CHAPTER 8

Ethics in Sales

Is the sales code of ethics effective in our sales world today, and what implications will current and past changes have on selling in the major markets around the world? This chapter deals primarily with ethics in sales and past indiscretions in the pharmaceuticals industry and what has been corrected to prevent the recurrence of such ethical problems.

There has been vigorous debate over whether codes of conduct are an effective mechanism for controlling pharmaceutical and medical sales promotion. This question also applies to all professional selling in general too.

A series of studies by clinical pharmacologists, conducted between 1985 and 1992,¹ led to the conclusion that the quality of information in advertisements had improved.

The emergence of many other activities, such as symposia, and the activities of pharmaceutical representatives, in particular adherence to the Code, have not been well studied. A small study of pharmaceutical representatives’ presentations to doctors suggested that the information provided was not always accurate or in accordance with the agreed USA Code.

Codes around the world, however, appear to have improved and become more robust since complaints by doctors against pharmaceutical reps were lodged. Telling “porky pies,” as we call this, has been to a degree, outlawed for now.

Code of Ethics in Australia/New Zealand Today

Today in Australia, Medicines Australia (MA), a self-regulating body, based out of Canberra, publishes a list of members and breaches of code of conduct. MA advised me that there were six breaches between 2016/2017 and that four were heard by a committee. For the nonmembers such as generic brand manufacturers, and some drug producers, the GBMA (Generic and Biosimilar Medicines Association), is their overarching governing body, which regulates their ethics and behavior. GBMA is a representative body of generic and biosimilar medicine suppliers in Australia. Its members ensure that all Australians are offered generic and biosimilar medicines of the highest quality in the world together with affordable community health outcomes that benefit all Australians.

It is to be noted that the Surgical Device, Implant, and Capital sectors, represented by the MTAA (Medical Technology Association of Australia), represent the medical technology industry manufacturers and suppliers of nonpharmaceutical products. It is heartening to see such a body of review now available in Australia, following on from the therapeutic Goods Australia (TGA).

Code of Ethics within the United Kingdom

The Ethical Business Practice “code” has been adopted by the ABHI, (Association of British Healthcare Industries). They set the ethical standards for salespeople and for governing ethical promotions by sales professionals and companies. This includes the list of medical products and medical devices. The Code is administered by the ABHI secretariat, comprising the “chairman” and a number of industry representatives. Compliance with the Code and with this Procedure is mandatory for members of ABHI and companies, which, although nonmembers, have agreed to comply with the Code and this procedure and accept the jurisdiction of the panel. “Complaints” this complaint representative body, appears to be a better arrangement as pharmaceutical, medical devices, and hospital products are all covered by the general code of ethics.

It has been said that sponsored private governing bodies that adjudicate complaints from members can be fraught with ethical questions too. To date, the UK code seems to be working efficiently.²

Code of Ethics in the United States

With the latest ethics and compliance programs being implemented by the Pharmaceutical Research and Manufacturers of America and the Office of Inspector General, U.S. pharmaceutical sales representatives are once again working in a stricter ethical environment. Industry consultants report pharmaceutical sales reps are laying new emphasis on relationship building. One of the ways in which some sales reps are working to create and strengthen ties with doctors is by positioning themselves as educational resources on narrowly defined therapeutic areas and complicated diseases.

These guidelines will affect long-term behaviors, and some of the trappings will fall away in the short term, but these new codes will ultimately direct behavior because the public outcry over the perception that “pharmaceutical companies are influencing how doctors prescribe drugs has gotten the attention of the Federal Drug Authority (FDA).”³

Registration of All Implantable Devices

Currently and during my time in the implant surgical business, the patient registration and implant detail registration security was seen as insufficient and easily hacked by outside influences. I refer to “outside influences” as anybody that can easily access, by stealing or hacking, computer patient records from private implant suppliers or agents on behalf of global manufacturers.

I refer to the following examples:

• Breast implants and other plastic surgery implants for body enhancement
• Injectable implants for incontinence and bulking agents
• Stent implants for cardiac and vascular use
• Stents for esophageal placement
• Orthopedic and general implants
• Urology implants for erectile dysfunction and urology implants for incontinence
• Gynecology mesh for incontinence correction and hernia meshes
• Skin grafts and other grafts for cardiac use

There are very many more to list, but my point is this—the registration of all implants used patient stickers on each product registration patient form. One was kept by the hospital, one by the manufacturer/distributor and one by the overseas manufacturer, for marketing data collection. Patients’ names could be easily accessed at any stage of the product implant postoperative log. What concerns me is whether this slack process has improved or whether private patients’ records are still easily accessible.

Patient privacy is protected by statutory law, and any disclosure of this private vital information could be subjected to infringement in all countries that have similar laws of privacy.

This privacy issue did come up as an issue many years ago but was hurriedly dismissed by company importers as it fell into the too hard basket. Logging of patient implants’ information is mandatory, but, again, information left on desks is up for grabs.

Security of Patients’ Names

When I cite security issues, implant registration patient forms were kept in cars, laptop bags, and on work desks in offices. When the form hit the office, it would lie on a desk for days awaiting data impute and then filed in a folder under date for further reference against a patient warranty claim. So, ultimately, patient implant forms are easily accessible, calling for immediate review of the privacy of patients, unless this area has miraculously cleaned up overnight worldwide. I am told this process has not changed.

In speaking with several management representatives recently, orders placed for an implant to be scheduled for a procedure is accompanied with a patient Number rather than a patient name; this is a much more secure procedure.

Ideally, this process to prevent the patient’s identity being disclosed should be followed: patient names stay in the hospital with access allowed only by the implanting doctor. Companies should have no access to patients’ names whatsoever! A numbering or codes system would suffice. End of story. Patients have the right to privacy.

What Is the Upshot of All of This?

Ethical practices have improved, and companies outside the pharmaceutical business have or should adopt a code if their individual country lacks this legislation.

Even handing out chocolates at product shows is now frowned upon. Giving away company merchandise such as pens, lanyards, and other promotional paraphernalia is not accepted anymore, but the sponsorships of doctors traveling to a clinical meeting overseas is still being practiced worldwide, though under the banner of “education,” with travel costs being borne by the company. It seems that companies have restricted their promotional budget on the surface but have diverted these funds in a more and meaningful business manner. In the end, sales reps in the medical industry must look for other innovative ethical ways to sell and promote their products.

Ethics of Sales Representatives Working and Selling in a Clinical Environment

This is a most difficult and profound subject to talk about. Sales reps entering a clinical area such as the operating theater, angiography suite, day procedure, ICU, and any other clinical department should always be clear of sales influence. Having said that, I am as guilty as all others working in the theater.

Over the past 10 years, entry has tightened up, and entry is very restricted but still allowed. Companies get around this by employing qualified clinical specialists to enter these areas as they have the qualifications to do so. Certainly, this is partly true, but most hospitals worldwide permit only visiting medical officers and medical staff in these critical areas.

Reps selling, for example by assisting the doctor technically to implant a stent for example, is riding the bull of disaster today and has no place in our world of selling today.

The Future Possibilities

Be aware, the code of selling ethics in the medical industry may change in the future. As salespeople sell worldwide, draconian rules are likely to be introduced limiting sales calls to only 2 or 3 per year per doctor, this is now happening. Or perhaps sales calls may be allowed only on special occasions such as new product launches, or, worse still, sales calls may be banned altogether and only e-mail material allowed to be circulated. The point here is this: We, as salespeople, continue to twist the product performance truth, continue sponsoring doctors on overseas trips, and so on. This will push regulators to introduce stricter sanctions, thus cutting us out of the picture altogether. It will only take several serious complaints, and it is all over for us as professionals.

One can only imagine a future with no opportunities to deal with, as, for example, private hospital groups seeing only managers from the suppliers and putting us out of the picture to influence customers our way. This leaves us with public hospitals allowing hospital staff and doctors to see reps. This may be challenged soon as hospitals are now gathered into regional groups, with a central buying group supplying the entire area, a measure that would amount to restricting sales reps’ activity.

We as professionals, on the ground and inhouse, must realize if we are to survive as an entity, we have to be honest, tow the line and behave in the sales environment. We are at the cross roads of sales person survival and what we do and how we present our business is vital.

¹ Medicines Australia’s Code of Conduct, which was established in 1960, has been revised on a regular basis. Code of Conduct Edition 18.

² Code of ethics UK.

³ Jennifer LeClair, Monster. Health Care Division Bureau of Competition Federal Trade Commission Washington D.C. 20580