Source: Baiana Medicamentos - 13/6/2008

From the industry to the hands of the consumer, medicines go a long way and do not always reach their destination. Thieves steal cargo. Counterfeiters change the formula.

The drug loses its effect and even harms the patient, but as of July 2009, all packaging must be tracked.

The boxes will be controlled and connected directly to a central computer, which will monitor the movement 24 hours a day.

The National Health Surveillance Agency talked for two months with doctors, pharmacists, consumers, manufacturers and distributors. It received 57 suggestions for new technologies to control the route of the products.

Now, a new stage begins: public hearings to decide which is the cheapest and most practical system, capable of guaranteeing that the medicine is safe. Anvisa's CEO, Dirceu Raposo de Mello, said there are many options.

For example, a special ink that only appears on the box reader if the medication is authentic or a dot code, which identifies each unit of the product. The consumer thinks it is good, but fears having to pay more.
Very expensive

"I think the medicine is already very expensive, I think I could do this screening, I think it is very good that this process be done, but without being burdensome on the consumer," says Ana Ribeiro, communications advisor.

According to Anvisa, the industry has no excuse to raise prices. You will spend less on insurance to transport medicines.

"The industry should in principle bear these costs, not least because there will be replacement costs which, today, it bears and, therefore, will be a mere replacement of technologies", says Dirceu Raposo de Mello, CEO of Anvisa. The information is from Jornal Hoje.

Source: http://atribunadigital.globo.com

For laboratories, a medicine chip will be a “heavy and unnecessary burden” if inspection does not improve

SAO PAULO - The Association of National Pharmaceutical Laboratories (Alanac) released, on Monday, a note to the press with observations on the measure of Anvisa (National Health Surveillance Agency) to implement a system for tracking medicines. The entity calls for other regulatory measures in the sector to make the new process work. The system will monitor the drugs from production to the final consumer, that is, until they arrive at the pharmacy shelves. The intention is to combat everything from tax evasion to illegal sales and cargo theft.

The annual cost of the process, which includes the placement of bar codes, numbers, points or chips in the medicine packaging, is R $ 70 million. For the laboratories, the costs are "heavy" and "unnecessary" if there is no reinforcement in the inspection by the Ministry of Health. The entity also asks for a test of the new system to be made to ensure that it works, before forcing the industry pharmaceutical company to make all this investment.
'For Alanac, the implementation of the system of traceability and authenticity of medicines should be carried out by conducting pilot tests throughout the pharmaceutical chain, to ensure the viability, effectiveness and consistency of the system. In addition, the deadline for the complete implementation of the system must be compatible with the technical needs of the pharmaceutical industrial sector, since it will directly impact the Good Manufacturing Practices of each changed line (need to readjust production lines with possible change / inclusion of equipment. ) ”, Says the official note.

The laboratory document continues:
“With regard to Anvisa, it is expected that it will establish new regulations and adapt the existing ones to the new system for the entire pharmaceutical chain and define what mechanisms it will use to inspect any cargo theft or counterfeiting in it. For the effective functioning of the system, it is essential that ANVISA and the local Visas have a specific and effective infrastructure for inspection. ”

The owners of the laboratories also took the opportunity to criticize the government's inspection. For them, before implementing a high-tech tracking, it would be better to expand the inspection:
“For Alanac, it is clear that there is a very big problem of insufficient supervision of the entire distribution chain, which will prevent the adoption of any technology for traceability and authenticity, since it will not be the technology that will prevent the loss of traceability. and / or the appearance of the illicit pharmaceutical product. Inspection will minimize these problems. Thus, Alanac believes that prior to the adoption of a new technology for traceability and authenticity, it is necessary to consolidate the role of the supervisory body of the entire drug distribution chain, as without this the actions and technologies determined by the future Resolution of they will do nothing to achieve the proposed objective, resulting only in additional burden to the pharmaceutical industry and minimal benefit to the consumer with regard to the reduction of the existing health risk ”, concludes the text of the pharmaceutical industry.

Source: http://oglobo.globo.com

Starting on the production line, from the factories, through the trucks that lead to the distributors and until the time of sale at the pharmacy counter, the route of the medicine boxes will be monitored.

Government and manufacturers believe that, thus, they will have a powerful instrument to control the medicines sold in the country, avoiding tax evasion, preventing theft of cargo and illegal sale of medicines. The price of tracking, however, tends to be diluted throughout the chain, from the manufacturer to the buyer. That is, at least part of the bill must be left to the consumer.

The decision to trace the medicines was taken in March by the National Health Surveillance Agency (Anvisa). Last Monday (5), the public consultation ended for the presentation of criticisms and suggestions on the minimum requirements to define how the monitoring and authentication of medicines will be.

Brazil started at the front and was the first country to discuss the issue, but it is not alone. Two weeks after the start of the local public consultation, the European Union and the United States launched similar consultations. "It is a worldwide trend and we will be able to work with Americans and Europeans in this system", says Dirceu Raposo, president of Anvisa.

The concern of governments, industry and consumer protection and ethics bodies is the exponential growth of drug-related crimes. According to the Brazilian Institute of Ethics in Competition (Etco), informality in the sector is alarming. In Brazil, tax evasion is 10% on companies' revenues, equivalent to US $ 1 billion. Worldwide, 30% of the active ingredients of medicines sold are counterfeit.

The incidence of counterfeit drugs in Brazil is also increasing, the majority originating in Southeast Asia. The figures for cargo theft as a whole are growing annually, much of it targeting trucks with medicines.

System should start in 2009

For strategic reasons, the industry does not reveal how much it loses with the assaults, but the president of the Association of the Pharmaceutical Research Industry (Interfarma), Gabriel Tannus, has an indicator of the scale of the problem: “Insurance companies refuse to take out insurance pharmaceutical cargo if transport is not monitored by satellite and followed by armed escort ”.

The idea is to place some type of instrument in the packaging - barcode, dots, numbers, or chips - that will identify the medication and can be sent via the internet or radio frequency to a central computer of the manufacturer, which will store the data. Anvisa will have access to information whenever it deems necessary.

In 30 days, the agency intends to analyze the suggestions presented in the public consultation. By the end of April, 57 contributions had been sent. Anvisa's goal is to implement the system in the first half of next year.

The measure was suggested by the Etco Institute, whose inspiration came from the flow control system implemented by the Federal Revenue in breweries, which practically ended the sector's evasion.

For the president of the institute, André Franco Montoro Filho, when the system is implemented, it will have a ripple effect of good news. The public authorities - particularly states and municipalities - recover the tax evasion, the health authorities improve the control of medicines with repercussions on public health, the industry ceases to bear theft losses and unfair competition and consumers are guaranteed to buy a quality medicine. “It will be a win-win system. The measure will not be able to end all irregularities, but it is an important step to contain them ”, sums up Montoro.

Preliminary calculations indicate that this process will cost R $ 70 million per year, since the estimated cost is R $ 0,06 per unit sold. In Brazil, 1,4 billion packages are sold per year. According to Dirceu Raposo, from Anvisa, companies will reduce the expenses they have today with insurance, escorts and security measures already adopted. This is the case of the “scratch cards” that come in medicine boxes and the seal of the packaging. This cost reduction will offset the investment in tracking.

Anvisa does not want cost transfer

Cost sharing should be the most controversial part of the process. After all, Anvisa doesn't want the bill over to the consumer. Currently, about 70% of medicines have their prices controlled and in this relationship are the most targeted by counterfeiters and thieves. The other 30% can be increased according to the manufacturer's interest.

The president of Anvisa already has the answer: "The industry, which will have less expenses, must pay the bill". But Gabriel Tannus, from Interfarma, admits that the cost tends to be diluted in the chain and may be left to the consumer. “We are not going to be naive. It will cost and we have to find a way to divide it. Perhaps the consumer will pay a small part of the bill ”.