Pharmaceutical sector meets around the Anti-Corruption Law

Attention and urgency in the implementation of Compliance programs. These were the main points addressed by participants at a seminar held in November by the Pharmaceutical Products Industry Union (Sindusfarma) in partnership with ETCO, on Law 12.846.

In his opening lecture, the former CEO of international laboratories, Jorge Raimundo, recalled that two years ago the code of ethics for pharmaceutical companies was completed and that signing the document is a prerequisite for any company in the sector. “Companies that want to have a history of more than 100 years cannot go wrong on a daily basis. In the pharmaceutical industry, it is essential to respect ethical principles and companies have to follow codes of conduct that protect investors from illegal acts that could compromise their market value, ”he added.

ETCO's Executive President, Evandro Guimarães, highlighted the institute's objective of raising awareness and mobilizing society so that the new measure can reduce corruption among public officials. The Executive President of Sindusfarma, Nelson Mussolini, cited the allegations of corruption raised by Operation Lava Jato to illustrate the importance of a change in the attitude of companies when it comes to corruption. “When you see everything that happens in Brazil today, you understand the importance of beginning to live ethics within the country”.

During the seminar, CVS Caremark's Compliance Officer, Alexandre Serpa, pointed out that the high figures involving pharmaceutical companies and the already known modus operandi the sector puts it in the sights of the Anti-Corruption Law. He pointed out that these factors further intensify the need for companies in the industry to develop serious compliance programs that, according to the law, can serve as mitigants in cases of conviction. In addition, he added that the risks for the segment have changed in recent years, requiring a review of existing prevention actions. “Ten years ago, corruption was paying for travel and gifts for doctors. Today, it involves high-cost drugs and relationships with medical associations and the government ”.

The person in charge of Machado, Meyer, Sendacz and Opice Advogados in the Compliance area, Leonardo Machado, emphasized the importance that the segment should give to the theme. “The pharmaceutical industry has peculiar characteristics in contact with the public sector and must be aware of the impacts inherent to the new legal text. Experiences in the application of similar anti-corruption laws in other countries, make it clear that the sector is one of the ones that most draws the attention of the authorities, ”he said.

Also present at the event, the Security and Control Analyst at the Federal Comptroller General (CGU), Flávio Rezende Dematté, said that Law 12.846 came to correct a gap Brazil in relation to the liability of the Legal Entity for acts of corruption. The measure also stands out, according to him, for its focus on the economic bias of corruption by imposing high fines and the publication of the condemnation of businesses involved in illegal acts.

Brazil to track 5 billion boxes of medicines by 2016

drug trackingThe Brazilian pharmaceutical industry is preparing to implement one of the largest drug traceability programs in the world, created in 2005 with the help of ETCO. With a final implementation deadline defined by the National Health Surveillance Agency (Anvisa) for 2016, this program should track 5 billion boxes of medicines across the country, according to Sindusfarma, the union that represents the sector.

Established by Law 11.903 / 09, the program determines that each package of medicine receives the printing of a two-dimensional (2D) code, whose technology has already been chosen by the agency (GS1 Data Matrix). This seal, known as the Unique Medicines Identifier (IUM), will store data on the route of each bottle, from the factory to pharmacies (estimated between 60 and 90 in Brazil), in addition to hospitals. The IUM will also store lot numbers, series and expiration date.

For the consumer, the greatest benefit of the new system is the security it adds to medicines. “The industry will be able to know exactly where its product is and act more quickly and in advance in case of problems”, explains the executive president of Sindusfarma, Nelson Mussolini. He adds that traceability can also further reduce drug theft, which has already been greatly minimized by the Electronic Invoice and Tax Substitution, which practically extinguished the figure of the recipient.

Currently, drug logistics information is fragmented across the various agents in the pharmaceutical chain. The industry controls the process from the factory to the distributor. Thereafter, batches of different groups of drugs are fractioned and grouped into smaller shipments, which make up five or six logistical steps to the final destination.

With the new system, the data will be centralized in a database whose administration is the responsibility of the drug registration holder. Anvisa determined that each link in the chain feeds this bank with the information it knows. The bank may be freely consulted by the agency for monitoring and inspection purposes.

Anvisa also defined that by December 2015 all laboratories have at least three lines incorporated into the system. Pharmaceutical Libbs announced in September that it had adapted to that determination. "It is a system that brings benefits to the consumer, from the point of view of security, and for the sector, helping to combat fraud, smuggling and counterfeiting," said the Minister of Health, Arthur Chioro.

Until December 2016, each bottle of medicine that leaves the factories must be traceable. But there are still issues to resolve regarding the confidentiality of the information.

Since the regulation states that data must be provided to the industry, which is also responsible for the costs of the system, it is likely that retail and wholesale will question this requirement, arguing that it violates competition laws. The industry, on the other hand, claims that full access could anticipate and minimize problems. “If the system tells us that there are complaints about drugs that have no effect, for example, I will go there and investigate. Until we are notified to make a recall, the problem may become bigger ”, says Mussolini.

The executive president of Sindusfarma says that the issue of confidentiality can effectively delay the implementation of the system and is working with entities involved to find a solution. “There is probably a technological path that resolves, instituting access controls in the system. But if that is the solution, we will have to adjust the current regulations. ”

(With advice from Libbs Farmacêutica and the Brazilian Automation Association)