Postat la: 13.02.2014 - 10:30 | Scris de: Ziua News
A counterfeit medicine traffic network operates in Romania, jeopardizing the life of people who suffer from Hepatitis B and C. The Romanian authorities, from the National Medicine Agency to the legal structures, police and prosecutors, are all overwhelmed.
By Voichita Rascanu
The National Medicine Agency (ANMDM) was unable to block the trade of counterfeit interferon, in spite of the Roche warning, while the remaining competent authorities are unable to enforce the criminal law effectively, sanctioning and punishing those who jeopardized public health. ANMDM admitted the knowledge of the compromised medicine that contained water and glucose instead of interferon but, nevertheless, allowed it to be traded on the free market.
The Bucharest Police stammered
The Bucharest Police and Prosecutor's Office announced a case has been opened for economic crimes in the counterfeit medicine scandal. In fact, the correct legal charge should have been attempted murder. According to Article No. 176 of the Criminal Code, the capital murder is the murder committed in several circumstances, one of them being b) of two or more individuals. The attempted capital murder is defined by knowingly and voluntarily jeopardizing the lives of several individuals, the patients suffering from Hepatitis B and C in this case. Both the companies that carried the traffic and the authorities that took no measure upon being notified about the existence of the counterfeit medicine may be easily charged with attempted capital murder.
The effects of the interferon contained by Pegasys have been widely admitted by the authorities: "The interferon prolongs the life of people suffering with Hepatitis B and C, whilst in its absence the disease may significantly develop", according to Anca Crupariu, representative of ANMDM Romania. In other words, the absence of the interferon causes a shorter life for people suffering from Hepatitis B and C. The situation became even more serious as the Ministry of Health issued a notice warning Pegasys users to urgently meet their doctor "in order to establish a proper therapeutic treatment plan".
The Bucharest Police and Prosecutor's Office, by announcing a case has been opened for tax evasion and counterfeit products trade, demonstrated how they lack legal brain. First, the competent authorities do not possess data on any tax evasion in this field committed in Romania or by Romanian citizens. In order to prove the money laundering, the prosecutors should first demonstrate the illegal source of money, which implies demonstrating and proving an entire illegal international network! Worse, police officers and prosecutors intend to carry investigations only for counterfeit medicine trade, charge which is not defined by any means by our criminal code, a charge which is far too soft for such an action and proof that the intent is to delay and bury the case. According to Article 300 of the Criminal Code, the counterfeit product trade is defined by "trading products obtained from counterfeiting activities or the unlawful use of a trademark". In other words, if an individuals labels a home-made wine as a well-known wine, he may be charged with counterfeit product trade.
Syringes manufactured in improper conditions
Another element left out by the police and prosecutors was the actual condition of the counterfeit Pegasys syringes. Surprisingly or not, the prosecutors did not take into account that syringes contained no information or data on the place and facility, method or people involved in manufacturing the syringes, as the simple production and trade of the syringes in improper conditions jeopardize the life of patients who could get HIV, AIDS or a viral hepatitis from using the needle.
According to the EC Directions, each production facility must have its own personnel with the capacity to provide pharmaceutical quality. The personnel must take permanent training courses, establish hygiene programs designed in accordance with each activity - including procedures on the health conditions, hygiene and outfit of the employees, the building and the production equipment to be compliant with severe hygiene regulations in order to avoid all contamination risks or negative effects on the product quality. In addition, the buildings, areas and equipment used must be certified by the competent authorities. The end product must be verified by an independent consultant, certified as such, who has full access to the quality control laboratory in order to run the necessary checks for raw and packaging materials and who is also competent and allowed to test the intermediary and end products. External laboratories may also be used. The end product verification, prior to its trade and performed in keeping with the quality control system provisions, will also contain data on the production terms, production-stage controls, production documents verification and the product compliance with its own specifications.
Samples of each end product medicine will be kept for at least a year upon its expiry date. The EC Directions also stipulate that all human use medicine production operation will be the object of a written agreement between producer and the company that ordered it, agreement which establishes each party's obligations. The producer shall comply with all good practice guidelines and principles and will be subject to inspections of the competent authorities.
ANMDM was informed on the counterfeit medicine two months ago
The medicine produced by Roche LTD Basel and its subsidiary Roche Romania are imported solely by Roche Romania and distributed by Farmexpert, Mediplus, Farmexim and Polisano, as well as 10 other minor distributors.
Roche Romania announced, upon the scandal broke out, that they had warned ANMDM as early as September on the identification of a counterfeit Pegasys package in Germany. "Roche Romania SRL informed ANMDM in September 2013 on the identification of a counterfeit Pegasys package by the quality control department of F. Hoffmann - La Roche LTD Basel in Germany. Subsequent to the notification, we maintained a permanent line of communication with ANMDM referring to the potential presence of counterfeit Pegasys lots in Romania. We hereby inform you that no confirmation has been made by November of counterfeit Pegasys in Romania."
The Romanian ANMDM disagrees and admits not only the existence of medicine lots suspected of being counterfeit prior to November, but also their failure to inform all those concerned effectively. According to Anca Crupariu, spokesperson for ANMDM, "On October 24 we communicated the field professionals, like the Ministry of Health, CNAS (National Medical Insurance Agency), professional doctors' and pharmacists' organisations. At that time we suspected there were counterfeit Pegasys lots. When it became certain that there were counterfeit medicine lots traded in Romania and labelled as Pegasys 180 we published a notification to our patients". Cruprariu eventually admitted that three lots have been identified and "it has been decided that the respective lots would be quarantined and a warehouse verification would be run. The lots are numbered B1299B03, B1297B11, B3008BO3."
More than two million Romanians are infected with Hepatitis B or C virus
According to recent estimates conducted by health professionals, more than two million Romanians are infected with Hepatitis B or C virus, ranking Romania on the first places in Europe in the field. Despite the alarming number, doctors believe that the actual number is higher than presented in the estimates, because not all people who suffer from Hepatitis B or C have been diagnosed. Among the patients registered with Hepatitis B or C, roughly 4,000 of them are treated with the interferon pre-filled Pegasys syringes. Less than 1% of the people who suffer from Hepatitis C and approximately 1% of the people who suffer from Hepatitis B have access to the treatment.
Pegasys, best selling medicine in Romania
According to the data provided by Cegedim Romania, a company specialised in pharmaceutical services, Pegasys is the best selling medicine in Romania in terms of value. Between June 2012 and June 2013 this medicine ranked first in a top ten best selling medicines in terms of value, cashing in approximately LEI 193.33 millions (roughly EUR 43,000,000).
Medicine black market: EUR 10.5 billions
According to a recent survey ordered by Pfizer, Western Europeans pay EUR 10.5 billions per year for black market medicines, many of which are counterfeit. The pharmaceutical companies registered EUR 10.8 billions in sales in 2012, taking into consideration only the medicines sold by pharmacies to patients. The counterfeit medicines often contain toxic ingredients that jeopardize health, warns WHO. A control carried for two months until December 2012 all over the European Union discovered 34 millions of counterfeit pills. Statistics shows that 62% of the online purchased drugs are counterfeit or below standards. Interpol terminated in 2012 a network specialised in the traffic of drugs for cancer treatment, antibiotics, erectile dysfunctions, diet and even food supplements. The 79 arrested individuals alone trafficked medicines worth EUR 10.5 millions.
The distributors and resellers' partnership
Representatives of the pharmacists claim that the counterfeit medicines issue is global and all countries fight against it. Clara Elena Popescu, Vice-President for Romanian Pharmacists' Association, declared that it is a common practice for medicines to be delivered by producers containing a registration series, lot number and authentication certificate and to reach the warehouses or even pharmacies based on the documents alone, without even opening the box. "Somehow, somewhere, from the producer to the distributor, there is a specialised mob group, most probably helped by an employee of the distributor, that replaces authentic medicines with counterfeit medicines." More, it is impossible for the pharmacists and patients to know an authentic medicine from a counterfeit one because "usually, the boxes and packages are identical, one could only see better on opening the box. One cannot open hundreds of thousands of boxes and packages, not to say that no patient would buy a unsealed package of medicine", Popescu added.
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