Medical Representatives in the Pharmaceutical and Medical Device Markets

 

March 31, 2024

BRACE Law Firm ©

 

To promote medicinal products and medical devices in the market, manufacturers and distributors use various marketing tools. At the same time, as market experts note, the attention of many pharmaceutical companies has recently shifted significantly from mass communication channels with broad target audiences directly to physicians and pharmaceutical specialists.[1] Such interaction is carried out, among others, by medical representatives (the "medical representative").

In this article, we consider the functions a medical representative performs, the requirements for their education and competencies, as well as the restrictions such a specialist must observe when interacting with medical and pharmaceutical workers.

Medical Representatives: Who Are They?

A regulatory definition for the term "medical representative" does not exist. However, the legislator mentions representatives of organizations engaged in the development, production, and (or) sale of medicinal products and medical devices within the context of restrictions imposed on medical workers and pharmaceutical workers. This conclusion can be drawn from Part 1, Article 67.1 of Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products (the "Law on Circulation of Medicinal Products", "Federal Law No. 61-FZ") and Article 74 of Federal Law No. 21-11-2011 No. 323-FZ, On the Fundamentals of Health Protection of Citizens in the Russian Federation (the "Law on Health Protection"). These restrictions are discussed in more detail below.

Based on the functions and tasks performed, a medical representative can be defined as a specialist representing a pharmaceutical company and/or pharmaceutical products in terms of increasing the professional level of healthcare specialists, fulfilling the pharmaceutical company's obligation to monitor the safety of pharmaceutical products, and promoting medicinal products, dietary supplements, medical consumables, and other related goods (the "products", the "pharmaceutical products").

Their main task is to find and attract clients, present information about the company's products, familiarize them with their advantages, and provide consultations on use. The target audience of a medical representative includes physicians and the administration of medical organizations, as well as pharmacy workers and heads of pharmacy organizations.

The Code of Good Practice of the Association of International Pharmaceutical Manufacturers (the "AIPM Code"), which is mandatory for members of this association, states that the purpose of the activities of medical representatives should be to increase the professional level of healthcare specialists and fulfill the obligation of the pharmaceutical company to monitor the safety of pharmaceutical products.

The functions of a medical representative depend on the specifics of the product being sold and the audience with which they collaborate. We distinguish the following main labor functions:

• visiting physicians and pharmacy organization workers for professional consultation on the properties, advantages of the promoted products, and specifics of use;
• conducting educational events on the use of products and updating the knowledge of medical and pharmaceutical workers;
• participating in pharmaceutical and medical exhibitions and conferences;
• conducting various marketing activities;
• analyzing the sales market and consumer demand for the drug, and collecting information on the activities of competitors;
• maintaining reporting documentation.

The functionality may expand or change depending on the tasks set and the locations of product promotion. In particular, a medical representative may promote products only in pharmacy organizations, only among the medical community, or in both sectors. Furthermore, changes occurring in the pharmaceutical industry itself and in healthcare also introduce adjustments.

For example, as experts point out, the classical model of promotion in pharmacies is no longer effective enough in most cases. One of the reasons for this is the centralization of pharmacies, where "decision-making points shift from pharmacy managers to higher levels: assortment formation, shelf space distribution, decisions on changing inventory levels, and so on — in most cases, all of this is already managed by pharmacy chain offices, making managers mere administrators. All of this significantly reduces the scope of opportunities for a medical representative to work at the point of sale".[2]

As for medical representatives working with the physician community, a trend of reduction or refusal of "face-to-face" visits by medical workers has been observed in recent years. This was noted by two-thirds of physicians surveyed by the research company Top of Mind MR&C. "According to the majority of respondents, the main factor affecting the reduction in the duration of medical representative visits is the increase in the workload on physicians, especially for pediatricians and general practitioners".[3] Additionally, the duration of meetings is significantly affected by physicians' access to information sources through other communication channels, the increasing number of medical representatives, or their low professional level. All these factors lead to "face-to-face" visits being increasingly supplemented by remote communication (communication via Skype, messengers, etc.).

Requirements for the Education and Competencies of a Medical Representative

Despite the long-term existence of such specialists in the labor market, qualification requirements and professional standards establishing requirements for the education and labor functions of a medical representative have not been adopted to date. Although the National Pharmaceutical Chamber began developing professional standards back in 2017,[4] the work was never completed due to the diverse nature of such specialists' tasks.

The AIPM Code establishes that medical representatives of pharmaceutical companies must have sufficient training and possess the necessary knowledge to provide healthcare specialists with full, objective, reliable, and up-to-date information about pharmaceutical products (Clause 3.6.4 of the AIPM Code).

As we can see, these requirements are quite "vague" and do not provide an answer regarding the level of education and qualification of these specialists.

In the absence of specific requirements, employers independently establish requirements for the education level and qualifications of a medical representative. Most large pharmaceutical organizations require a higher medical or pharmaceutical education, and less frequently, a secondary specialized education. This is because it is difficult to train a specialist with a non-core education so that they can communicate freely with physicians and pharmaceutical workers without deep knowledge in the fields of medicine and pharmacy. Some employers, conversely, believe it is easier to train an experienced "salesperson" in the intricacies of medicine than a physician in marketing.

In the 1990s and early 2000s, employers often required an advanced degree for employment as a medical representative. As pharmaceutical market experts note, during that period "there was a huge financial gap between the salary of a novice medical representative and, for example, a medical university lecturer or a talented clinician. Today, the profession of a medical representative is no longer as prestigious in the eyes of holders of medical and pharmaceutical diplomas. Moreover, there is a clear trend of returning to the original profession".[5]

All these factors undoubtedly influence the labor market and employer requirements for candidates.

In addition to professional knowledge, a medical representative needs to know the specifics of the pharmaceutical market, pricing, the basics of marketing and management, and possess computer literacy. Employers often require a personal car and driving experience.

Personal qualities such as communication skills, organization, flexibility, and stress resistance are also important for a medical representative. A lack of such skills and qualities often leads to professional burnout and dissatisfaction with the profession. According to a study conducted by experts from the Russian division of the company "Popsicube Fovea"[6] among medical representatives, the share of those dissatisfied with their profession and wishing to change it is much larger than among other categories of pharmaceutical company personnel. For instance, over 27% of medical representatives stated during the survey that they do not like their work — only financial interest keeps them in the profession. Only 16% of respondents would stay in their current profession.

The absence of professional standards for medical representatives is a negative factor for both employers and specialists, as a professional standard can be used to create a job description, assess a specialist's professional qualification, and develop a training program for medical representatives.

Where Do Medical Representatives Work?

The main employers of medical representatives are manufacturers and wholesale suppliers of medicinal products. In some cases, medical representatives may work in scientific research organizations.

In addition to hiring under a labor contract, medical representatives can be engaged through outsourcing. For this purpose, a service agreement is concluded with a marketing agency. It must define a detailed list and terms of the services provided. Furthermore, it is recommended to regulate the procedure for providing services (the number of medical representatives involved, requirements for their education and qualification level, number of visits, and other conducted events), as well as the procedure for reporting.

It is also not prohibited to engage a medical representative with self-employed status. This allows for savings on taxes, social payments, and workplace organization. However, in this case, the pharmaceutical company or marketing agency bears the full burden of setting tasks and monitoring work.

The choice of method largely depends on the tasks facing the pharmaceutical company and the availability of qualified personnel to perform them. The advantages of hiring specialists through a marketing agency are reduced efforts in searching for, training, and managing personnel, a possible reduction in maintenance costs, and the possibility of a quick start in performing tasks. However, even with this method, the pharmaceutical company must exercise control over the volume and quality of work performed.

Quality Control and Incentivization of Medical Representatives

To monitor the qualitative and quantitative indicators of the work of medical representatives, pharmaceutical companies apply various methods. Among the most common are:

• monitoring movement using GPS devices;
• reporting on visits, including the use of CRM systems and photo reports;
• calling clients;
• double, triple, and "follow-up" visits.

However, to hold an employee accountable, establishing the fact of improper performance of duties is not enough. For this, several measures must be carried out:

1. Detail the duties in the labor contract or job description.

For example, it is advisable to determine the number of daily visits, the procedure and terms for providing reporting, and other circumstances significant to the employer.

2. Establish the procedure and methods of control through local acts and familiarize the employee under their personal signature.

Fix the fact of improper performance of duties.

The Labor Code of the Russian Federation does not regulate methods of documentation. For this, the employer can use any method that does not contradict the law, as long as it sufficiently clearly records the violation.

Another way to control and increase efficiency is the establishment of KPI (the "Key Performance Indicators"). In essence, these are indicators of a medical representative's work by which their work is evaluated and paid, and bonuses are calculated. These may include: the dynamics of sales growth, the quantitative and qualitative completion of visits, brand awareness among surveyed respondents, the share of presence on pharmacy shelves, etc. Approaches to forming KPIs are considered in detail in Pavel Feldman's book, KPIs for Evaluating the Work of a Medical Representative.

When choosing KPIs, the following factors must be considered: they must be aimed at achieving the company's business goals, and there must be an ability to track their completion and evaluate them.

Restrictions on the Interaction of Medical Representatives with Medical and Pharmaceutical Workers

To prevent unfair behavior that could harm a patient or provide an unreasonable priority to a particular product, legislation establishes restrictions on the interaction between representatives of manufacturers and distributors of medicinal products and medical workers. Thus, in accordance with Part 1, Article 67.1 of the Law on Circulation of Medicinal Products, organizations engaged in the development, production, and (or) sale of medicinal products for medical use, organizations holding the rights to use the trade name of a medicinal product, wholesale organizations, and pharmacy organizations (their representatives, other individuals, and legal entities carrying out their activities on behalf of these organizations) are not entitled, in relation to medical workers and heads of medical organizations, to:

• present gifts or pay monetary funds (except for remuneration under contracts during clinical trials, remuneration related to the medical worker's pedagogical and (or) scientific activities), including paying for entertainment, recreation, or travel to a place of rest, as well as involving them in entertainment events conducted at their own expense;
• conclude agreements on the prescription or recommendation of medicinal products for medical use to patients (except for contracts for clinical trials of medicinal products);
• provide samples of medicinal products for medical use for the purpose of presenting them to patients (except for cases related to clinical trials of medicinal products);
• provide false and (or) incomplete information about medicinal products for medical use;
• encourage the prescribing of medicinal products for medical use on forms containing advertising information, or on prescription forms on which the name of a medicinal product for medical use is pre-printed;
• visit them during working hours at their workplaces, except for cases related to clinical trials of medicinal products, participation in meetings of medical workers, and other events aimed at increasing their professional level or providing information related to monitoring the safety of medicinal products.

Note that by virtue of Part 1, Article 74 of the Law on Health Protection, the procedure for participating in these meetings is established by the administration of the medical organization and is usually posted on its official website. We recommend that medical representatives familiarize themselves with this procedure in advance.

Furthermore, according to Article 67.2 of the Law on Circulation of Medicinal Products, when conducting scientific events or other events aimed at increasing the professional level of medical workers or providing information related to monitoring the safety of medicinal products, organized by the aforementioned organizations, their representatives, and (or) financed by these organizations and their representatives, it is prohibited to prevent the participation of other organizations that produce or sell medicinal products with a similar mechanism of pharmacological action, or to create discriminatory conditions for some participants compared to others, namely:

• providing different amounts of time for participants' speeches, or different sizes of area for demonstrating samples of medicinal products or promotional materials at exhibitions and stands, except where such conditions are fixed in agreements on financing these events and are due to different costs of the participants in organizing them;
• establishing a contribution amount for event participants that exceeds the costs of organizing them and leads to an unreasonable restriction on the number of participants.

Also, Part 2 of this provision obliges the disclosure of information about conducted events on the official website of the pharmaceutical company and to Roszdravnadzor. Within two months before the start of these events, they are obliged to provide access to information about:

• the date, place, and time of the events;
• plans and programs for the events;
• topics planned for consideration;
• the composition of their participants.

Similar information is sent to Roszdravnadzor using the electronic service "List of Notices on the Conduct of Scientific Events" on the Roszdravnadzor portal. To obtain personalized access to the electronic service, it is necessary to provide information on the appointment of persons responsible for entering data via e-mail and in paper form with the organization's seal to the address: 109074, Moscow, Slavyanskaya Square, 4, bldg. 1.

The AIPM Code also regulates specifics of interaction with healthcare specialists. Let us consider them in detail:

• cooperation between pharmaceutical companies and healthcare specialists must not result in a conflict of interest for healthcare specialists, in particular between their professional duties and personal interest (Clause 3.1.2);
• it is not permitted to offer, promise, provide, or transfer remuneration in any form to healthcare specialists for the prescription or recommendation of a certain pharmaceutical product to patients, or to conclude agreements with them on the prescription or recommendation of any pharmaceutical product to patients (Clause 3.1.3);
• pharmaceutical companies are prohibited from providing or offering healthcare specialists any items that promote pharmaceutical products, other than promotional materials (Clause 3.5.2.);
• medical representatives are entitled to participate in meetings and other events for healthcare specialists in medical organizations in the manner established by the given medical organization.

Within these events, medical representatives are entitled to provide healthcare specialists with promotional printed materials and information materials of "insignificant value", provided that they increase the professional level of healthcare specialists.

The provision of this information on CDs and memory cards not intended for personal use is permitted. At the same time, any materials, including promotional ones, must increase the professional level of healthcare specialists and not pursue exclusively advertising goals (Clauses 3.6.2–3.6.3.).

Similar restrictions are established for the interaction of pharmaceutical companies and medical representatives with pharmaceutical workers. In accordance with Part 2, Article 67.2 of the Law on Circulation of Medicinal Products, pharmaceutical organizations and their representatives are not entitled, in relation to pharmaceutical workers and heads of pharmacy organizations, to:

• present gifts or pay monetary funds, including paying for entertainment, recreation, or travel to a place of rest, and involving them in entertainment events conducted at their own expense;
• provide samples of medicinal products for medical use for presentation to the public;
• conclude agreements on offering certain medicinal products for medical use to the public;
• provide false and (or) incomplete information about medicinal products for medical use, including those having the same international nonproprietary name.

Specifics of medical representatives' interaction with pharmacy workers in the AIPM Code are regulated in Section 6.5 and contain the following provisions:

1. Representatives of pharmaceutical companies are entitled to visit pharmacy organizations for the purpose of informing pharmaceutical workers and heads of pharmacy organizations about manufactured or sold pharmaceutical products.

2. Pharmaceutical companies are entitled to conclude service agreements with pharmacy organizations, including those for:

• the display of over-the-counter (OTC) pharmaceutical products ordered by the pharmaceutical company;
• the placement of promotional materials in the pharmacy organization and on its website regarding over-the-counter pharmaceutical products, as well as information materials dedicated to the prevention and treatment of various diseases;
• the conduct of joint promotions for over-the-counter pharmaceutical products, including customer surveys;
• the presentation of incentive gifts to customers upon the purchase of a certain product, which may contain the logo of the company or the company's over-the-counter pharmaceutical product.

3. Pharmaceutical companies are not entitled to organize programs according to which they provide property prizes to pharmaceutical workers, heads of pharmacy organizations, and pharmacy organizations for achieving certain sales results.

As we can see, the restrictions established in the AIPM Code are broader and more detailed than in the Law on Circulation of Medicinal Products. Furthermore, although some norms are addressed to pharmaceutical companies, we believe it is necessary to organize work for their compliance by medical representatives as well, who are effectively the company's representatives in medical and pharmacy organizations.

Liability of Medical Representatives for Violation of Legislation

For violations in the course of their activities, a medical representative may be held to disciplinary, administrative, or criminal liability.

Disciplinary liability is imposed for the non-performance or improper performance by a medical representative, through their fault, of the labor duties assigned to them. In accordance with Article 192 of the Labor Code of the Russian Federation, the following disciplinary sanctions may be applied for these violations:

• remark;
• reprimand;
• dismissal on grounds provided for by the Labor Code of the Russian Federation.

For violations of the rules of interaction between medical and pharmaceutical workers and pharmaceutical companies, administrative liability is provided:

• Under Article 6.29 of the CAO RF, Failure to Comply with Duties on Submitting Information about a Conflict of Interest when Exercising Medical Activity and Pharmaceutical Activity. However, in accordance with the subjective scope of this provision, medical and pharmaceutical workers of pharmacy institutions, rather than medical representatives, are held liable.
• Under Article 19.7.8 of the CAO RF, Failure to Submit Information or Submission of Knowingly False Information to the Federal Executive Body Exercising Functions for Control and Supervision in the Field of Healthcare. Under this provision, a pharmaceutical organization or its official may be held liable. The fine for officials is from 10,000 to 15,000 rubles; for legal entities—from 30,000 to 70,000 rubles.

However, we were unable to find practice regarding the imposition of liability for the non-performance of these duties.

The most important aspect is the need to prevent a corruption component in the activities of a medical representative, as these actions carry the risk of criminal liability. Thus, in 2014, the Investigative Committee of the Russian Federation initiated a criminal case against a medical representative of a pharmaceutical company for committing a crime provided for by Part 5, Article 291 of the Criminal Code of the Russian Federation, Giving a Bribe to an Official Committed on an Especially Large Scale. According to investigators, the pharmaceutical company employee gave bribes totaling more than 1,000,000 rubles to physicians of medical institutions for prescribing drugs manufactured by a specific pharmaceutical company to patients.[7]

In another case, a medical representative of a company paid for a regional Ministry of Health representative's trip to a conference as a bribe for performing actions within their official powers. Subsequently, the criminal prosecution against the medical representative was terminated due to active repentance. Regarding the pharmaceutical company, the prosecutor initiated an administrative case under Part 1, Article 19.28 of the CAO RF, Illegal Remuneration on Behalf of a Legal Entity. The company was able to achieve the termination of the administrative case in court, proving that it took all measures depending on it to prevent this offense:

• it developed a code of ethics and official conduct for employees and familiarized the medical representative with it under signature;
• it included provisions in the medical representative's labor contract and job description obliging the employee to comply with anti-corruption rules;
• it conducted regular training for employees on knowledge of the requirements of anti-corruption legislation.[8]

In conclusion, we note that the profession of a medical representative remains in demand in the pharmaceutical market. They play an important role in providing medical and pharmaceutical workers with information on pharmaceutical products, thereby contributing to the improvement of the quality of medical care. At the same time, it is worth noting that the activity of a medical representative is insufficiently regulated, which negatively affects the assessment of the quality of this specialist's work.

_____________

References

1. Marketers spoke about opportunities to increase the efficiency of the work of medical representatives. July 19, 2023. // Website of the electronic edition "Pharmaceutical Bulletin".
2. Pavel Lisovskiy. What future awaits pharmacy medical representatives? // Pavel Lisovskiy's website.
3. Natalya Maskina. The increase in the workload on physicians affects the reduction of the time of visits of medical representatives. July 3, 2019 // Website of the electronic edition "Pharmaceutical Bulletin".
4. Natalya Maskina. The National Pharmaceutical Chamber has begun developing a professional standard for the medical representative specialty. February 8, 2017 // Website of the electronic edition "Pharmaceutical Bulletin".
5. Ekaterina Altayskaya. Medical representative: an obsolete profession? // Medicinal Supply. No. 5, 2017.
6. Natalya Maskina. About a third of medical representatives do not like their work. February 6, 2020 // Website of the electronic edition "Pharmaceutical Bulletin".
7. STADA: Our employee did not receive any instructions contradicting the current legislation. May 30, 2014 // Website of the electronic edition "Pharmaceutical Bulletin".
8. Decision of the Syktyvkar City Court of the Republic of Komi dated October 14, 2014, in case No. 12-1248/14.

March 31, 2024.