it is important to make the intended audience clear if there might be any uncertainty.

Answer C.

• The IFPMA code permits public disclosure of information to stockholders and others concerning pharmaceutical products and often this is required by stock market rules. This press release is primarily about the business importance of the marketing authorisation application for ‘LowSug’ and it would be appropriate to send it to business correspondents.
• If the press release were sent to medical newspapers it might well be seen as advertising the product before marketing authorisation is granted. Nevertheless a different release that concentrated on important scientific data might be suitable for the medical professional press it the information was truly newsworthy from an objective medical viewpoint.
• If the press release were sent to lay newspapers, as for medical newspapers it is likely to be seen as promotion before a marketing authorisation is granted. Additionally it might be seen as promotion to the public of a prescription medicine and this is only permitted in one or two countries.

*1

Advertisements must include the approved name – although this is included in the prescribing information section ‘metoapril’ should be added here. Many countries require the non-proprietary name to appear adjacent to the most prominent display of the brand name.

*2

A claim to be better without being clear about the comparator(s) is likely to be judged as misleading or an all-embracing claim without qualification. The comparator is not clear and thus the claim is also ambiguous. It would be difficult to substantiate such a claim.

A claim to be ‘safe’ is unlikely to be acceptable. The IFPMA code says that descriptions such as ‘safe’ and ‘no side effects’ should generally be avoided and should always be adequately qualified.

*4

Check the Prescribing Information! In fact the maximum dose must be taken in two divided doses (i.e. twice daily) so the claim is inaccurate and misleading

*5

This claims raises the question as to whether metoapril (Cardiohype) is licensed for coronary heart disease (CHD). The IFPMA code requires that claims should not be inconsistent with locally approved product information. The prescribing refers only to it being indicated for mild to moderate hypertension. It seem that the product is being promoted for an unlicensed indication.

*6

The graph raises several concerns.

There really is insufficient information concerning the study for the reader to fully understand the meaning of the data. Amongst other issues, the patient numbers are very small for a mortality study creating uncertainty over how the graph should be interpreted. Again there is the question about whether CHD is a licensed indication. Also some data is missing (for 45 – 60 year olds)

The graph title claims a ‘significant’ improvement. Making a significance claim must mean not only that the data is statistically significant but that, also, it is significant in the sense of being of clinically important.

*7

The cost comparison chart is likely to be considered as misleading. Remember that visuals, as well as text, can represent misleading claims. Comparisons must be fair and compare like with like.

This graph appears to compare the lowest dose of Cardiohype with what may be higher usual doses of competitors. It is not clear whether costs of branded competitors have been used (presumably the costs of cheaper generic versions have not been quoted) and it is also not apparent why a wider range of anti-hypertensive agents has not been included (e.g. diuretics). The basis for cost comparisons should be clear.

The data shown in the graph represents costs at a particular time. Should there be any changes in any of the prices of the products listed then the advertising material must be amended immediately to reflect that change. All information must be accurate.

The table has a suppressed zero in that it starts from $9 and thus exaggerates the visible differences between the prices of the products. Enalapril appears to be nearly three times the price of Cardiohype which is not so. This is misleading.

*1

The basis set out for the invitation suggest that sponsorship to attend is conditional on having prescribed the company’s product and the potential to prescribe more. This is unacceptable.

*2

There is a question of whether the promotional intent and nature of the event is being disguised. The meeting appears to be solely about diabetes whereas a particular treatment will be a major focus.

The Company name is not prominently displayed – the invitation appears to come from a medical academic.

*3

This hotel appears to be extravagant and not conducive to an educational meeting. The IFPMA Code requires that all events must be held in a venue that is conducive to the scientific or educational objectives and purpose.

*4

Barcelona may well be an acceptable venue for an international meeting – but invitations (including visuals) should not emphasize touristic aspects.

There may also be questions about whether international travel is justified for this meeting. From the information we have it appears that this is a genuine international meeting with delegates from many countries.

*5

The program presented gives the impression that the emphasis is not on the scientific program. The IFPMA Code says that no entertainment or other leisure or social activities can be provided or paid for by companies. It is inappropriate to program in leisure time even if the company does not pay – the focus of the meeting must be the science. Insufficient detail of the scientific program is given.

*6

The IFPMA Code stipulates that costs of accompanying persons cannot be paid. It is also inappropriate for companies to arrange programs for accompanying persons

*7

It is inappropriate to link invitations so closely to representatives, whose job is to sell. This creates an impression that attendance is linked to willingness to prescribe the company’s products.

The IFPMA Code requires a legitimate need for the services which must be clearly identified and documented in advance and that the criteria for selecting consultants must be directly related to the identified need.

Although gathering information to support marketing is a legitimate aim of an advisory board the number of meetings and the total number of participants proposed here is of concern. It is very unlikely that this number is really needed to gather the necessary information. The criteria selection (formulary committee membership) cast further doubt over whether obtaining necessary information is really the objective of the meetings.

The fee proposed may be reasonable. Due to competition law considerations, the IFPMA Code, as well as national codes, are prevented from giving precise figures for what constitutes ‘Fair Market Value’. Acceptable fees will vary between countries and circumstances. Nevertheless, at a national level it may be possible to look at code case reports or other guidance to help determine what a ‘fair market value’ for a particular service could be. Also companies may set out internal policies that describe what they believe to be acceptable so these should be consulted.

However, in this case, if the so-called advisory board is, in reality, a promotional meeting then any payment would be seen as a cash payment for promotion. This is of course prohibited.

The balance of the proposed program seems to be on giving information to the participants rather than receiving advice from the contracted participants. It seems that this meeting amounts to paying healthcare professionals to receive promotional (albeit scientific) information. Only a minority of the time allocations is for the company to receive advice. This is unacceptable.

It is acceptable to contract healthcare professionals to speak at company meetings. However there must be concerns that in this case, because only ‘Lowsug’ trialists are invited to give an update on diabetes that the presentation could be disguised promotion.

It is good that the feedback from the participants will be recorded and presumably will be used by the company. However we are not told what use that data will be put to. There is a potential concern that it could be used for selling purposes for the invited participants (i.e. disguised promotion again) rather than as general feedback on marketing strategy. Companies should keep clear and adequate records of the activities that can give a full picture of the arrangements in the event of a query or compliant.

None of the answers is wrong.

However, in the first instance, contacting the medical director or compliance officer of company concerned is recommended. This may well have a rapid effect, providing your case is clear and well presented.

Again, you COULD do any of these.

To some extent your choice will be affected by the national regulatory and legal environment. In most countries the industry code of practice route will be the favored one, assuming that ‘RIVAL’ company is a member of the industry association. It is likely to be relatively quick, the complaint will be judged by independent experts and the company concerned will be required to ‘put things right’.

The answer is B.

A complaint can be made under the IFPMA complaint scheme providing that a ‘RIVAL’ company affiliate is a member of at least one national IFPMA member association or the company global HQ is an IFPMA member. This provides an effective complaint option even if local codes cannot be applied for some reason. It can also be useful where local regulatory and legal options are not viable or appropriate. It does not however cover local companies that are not affiliated to IFPMA in any way.

*1

A medical ‘App’ produced by a patient organisation to aid may well be appropriate for a pharmaceutical company to support by way of a grant. However, in providing this support no company may require that it be the sole funder of a patient organization or any of its programs. Accepting this proposal as offered would, in effect, amount to purchasing the right to be a sole funder of a program and is likely to be ruled unacceptable.

The company should be very cautious about the proposal that the app, when produced, will be offered in other countries. The item will be subject to national codes and regulations and should any item be unacceptable under local rules in other countries the company could be held responsible.

Inclusion of a company advertisement on an App is not in itself unacceptable, but remember that in all except a couple of countries (i.e. USA and New Zealand) advertising prescription medicines to the public is illegal, and any advertisement must comply with all applicable rules and regulations. This proposal suggests the purchasing of advertising space even though it is unclear how much of the requested fee is to purchase an ad and how much is a grant to develop the ‘App’. Purchasing this service should be covered by detailed written documentation.

Remember as well that a company’s support of a patient organization program must be transparent.

*2

Companies may support patient organization meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organization. Despite the aim of the event to support the laudable aims of the patient organization, whether this event falls within those criteria is debatable.

The venue, location and general nature of the event is concerning. The venue is unlikely to be considered as appropriate and conducive to informational communication. Also the hospitality arrangements are certainly not modest.

The IFPMA Code does not specifically cover government officials, although companies will be subject to anti-bribery legislation that does cover them. Also, some national codes may cover interactions with government officials. Nevertheless, companies would be well advised to apply similar criteria to aspects such as hospitality to those it would apply to healthcare professionals. In this proposal the audience includes healthcare professionals and the company’s requested donation will be used to subsidise their attendance, which therefore falls within the scope of the IFPMA Code. The company should decline to sponsor this event explaining the requirements of the IFPMA Code.