Pharmaceutical industries and how to combat and closely observe their frauds!
Fabio Albert
Diretor Executivo e Opera??es | Gest?o de Risco, Detalhista, Desenvolvimento de Novos Negócios
When you search for this subject on the internet, you have most likely encountered or will face constant attacks on the pharmaceutical industries around the planet, they are dozens of scandals involving laboratories, doctors, entities and many professionals related to the branches of pharmacy and chemistry .
There are thousands of dollars in the light of ethical questioning, we understand here, unfortunately the world is full of fraudsters in all branches of activity, could not be different in the pharmaceutical industry.
To do so, we can reach the extreme, where some lines of reasoning induce a significant amount of the population to think that the medicine industry itself is already a "farce", and that no, well, no, synthetic product for health would be worthy of production and marketing.
Believe these lines of thought that all we need to treat diseases can be taken from nature, not least worrying, there are those who insist on disclosing that the drug industry creates the disease, then sell the cure or comfort for pain and other symptoms.
There will be no judgment in this article, nor at least, it will be possible to extinguish the subject fraud in drugs, but as professional fraud specialists, we have to repudiate and work hard so that any kind of illegal or unethical act is investigated, divulged and treated as a crime, or against humanity, regulators, governments or any other injured party.
The private drug industry is a for-profit organization, it functions as normally all types of industries work, so it is subject to the same types of fraud, so we can think of the concept of "Fraud Star", which through five typologies it is demonstrated, where, organizations must take the greatest precautions to avoid financial losses and losses of assets.
1 - Fraud in the purchasing department
Every operational flow circulates through purchases, whether for productivity, services, maintenance in general or simple expenses.
- Financial volume traded is high
- Critical factor of success in the organization
Eg purchase order elaborated with scheme of "coverage" collusion with suppliers.
2 - Fraud in internal and external sales
- Tax Notes = Average NF / Sales with Shipping / Cold Note.
- Indirect Sales = Representatives / Advertisers / Consultants (Orders and Expenses)
- Closing and Cancellation of orders
Eg: Diversion of funds for field expenses and educational sponsorship
3 - Accounting Fraud
Accounting routines: closings, tax releases, property, plant and equipment controls, tax calculations and reconciliation.
Vulnerabilities = Manual processes, lack of segregation.
Eg: Banco Panamericano = Rombo 4,3bi, "makeup" balance with nonexistent credit portfolios.
4 - Fraud in Information Systems
- Social Engineering = persuasion, take advantage of ingenuity. Kevin Mitnick argues, "computer fraud is a mix between technical knowledge and social engineering"
- Real knowledge of systems and manipulation conditions (k-user of integrated systems)
Eg: Mitnick and Pacific Bell / Inclusion of a false partner in the system of requests and requisitions.
5 - Fraud in services taken and / or maintained
The services to maintain an organization never end, they are fundamental, that is, they need to be conserved and renewed constantly, others can be occasional or necessary only in some specific moments.
Examples:
- Maintenance: Schedule HH (Man Hour) = Lack of control in the appointment and non-segregation of activities.
- Maintenance: Urgent and emergency = Direct contracting, execution without OS.
- Painting: Hiring services for three hands of paint = applies only two, fraud of one-third of the contracted value.
- Petrobrás = nonexistent services and fraudulent contracts.
Healthcare professionals and the pharmaceutical industry
Although there are many misgivings about the involvement of the pharmaceutical industry in fraud to boost revenues, they are also the target of numerous types of fraudulent acts perpetrated by their collaborators, such as propagandists and representatives with health professional classes, for example:
Propagandists presenting health professionals with items out of legislation to leverage their own awards.
Representatives sending orders for unsolicited products to increase sales percentage and receive higher commissions.
Elaboration of events outside the company specification to impress health professionals and raise the possibility of greater demand in the market.
Free sample shifts for exchange with colleagues from other laboratories or irregular sale to meet personal desires.
All are harmful acts, and by nature itself cause damage to some part, especially when there is direct participation of the industry, see the example that recently shook Brazil, more than R $ 9.5 million diverted from the SUS to attend people who in serious disease, so there were several requests for judicial authorization to import specific medicines.
Particularly I have followed many similar cases, and also cases that in addition to exposing the manufacturers, put them at risk due to the rules imposed by ANVISA, there are currently rules of distribution of gifts, rules for events, rules for marketing among others, so the Compliance plays an important role within the pharmaceutical industry.
Forgery of medicines
There have also been falsifications of pharmaceutical products, we can call such situations of fraud by adulteration, in this area, possibly falsification of drugs is verified as follows:
Poisonous Remedy
Products without active principle.
With active principle different from that declared on the label.
False active principles.
Divergences in quantities of inputs and / or active principles.
Products produced correctly, but distributed in a way.
In Brazil, studies show that about 19% of the circulating drugs can be falsified, it is understood in this situation, that not all types of products are falsified. The fraudulent acts regarding medicines are directed to items of high added value or then of great search by the population, among them we have examples of hormones in general, drugs against cancer, and practically the chief car, that are those products against the sexual impotence, that has good added value with constant search of the population.
Some measures were taken by the government to avoid the growing circulation numbers of counterfeit products, were measures drawn from a major debate between regulatory agencies, the pharmaceutical industry and society in general. Are they:
A. Regulation of the safety criteria for packaging of medicinal products.
B. Ordinance regulating Good Manufacturing Practices for the Pharmaceutical Industry.
C. Ordinance creating the National Registry of Medicines, Laboratories and Companies.
Agreement with the Ministry of Finance to combat tax evasion and fraud in invoices.
D. Ordinance that regulates the disposal of pharmaceutical production, including packaging and machinery.
E. Creation of the National System of Notification of Adverse Reactions.
Implementation of a new working method to expedite the demands of the National Health Surveillance Secretariat.
F. Revitalization of the National Inspection Program in the Pharmaceutical and Pharmochemical Industry (PNIFF).
However, the best measure that is on the agenda and some laboratories are already with advanced work is the Traceability of medicines, in it the entire chain can know where the drug came from, where it happened and where it will arrive, briefly is the total follow-up since production to consumer, ie direct impact across the pharmaceutical chain, such as manufacturers, distributors, hospitals, large retail chains and even small pharmacies, discussions on deadlines, phases and adequacy are still on the agenda, including in relation to the heavy investments in technology and adaptation, but if we do want fraud to stop, it is important to put pressure on the responsible bodies to increase commitment and to charge the whole chain for adjustments to be made as soon as possible.