Fecomércio SC affirms rejection of PEC of medicines

Fecomércio SC understands as wrong the rejection of the Proposed Amendment to the Constitution (PEC) 115/2011, which prohibits the collection of taxes on medicines for human use, last Wednesday (12th), by the Commission for Constitution, Justice and Citizenship (CCJ) of the Federal Senate. With the rejection of the so-called PEC dos Remédios, the pharmaceutical sector continues to be penalized with a high tax burden. Fecomércio will ask the Santa Catarina bench in the Senate (and will ask the other state trade federations to do the same with their representatives) to file an appeal at the table asking for the PEC's appreciation by the plenary.

(Source: Portal da Ilha | 14/11)

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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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A public health issue

By Roberto Abdenur

An industry as poignant as it is nefarious puts the health and even the lives of thousands of Brazilians on the tightrope. Annually, it seizes large amounts, ranging between R $ 5 billion and R $ 8 billion, from the sale of medicines that result from theft, contraband, distribution of false or illegal drugs.

To get an idea of ​​the strength of this “risk industry”, only in the first half of 2011 the seizure of goods for smuggling, counterfeiting and piracy increased by 51% compared to the same period in 2010, according to the Federal Revenue Service. A data in itself alarming, but it gets even worse when you look only at the seized medication loads and arrive at the frightening growth of 180,5% compared to the previous year. A dishonorable third place, behind only illegal ammunition loads, which increased by 445%, and bags and accessories, which grew by 423%.

It is not necessary to be a qualified economist to understand the maxim that there is no supply without demand. With this quick association, the results of a survey carried out by Ibope Inteligência for Interfarma at the end of 2011 are not surprising. After listening to 2.002 people across the country, the study revealed that a fifth of the Brazilian population buys medicines without a prescription. In the Northeast, this population rises to almost a quarter, more precisely 24%.

As the Minister of Justice, José Eduardo Cardozo, said in an event held in Rio de Janeiro, the truth is that people buy. Whether for ease, price, convenience, Brazilian citizens are exposed to unimaginable risks, especially when the precariousness with which “piracy pills” are manufactured is known.

The problem, which is difficult to solve, has mobilized time and minds not only in the Ministry of Justice and the Federal Police. The National Health Surveillance Agency (Anvisa) is engaged in this fight; the National Council for Combating Piracy and Intellectual Property Offenses (CNCP); parliamentarians and civil society organizations, such as the Brazilian Institute for Competition Ethics (ETCO) and the National Forum against Piracy and Illegality (FNCP). Each, in his specialty, has done much to combat this evil that plagues the country.

But in view of the figures presented above, it is clear that the repression of crime, alone, falls far short of the pressing need to eradicate harmful informality.

Commendable measures - such as the partnership between Anvisa and the Ministry of Justice, for the seizure of illegal drugs; interdiction of establishments and arrest of those responsible; and the Strategic Frontier Plan, which articulates several government forces in the surveillance of the 17 thousand kilometers of Brazil's land border - must necessarily be accompanied by other preventive actions.

Investing effectively in raising public awareness about the harms of illegal remedies and the risks to which they are exposed is one of the most urgent measures. Joining efforts around the production of educational campaigns is a mission that imposes itself on the players in the sector.

Drug screening is another factor of great importance. In a statement released in December, the National Health Surveillance Agency (Anvisa) stated that it has already decided on the guidelines that will guide the implementation of the National Drug Control System, as determined by Law 11.903 / 09. Tracking, among other advantages, will help in combating 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.

We are not facing a simply economic problem. Undoubtedly, the honest and legal drug industry is affected and the government loses revenue that could be used to improve services to the population. But the case of medicines opens up a bigger problem, a problem of public health, of life, of citizenship. Brazil cannot and should not continue to run this risk.

ETCO receives Interfarma as an associate

The Executive President of Interfarma - Association of the Pharmaceutical Research Industry, Antônio Britto, and the Executive President of the Brazilian Institute of Competitive Ethics (ETCO), Roberto Abdenur, sealed, on October 18th, an agreement by which Interfarma returns to be part of the Institute's Sectorial Chamber of Medicines, which also has Eurofarma, Medley and Cristália.

After a period of negotiations, Interfarma returns to the membership of the ETCO Sectorial Chamber of Medicines. From now on, the companies associated with Interfarma that were already part of the Chamber will be represented by the Association in the decisions and actions developed by ETCO.

“The re-association of Interfarma, which is arguably the legitimate interlocutor of the 43 companies it currently represents, will bring an operational gain that will be reflected in greater effectiveness in the defense of competitive ethics and in combating informality, counterfeiting and smuggling, which unfortunately are strongly present in the medicine sector ”, points out Roberto Abdenur.

For the Executive President of Interfarma, Antônio Britto, “it is, in fact, a new stage in the relationship with ETCO, since many of the companies represented by us have always been associated with the Institute”. He also explains that “Interfarma associates account for almost 80% of the reference drugs and for more than 40% of the generics, that is, more than half of the drugs sold in the country, and the work developed by ETCO is extremely important in this sector , where illegality is a risk to public health ”.

The ETCO Sectorial Chamber of Medicines, now composed of Interfarma, Eurofarma, Medley and Cristália, was created in 2005, based on a set of measures identified by the study “Informality in the Pharmaceutical Sector: Barriers to the Growth of the Brazilian Economy and Health Risk Pública ”, conducted by McKinsey & Company and Pinheiro Neto Advogados. This was one of the Institute's main contributions to the fight against illegalities practiced in the Brazilian medicine market. With the same objective, ETCO and the companies associated with the Chamber delivered to Anvisa the Final Report of the pilot project of the Electronic System for the Tracking and Authenticity of Medicines, aiming to support the agency in the regulation of the National Medicines Control System.

“ETCO is a reference in the struggle for more justice and seriousness in the country, and has been responsible for the most successful initiatives aimed at abandoning old practices that are incompatible with the social and economic development of Brazil”, concludes Britto.

False remedies, an evil still without cure

Author: Geórgea Choucair

Source: Diário de Pernambuco Online - Recife / PE - 03/01/2010

The government, industry and drug traders have joined forces to fight illegality in the drug trade in the country, which moves from R $ 6 billion to R $ 8 billion a year, according to an estimate by the Brazilian Institute of Ethics in Competition (Etco). The drugs sold in Brazil are on track to gain a two-dimensional bar code, also called Datamatrix, which will be the technology used to guarantee the traceability of the units. The National Health Surveillance Agency (Anvisa) intends that technology is the main tool to guarantee the traceability of products, that is, it will make it possible to recover historical and geographical information about the path taken by medicines from their production to delivery to the consumer.

From January to October this year, Anvisa seized 329 tons (30,55 boxes) of unregistered, counterfeit, smuggled or expired drugs. The seizure was made in partnership with the Federal (PF) and Rodoviária Federal (PRF) police. The favorites of counterfeiting gangs and smugglers are the drugs against sexual impotence, recommended for the treatment of erectile dysfunction, for guaranteeing high profits and being among the best selling drugs in the country. They were present in most of the seizures made by Anvisa throughout this year.

The price of drugs against erectile dysfunction is one of the main attractions for gangs. The box with two 50mg tablets of the main brands - Viagra, by Pfizer, and Cialis, by Eli Lilly - costs, on average, R $ 55. “In addition, they are on the list of the best selling medicines in the country”, observes André Franco Montoro Filho, president of Instituto Etco, which has a Sectorial Chamber of Medicines whose objective is to combat unfair competition in the sector (such as counterfeiting, smuggling and any irregular sale). The illegal sale of medicines, says Montoro Filho, is responsible for about 27% of the drug market in the country.

The internet is an ally of trafficking in counterfeit drugs, especially drugs to combat impotence. The anonymity of the seller, coupled with the shame of looking for official means to address the problem of sexuality, gives strength to the online illegal market for medicines. “Sales through websites are a concern. But in Brazil, this business is still small when compared to the illegal drug trade over the Internet in the United States and Europe ”, observes the president of Etco.

Security - Federal Law 11.903, enacted by the government earlier this year, mandates that drug manufacturers include a safety device in their packaging that allows the drug to be traced from its manufacture to the consumer. Drug manufacturers have three years to adapt to the measure. The first year expires in January 2010.

In June, Etco did a pilot test of a two-dimensional code printed directly on the box, which allows it to store more than 64 characters about the manufacturer, such as batch, product, date of manufacture, validity and the serial number. The code is a kind of barcode evolved with dots and a numerical sequence. The test was carried out in 75 thousand units of seven laboratories, in partnership with Anvisa. ”It's like the chassis of an automobile. The result was a success, as we were able to track it without major changes in production, industry and retail distribution ”, celebrates Montoro Filho.

Unlike the common barcode, which is visible and contains only one number, the two-dimensional can store thousands of information, such as numbers, letters and other data. According to Anvisa, all will be gathered in the Unique Identifier of Medicines (IUM), which will be in each unit sold and will be printed on security labels produced specifically for this purpose.
 

ETCO supports drug tracking system

Source: Maxpress, 12/05/2008

The high degree of informality that exists in the drug sector harms public health and does significant damage to the development of the economy

A consensus is forming in Brazil and in the world on the need to track various products. But there is a sector in which the need to certify the origin and authenticity of its products is presented as fundamental and a priority: that of medicines.

On April 30, the Brazilian Institute of Ethical Competition (Etco), which brings together an important portion of the pharmaceutical industry, presented Dirceu Raposo de Mello, from the National Health Surveillance Agency (Anvisa), his suggestions on the system for tracking medicines, in view of the public consultation, which started on March 4. Over the past few months, Etco's sectorial medicine chamber, created in December 2005, has been working together with representatives of the sector to develop an architecture for a tracking and authenticity system that guarantees security for all links in the chain.

One of the great harms of informality present in the sector is the exposure of public health to risks. The use of inferior medicines and the administration of inadequate dosages deserve attention. "The dangers and losses resulting from drugs not manufactured according to the standards and procedures adopted by Organs controlling bodies are of incalculable dimensions", warns André Franco Montoro Filho, executive president of Etco. “Medicines manufactured without proper control, instead of curing, can even kill. Even if the extreme case does not occur, this type of medication can become ineffective, delaying and making treatment costs more expensive ”, he warns.

Informality, in addition to reducing the government's investment capacity, causes unfair competition between companies and hinders the growth of the sector. "The success of productive activities and economic growth depend on institutions, rules, uses and customs that provide adequate incentives, creating a good business environment", says Montoro Filho. "The support of the Brazilian Institute of Ethics in Competition for the drug tracking system aims at the search for ethics, combating fraud, counterfeiting and evasion in the sector, uniting all links in the chain."

Sectorial Chamber of Medicines


The Etco sectorial medicine chamber brings together 34 laboratories, which together invoice R $ 18,1 billion (66,5% of the pharmaceutical market), according to data from July 2007, and employ 28 thousand direct workers and more than 100 thousand indirect workers.

A study on informality in the sector commissioned by McKinsey in 2005 showed that the level of informality in the medication sector is alarming. According to the survey, 23% of the taxes due are withheld, 40% of the labor force in the sector is informal and 27% of the sales of drugs in the therapeutic classes surveyed are made through the illegal exchange of products. Since then, Etco has analyzed solutions available on the market for the implementation of systems for authenticity and drug tracking, in addition to promoting research on instruments and mechanisms that can help to reduce unfair competition.


 
Source: TemCura (online)

ETCO supports drug tracking system

Source: Quaero (online), 12/05/2008

Medicine and Health


 
The high degree of informality that exists in the drug sector harms public health and does significant damage to the development of the economy
A consensus is forming in Brazil and in the world on the need to track various products. But there is a sector in which the need to certify the origin and authenticity of its products is presented as fundamental and a priority: that of medicines.

On April 30, the Brazilian Institute of Ethical Competition (Etco), which brings together an important portion of the pharmaceutical industry, presented Dirceu Raposo de Mello, from the National Health Surveillance Agency (Anvisa), his suggestions on the system for tracking medicines, in view of the public consultation, which started on March 4. Over the past few months, Etco's sectorial medicine chamber, created in December 2005, has been working together with representatives of the sector to develop an architecture for a tracking and authenticity system that guarantees security for all links in the chain.

One of the great harms of informality present in the sector is the exposure of public health to risks. The use of inferior medicines and the administration of inadequate dosages deserve attention. "The dangers and losses resulting from drugs not manufactured according to the standards and procedures adopted by Organs controlling bodies are of incalculable dimensions", warns André Franco Montoro Filho, executive president of Etco. “Medicines manufactured without proper control, instead of curing, can even kill. Even if the extreme case does not occur, this type of medication can become ineffective, delaying and making treatment costs more expensive ”, he warns.

Informality, in addition to reducing the government's investment capacity, causes unfair competition between companies and hinders the growth of the sector. "The success of productive activities and economic growth depend on institutions, rules, uses and customs that provide adequate incentives, creating a good business environment", says Montoro Filho. "The support of the Brazilian Institute of Ethics in Competition for the drug tracking system aims at the search for ethics, combating fraud, counterfeiting and evasion in the sector, uniting all links in the chain."

Sectorial Chamber of Medicines


The Etco sectorial medicine chamber brings together 34 laboratories, which together invoice R $ 18,1 billion (66,5% of the pharmaceutical market), according to data from July 2007, and employ 28 thousand direct workers and more than 100 thousand indirect workers.

A study on informality in the sector commissioned by McKinsey in 2005 showed that the level of informality in the medication sector is alarming. According to the survey, 23% of the taxes due are withheld, 40% of the labor force in the sector is informal and 27% of the sales of drugs in the therapeutic classes surveyed are made through the illegal exchange of products. Since then, Etco has analyzed solutions available on the market for the implementation of systems for authenticity and drug tracking, in addition to promoting research on instruments and mechanisms that can help to reduce unfair competition.
 
 
* Source: TemCura (online)

Tips to protect yourself from counterfeit drugs and save your health

Source: O Serrano, 23/09/2007

Informality in the pharmaceutical sector and its risks to consumers' health are themes that have been in vogue in recent days, especially after the well-known siege of the gang that sold appetite moderators illegally. Other topics have also been widely discussed: - Danger of counterfeiting medicines; - The indiscriminate use of drugs that are often not prescribed by a medical professional.


The surveillance agencies have taken several actions to make consumers aware of the risks that the improper use of products from the illegal industry can generate.


The topic is not on the agenda of large newspapers for nothing: they are serious problems that endanger the lives of thousands of people, every day. For this reason, the Sectorial Chamber of Medicines of ETCO - Brazilian Institute of Ethical Competition, collaborating with this initiative, advises the consumer to be aware of the following tips, which may be useful when purchasing a medicine. Write down:


1) ONLY PURCHASE MEDICINES IN PHARMACIES AND DRUGS, preferably establishments you know. NEVER BUY MEDICINES AT FAIRS AND CAMELETS.


2) ALWAYS CHECK the medicine packaging:
The. The expiration date of the product is shown.
B. If the product name is well printed and can be easily read.
ç. If there are no tears, erasures or any information that has been erased or scraped.
d. The name of the pharmacist responsible for manufacture and the number of his registration with the Regional Pharmacy Council are stated.
and. The register of the responsible pharmacist must be in the same state in which the drug factory is located.
f. The number of the drug registration with the Ministry of Health is shown.


3) SERUMS AND SYRUPES MUST COME WITH SEAL. This is mandatory for all liquid medicines. DO NOT BUY medications with crumpled packaging, broken seals, labels that come off easily or are erased and smudged.


4) THE INSERT CANNOT BE A XEROX COPY. If the package insert is not original, do not accept the product.


5) ALWAYS DEMAND THE FISCAL NOTE from the pharmacy or drugstore. It must contain, in addition to the name of the drug, the batch number. SAVE WITH YOU the invoice, the packaging and the card or bottle of the medicine being used. They are your proof, in case of irregularity, for you to file a complaint.


6) JUST TAKE The informality in the pharmaceutical sector and its risks to the health of the consumer are topics that are in vogue in the last days, especially after the so reported siege to the gang that sold appetite moderators illegally. Other topics have also been widely discussed: - Danger of counterfeiting of medicines; - The indiscriminate use of drugs that are often not prescribed by a medical professional