Tag: Pharmaceutical products

Project excludes from the Penal Code the crime of selling counterfeit medicine.

(04/11 - Chamber of Deputies)

The Chamber of Deputies analyzes Bill 8028/14, by Deputy Cleber Verde (PRB-MA), which excludes from the Penal Code (Decree-law 2.848/40) the crime of importing, selling, keeping in storage, distributing or delivering medicinal or therapeutic products of unknown origin. Currently, the penalty provided for the crime is imprisonment for 10 to 15 years and a fine.

Cleber Verde explains that the penalty previously provided for the crime was from one to three years, and that the Code was amended by the so-called Remedies Law (Law 9.695 / 98), which included this practice in the list of heinous crimes. He recalls that the change was motivated by the massive discovery of fake drugs, manufactured and marketed in the country.

 

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Counterfeit medicines

Senator Jorge Viana (PT / AC) presented a favorable opinion to the Chamber of Deputies Amendment to the Senate Bill (ECD) 464/11, which provides for the prohibition of establishments involved in counterfeiting of medicines and cosmetics. The opinion was presented last Friday (6/12), at the Constitution, Justice and Citizenship Commission (CCJ) of the Federal Senate.

According to the rapporteur, the proposal under analysis aims only to expand the list of products that, when falsified, generate the non-application of a period of prohibition of establishment provided for by law. Such measure goes against the public interest and actions taken to curb piracy and adulteration of products. The senator believes that the counterfeiting of personal hygiene and perfumery items continues to grow in our country, and in view of this reality it is necessary to create mechanisms to end impunity for violators.

PLS 464/11, from sen. Humberto Costa (PT / PE), changes the federal health legislation to provide that the period of up to 90 days of interdiction of establishment, as a precautionary measure, will not apply in the event of verification of falsification of medicines, drugs, pharmaceutical supplies, related, fraudulent, counterfeit or adulterated cosmetics and sanitizers of public health interest.

The text also provides that, as long as the establishment's interdiction continues, the use of the facilities in which it operated will be prohibited by another establishment that develops a similar activity, even if only partially.

The proposal awaits inclusion in the CCJ's agenda for deliberation.

Source: Agência Senado and ETCO

Anvisa determines seizure and destruction of batch of fake medicine

The National Health Surveillance Agency (Anvisa) ordered the suspension of the manufacture, distribution, dissemination and commercialization of the drug Reumatex, manufactured by an unknown company. The agency also determined the seizure and destruction of the remaining products on the market. The resolution was published last Thursday (03/09) in the Federal Official Gazette.

The drug was being manufactured and marketed irregularly, as it has no registration. The product had in its packaging the National Register of Legal Entities of a company that does not know Reumatex and the registration with the Ministry of Health of another remedy.

Due to the presence of a foreign body in an ampoule of the drug Contracep, an injectable contraceptive, Anvisa also determined the suspension of the distribution and sale of lot 601530.1. The medicine is manufactured by the company Germed Farmacêutica Ltda and the batch is valid until 01/16. The company will have to collect the existing units on the market for the affected lot.

Source: Valor Online

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The hateful trade in fake medicines

It is notorious to sell fake, counterfeit and pirated products worldwide. Formal industry and commerce, which paid high taxes (especially in Brazil), are hampered by unfair competition from opportunists who, outside the law and in total disrespect to the consumer, obtain great advantages, harming the whole society. The important thing for these criminals is to make money - a lot, no matter how.

And when it comes to earning a lot, it is a lot: it is estimated that this illegal market moves around R $ 13 billion a year in Brazil - taking into account only medicines. The most expensive remedies (fighting cancer, for example) and the most sought after (treatment of erectile dysfunction, weight loss, anabolic steroids) are those that suffer most from counterfeiting. And, in fact, the high taxation (on average 34%) on medicines reinforces the immense profitability of crime merchants.

When it comes to medicines, this perverse marketing gains an aggravating factor. In addition to economic and tax issues, we have the damage of what is most important: health. An example of this brutality was harshly presented at the Piracy CPI, in 2013, at the Chamber of Deputies. In one of the statements, a criminal exposed, with great coldness, a terrifying logic. Asked why he forged cancer-fighting drugs, he replied: "They are the ones that make the most profit."

It is important to note that the consumer has an essential role in combating this illegality and immorality. Understanding all stages of the legal process is part of raising awareness. First, it has a very high investment in research, tests and improvements carried out for years; sometimes unsuccessfully, representing the loss of all investment to approve a molecule.

After this stage, another process begins: that of validation by the health and health surveillance agencies, which also consume time, human and financial resources and the registration of trademarks and patents. Once approved, we have the manufacturing, marketing and distribution in complex logistics and, of course, the payment of taxes, licensing fees and social contributions resulting from formal employment relationships. Finally, it is worth remembering that companies engaged in research, manufacturing, marketing and distribution are registered and known, and can be easily found and, if necessary, brought to administrative and judicial levels.

On your side, the criminal. Without any investment, those who have proven acceptance by the market will falsify the medicine. Withholding taxes, no formal employees, taking advantage of underemployment and even slave labor, in addition to using the most precarious facilities, without any concern with hygiene and cleanliness. In short: very little investment, very low risk and high profits. The consumer buys a mock medicine and receives the worsening of the disease, sometimes death. They have already been found in counterfeit arsenic, cement powder, floor wax, paint, talcum powder, nickel, among others.

This alarming situation deserves full attention on the part of society and, of course, the government, at all levels. The integrated action of the public administration bodies, the strengthening of the inspection areas, especially the National Health Surveillance Agency (Anvisa), the constant improvement of pharmacovigilance, which may point to the use of false medicines, the procedures for traceability of medicines, the improvement of the drug purchase process and consumer awareness work are initiatives that must be contemplated, with the objective of reducing criminal action.

The National Forum Against Piracy and Illegality (FNCP), a non-profit civil association, has business associations and companies as members and has been assuming an important role in this process, by supporting inspection actions (Thematic Operations to Combat Crimes against the Tax Authorities and Public Health, organized by the Federal Highway Police on federal roads in conjunction with the Federal Revenue Service, the Federal Police and Anvisa) and awareness raising (Seminar - annual - of the Triple Border, in Foz do Iguaçu, in addition to guides for consumers and government).

These initiatives demonstrate that much remains to be done. The breach of public coffers is impressive, and the damage to health is immeasurable. Public authorities, civil society and companies must persevere in this just and indispensable struggle. Health thanks you.

Edson Luiz Vismona

President of the National Forum Against Piracy and Illegality (FNCP) and the Instituto Brasil Legal, he was Secretary of Justice and Defense of Citizenship of the State of São Paulo

Source: Mail Braziliense

Pharmacy owners are convicted of federal program fraud

Justice condemned the owners of a pharmacy in Marília (SP) for defrauding a federal program that subsidizes medicines sold to the population at lower prices. Losses to public coffers amount to R $ 38,4 thousand.

An inspection carried out by the SUS National Audit System to verify the program's execution in the last months of 2009 found that sales were being made in disagreement with the rules. Among the irregularities are falsification of signatures and commercialization of medicines without a prescription.

The owners of the pharmacy were sentenced to two years in prison, but the sentence was converted into service to the community, in addition to a fine of ten minimum wages, in the amount in effect at the time of the facts. They will also have to return the wrongly received money to the federal government.

How it works

The federal program establishes the sale of cheaper drugs to the population in private pharmacies. Consumers pay only a portion of the price and the rest is paid by the government in transfers to partner establishments, according to the prices in a single table.

In order to receive the amounts, merchants must follow a series of requirements, including the collection of signature and personal data from customers in tax coupons and the maintenance of correct information about the drugstore in the Ministry of Health's register.

Source: G1

 

 

Bill expands drug fraud ban

Approved with changes in the Chamber of Deputies, the bill returns to the Senate (PLS 464 / 2011) by Senator Humberto Costa (PT-PE), which allows the suspension of activities, for as long as necessary, of a business establishment involved in the falsification, adulteration or alteration of medicines.

Currently, the maximum interdiction term as a precautionary measure, provided for in the law dealing with sanitary infractions (Law 6.437 / 77) cannot, in any case, exceed 90 days. After that period, the establishment is released automatically. According to the project, the interdiction of establishments that falsify or adulterate medicines and cosmetics may exceed the 90 days of the current rule to make it possible, for example, to carry out tests, tests and analyzes.

Approved by the Senate's Constitution, Justice and Citizenship Commission (CCJ) in a terminative character, the project was forwarded to the Chamber, where it passed as 3673 PL / 2012. By means of amendments, the Chamber's Social Security and Family Commission included laboratories for personal hygiene and perfumery products among those that could be banned indefinitely. The amendment will be examined by the CCJ, where it awaits the appointment of the rapporteur.

 Source: The Senate Agency

With ETCO's participation, Amcham discusses drug piracy

For Roberto Abdenur, the problem has universal proportions and is a risk to public health

On September 10, the Brazil-United States Chamber of Commerce (Amcham) held an important meeting to discuss drug piracy in Brazil. ETCO's Executive President, Roberto Abdenur, was one of the moderators of the event, which showed that the fight against the trade in counterfeit or adulterated medicines has to be strengthened with the integrated performance of the authorities, the use of technology and awareness of the population.

ETCO is part of Amcham's anti-drug piracy group, which shows the long-standing partnership between the two entities.

“Health piracy is a problem of universal proportions. ETCO operates in sectors where there is a risk of destabilizing the economic balance, but this is a social problem, which concerns public health ”, said Abdenur.

The medication tracking project, which will help combat cargo theft and will allow identifying who manufactured the product, who sold it, who dispatched it and when it arrived at the distributor and pharmacies, is an initiative supported by ETCO. The National Medicines Control System, determined by Law 11.903 / 09, passed a public hearing in May.

Entities in the medications sector should be invited to new talks to align proposals. The ideas will be analyzed with the perspective that traceability will achieve the objective of providing more security to the population. After the closing of the final text, it will be discussed in a public meeting of the directors of the National Health Surveillance Agency (Anvisa).

In addition to medication tracking, Abdenur spoke about the medication exemption project. “The average level of medication taxation in Brazil is 34%, while the world average is 6%. In some countries there is no taxation, ”said the ETCO Executive President.

Global pharmaceutical laboratory manager Eli Lilly, Grant Lindman, spoke about drug trafficking in several countries around the world. "First of all, we need to share the information," he said, citing education, regulation, capacity building and international cooperation as fundamental factors in combating this illegal trade. “Drug trafficking is just as serious as drug trafficking. It is a big challenge, but if we work together, we can have good results. ”

The director of the legal group of the Brazilian Association of the High-Tech Industry of Medical-Hospital Equipment, Products and Supplies (Abimed), Mariângela Vassalo, explained that the major problem of drug piracy is that, unlike some other products, this can pose a serious risk to the health of the population. “We have to work on the exchange of information so that we can identify and prevent cases of piracy in this area. When we talk about combat it is because something has already happened, and something must be done to anticipate this problem. ”

In the next panel, the president of the National Forum Against Piracy and Illegality (FNCP), Edson Vismona, highlighted the importance of a constant process of integration of the public power. “Today, each sphere has its competence, and working to add them takes away the space for organized crime,” he argued.

Data from the Federal Highway Police indicate that, between 2010 and 2013, 20,9 million units of counterfeit and adulterated drugs were seized. Manuel Hermeto Vasconcelos Junior, inspector of the PRF, said that the integration of forces between the highway, civil and Federal Revenue Police for the seizure of pirated goods is very effective at the borders. "At the regional level, it is interesting that there is a division of functions between each body, so that everyone knows where each team is working and combines intelligence actions", he added.

ETCO supports Parliamentary Front for Exemption from Medicines

Source: Portal Fator Brasil

The institute's executive president, Roberto Abdenur, was at the launch event on April 17 (Thursday).

Attentive to taxation and piracy issues in the medication sector, the Brazilian Institute of Competitive Ethics (ETCO), through its executive president, Roberto Abdenur, participated on April 17 (Wednesday), in Brasília, in the launch of the Parliamentary Front for Exemption from Medicines. The event marks the beginning of the work of the front, which aims to discuss the reduction of taxes on medicines in the National Congress, an initiative of federal deputy Walter Ihoshi (PSD-SP).

The tax burden on medicines in Brazil is one of the highest on the planet. They are 33,9% of the final price, while the world average is 6,3%. This means that, for every R $ 10 paid in the purchase of medicines, R $ 3,39 refers to taxes.

For Abdenur, the creation of the Parliamentary Front for Exemption from Medicines meets the old claim of the sector. ? We understand that the high tax burden on medicines in Brazil is a complex issue, which will have an important forum for discussion and proposing solutions at the front.?

Profile - The Brazilian Institute of Ethics in Competition, ETCO, is a civil society organization of public interest (OSCIP) founded in 2003 with the objective of identifying, discussing, proposing and supporting actions, practices and projects that result in concrete improvement of the work environment. business in Brazil. To this end, it acts to influence decision makers to adopt measures aimed at reducing tax evasion, illegal trade and informality, in addition to actions to simplify the tax system and combat corruption and other misconduct. The institute seeks to maintain a strong presence in the Brazilian business and political circles in order to create mechanisms and tools that strengthen competitive ethics. There are three action strategies: to foster studies on the factors that encourage these deviations in conduct; propose and support initiatives, actions or changes in legal texts and administrative practices; and to develop and support actions to raise public awareness about the harmful social and economic effects and the dangers of these illegalities and social leniency with these deviations from ethical behavior.