The European Commission will present the much-delayed “pharma package” on December 10 at a press conference.
Ton van Liero, spokesman for Gunter Verheugen, European Commissioner for Enterprise and Industry, told me, “We foresee a press conference on Wednesday on the pharma package.”
Moreover, the Commission announced that the College of Commissioners (27 Commissioners) will be presented with it next Wednesday.
Commission spokesman Amadeu Altafaj Tardio told journalists: “On the agenda of the Commission meeting next Wednesday, will be a major pharmaceutical package. It has been subject of many draft directives, amendments, existing directives and Commission communications by Mr. (Gunter) Verheugen and various proposals and drafts and regulations, so the whole package that is for pharmaceutical industry.”
Earlier today addressing a joint press conference with health ministers from G7 countries (Canada, France, Germany, Italy, Japan, UK, US), Mexico and the World Health Organisation, European Health Commissioner Andrroulla Vassiiou also had expressed hope that the pharma package will come out soon.
The Commissioner was hosting Global Health Security Initiative (GHSI) to forge stronger global collaboration on health security.
VASSILIOU ADDRESSES DIFFERENCES
Replying to a question about disagreements within the Commission, Commissioner Vassliou said, “It (Pharma package) is one of the most difficult packages and it is natural that all cabinets are very interested about it and there is a lot of discussion so that our purpose is to reach a final agreement on a package which will be in agreement with everybody,” adding, “I am hopeful that it will come up with something which will be satisfactory to everybody and useful to everybody.”
The European Commission has repeatedly delayed since October 21, the publishing draft regulations which could overhaul the pharmaceutical sector, amid rumours that divisions within the Commission are leading to the delays.
VERHEUGEN STAYS CONFIDENT
European Commissioner for Enterprise and Industry Gunter Verheugen had denied that his package of proposed new regulations for the pharmaceutical industry will be substantially altered despite its publication being delayed but APM understands there are disagreements within the College over such subjects as banning the repackaging of medicines, which is widely practiced by parallel traders.
The pharma industry has been pushing to ban repackaging of medicines saying it is the only way to stop trade in counterfeit products.
But supporters of parallel trade believe it could damage the legitimate practice of traders buying low-price drugs in markets such as Greece and selling them at a profit in other countries where they can command a higher price.
A report published recently on the website of the Commission's directorate general for Enterprise and Industry said that repackaging and relabelling medicines posed an inherent risk to patients but banning the practice would result in a dramatic reduction in the level of parallel trade and in the loss or redeployment of some 10,000 jobs across Europe.
The sources recently told me that a revamped package is now being prepared that will not ban repackaging. "Those proposals are history," said one.
This is in line with comments from a Commission spokesman earlier. "There is no ban foreseen on repackaging or relabelling ... Parallel trade is a legal economic activity in the European Union (and) the commission does not intend to change that."
INFORMATION TO CONSUMERS FACTOR
But other measures in the pharmaceuticals package are also controversial, such as a proposal to allow companies to provide information on their drugs to patients, which some commentators believe is tantamount to permitting direct-to-consumer advertising.
The Association Internationale de la Mutualité, Health Action International (HAI) Europe and Medicines in Europe Forum today in an open letter to European Commission President Jose Manuel Barroso said: “The proposals on “information to patients” represent yet another tactic to delay generic competition by enabling the pharmaceutical companies to communicate directly to the public on their respective prescription-only medicines, thereby building "brand loyalty" and market share for their own originator products at the expense of affordable medicines for the public.”
Greg Perry, Director General, European Generic Medicines Association (EGA) had told me: "We understand the reason for the delay is due to lack of agreement on ITP (information to patients virtual network) proposal."
Perry said the EGA's main concern was now that the proposed legislation will not make it through this session of the European Parliament, particularly the pharmacovigilance package which is "a good proposal in terms of improving patients safety, harmonisation and better regulation."
Showing posts with label PHARMACEUTICALS. Show all posts
Showing posts with label PHARMACEUTICALS. Show all posts
Friday, December 5, 2008
Thursday, October 2, 2008
Pharmaceutical companies pay for drug authentication service at dispensing point
Pharmaceutical companies are paying an annual subscription for registration and maintenance of their unique product codes into the Aegate database to protect the consumers against counterfeit or substandard pharmaceuticals according to Aegate sources.
The pharmaceutical companies have access to add additional safety or security information into the database about their products at any time. Pharmacies are provided with Aegate's authentication service free of charge to ensure that for patient safety reasons cost is not a barrier to use, added Aegate.
The system was brought into focus with the presentation of an independent report at the European Parliament premises recently by Françoise Grossetête, MEP.
The report corroborated that Aegate's drug authentication service is 100 percent reliable and effective and keeps consumers fully protected against counterfeit or substandard pharmaceuticals when their pharmacist authenticates their medicines at the point of dispensing.
Speaking at the occasion, Professor Dr. Steven Simoens, Katholieke Universiteit Leuven, Belgium, confirmed: "Our findings verify that Aegate's patient safety communications service is 100 percent effective in ensuring that the drugs pharmacists dispense to patients are fit for purpose and safe."
The independent market analysis of "The reliability and impact of drug authentication at the point of dispensing" was carried out by Professor Simoens, The Research Centre for Pharmaceutical Care and Pharmaco-economics at the Katholieke Universiteit Leuven, Belgium.
According to the study details provided, the retrospective analysis included 114 pharmacies in Greece and 658 in Belgium. In day to day operation approximately 20 percent of pharmacies in Belgium and Greece are using the system with another 20 percent waiting to receive the technical upgrade to their software.
On the question of conflict of interest, the University of Leuven said in comments on the commercial contract, "the authors have no conflicts on interest that are directly relevant to the content of this manuscript." Moreover, the study carried out under a non disclosable commercial agreement with the University of Athens took two months to complete, the statement added.
SUPPLY CHAIN SECURITY
According to experts present at the presentation there are two approaches to supply chain security:
- authentication (such as Aegate system)
- track and trace
There are many companies in the US preparing to develop a track and trace system but the US does not yet have unique bar-coding so it is impossible to install. A decision on this approach by the FDA is being continually put back and is now expected by 2011 but it was confirmed by Aegate that with regards to authentication approach, "there is no other operating authentication system in the world today."
Dr. Guido Hoogewijs, General Manager of The Association of Belgium Pharmacists (APB), said: "The Aegate system is allowing us to strengthen our efforts by providing additional tools to filter out packs that are not authentic, that have just been recalled, just expired or are about to expire."
Hoogewils reiterated the concern of the Belgian pharmacists to only deliver pharmaceuticals of impeccable quality to their patients saying, "They have been financing and operating a Medicines Control Laboratory for the past 50 years in order to filter out substandard products from the market,"
Asked to comment on why the study was conducted only in Belgium and Greece, while Pharmaceutical Group of the European Union (PGEU) has 30 European members, PGEU in a statement explained, "Belgium, Greece and Italy (the three countries in which Aegate is operating) are the only three EU countries where by law all reimbursable pharmaceutical prescription items must contain a unique number on the individual drug package. (Similar to a passport number but on medicines). It is this number that creates the security."
John Chave, Secretary General, PGEU said: "Pharmaceutical safety is of fundamental importance for PGEU members and is a critical issue on the EU health agenda. Initiatives that have the potential to reduce the risk of counterfeits and promote patient safety are welcome."
HOW IT WORKS
Aegate explained that it provides drug manufacturers, pharmacists and their patients with a real time communication system that operates at an individual item level. Each pack of medicine is given a unique machine-readable identification number, known as unique serialisation. Using one of a number of technologies, including RFID, 1D or 2D barcodes, items are scanned as they are dispensed.
Allowing the pharmacist to check expiry dates and recall information, and provide updated patient care advice, the system ensures pharmacists receive product safety information more rapidly added Aegate. Currently, communications are achieved by fax or post and can reach pharmacies after drugs have been dispensed. The system also allows the authentication of the origins of medicines, thereby protecting against stolen and fake drugs.
PAN-EUROPEAN COVERAGE
With patient safety becoming an increasingly important issue and counterfeit drug sales forecast to hit USD 75 billion by 2010, Professor Simoens concluded: "The full impact of authentication processes will only be realised if such systems are applied fully within and across countries. We believe policy makers on a European and global scale should consider these findings and enact the necessary legislation to introduce drug authentication processes based on mass serialisation technology in community pharmacies."
Aegate has commenced roll-out in a new country every eight months since the technology completed development in 2006 and the next country will be announced shortly Aegate said. Currently in operation in Belgium, Greece and Italy, the system has so far this year scanned more than 24.5 million packs of drugs across Europe according to Aegate.
Urging others to follow the role of Belgium and Greece, Gary Noon, CEO of Aegate, said: "Industry and Governmental organisations now need to step up and demonstrate a similar level of commitment to patient safety."
The pharmaceutical companies have access to add additional safety or security information into the database about their products at any time. Pharmacies are provided with Aegate's authentication service free of charge to ensure that for patient safety reasons cost is not a barrier to use, added Aegate.
The system was brought into focus with the presentation of an independent report at the European Parliament premises recently by Françoise Grossetête, MEP.
The report corroborated that Aegate's drug authentication service is 100 percent reliable and effective and keeps consumers fully protected against counterfeit or substandard pharmaceuticals when their pharmacist authenticates their medicines at the point of dispensing.
Speaking at the occasion, Professor Dr. Steven Simoens, Katholieke Universiteit Leuven, Belgium, confirmed: "Our findings verify that Aegate's patient safety communications service is 100 percent effective in ensuring that the drugs pharmacists dispense to patients are fit for purpose and safe."
The independent market analysis of "The reliability and impact of drug authentication at the point of dispensing" was carried out by Professor Simoens, The Research Centre for Pharmaceutical Care and Pharmaco-economics at the Katholieke Universiteit Leuven, Belgium.
According to the study details provided, the retrospective analysis included 114 pharmacies in Greece and 658 in Belgium. In day to day operation approximately 20 percent of pharmacies in Belgium and Greece are using the system with another 20 percent waiting to receive the technical upgrade to their software.
On the question of conflict of interest, the University of Leuven said in comments on the commercial contract, "the authors have no conflicts on interest that are directly relevant to the content of this manuscript." Moreover, the study carried out under a non disclosable commercial agreement with the University of Athens took two months to complete, the statement added.
SUPPLY CHAIN SECURITY
According to experts present at the presentation there are two approaches to supply chain security:
- authentication (such as Aegate system)
- track and trace
There are many companies in the US preparing to develop a track and trace system but the US does not yet have unique bar-coding so it is impossible to install. A decision on this approach by the FDA is being continually put back and is now expected by 2011 but it was confirmed by Aegate that with regards to authentication approach, "there is no other operating authentication system in the world today."
Dr. Guido Hoogewijs, General Manager of The Association of Belgium Pharmacists (APB), said: "The Aegate system is allowing us to strengthen our efforts by providing additional tools to filter out packs that are not authentic, that have just been recalled, just expired or are about to expire."
Hoogewils reiterated the concern of the Belgian pharmacists to only deliver pharmaceuticals of impeccable quality to their patients saying, "They have been financing and operating a Medicines Control Laboratory for the past 50 years in order to filter out substandard products from the market,"
Asked to comment on why the study was conducted only in Belgium and Greece, while Pharmaceutical Group of the European Union (PGEU) has 30 European members, PGEU in a statement explained, "Belgium, Greece and Italy (the three countries in which Aegate is operating) are the only three EU countries where by law all reimbursable pharmaceutical prescription items must contain a unique number on the individual drug package. (Similar to a passport number but on medicines). It is this number that creates the security."
John Chave, Secretary General, PGEU said: "Pharmaceutical safety is of fundamental importance for PGEU members and is a critical issue on the EU health agenda. Initiatives that have the potential to reduce the risk of counterfeits and promote patient safety are welcome."
HOW IT WORKS
Aegate explained that it provides drug manufacturers, pharmacists and their patients with a real time communication system that operates at an individual item level. Each pack of medicine is given a unique machine-readable identification number, known as unique serialisation. Using one of a number of technologies, including RFID, 1D or 2D barcodes, items are scanned as they are dispensed.
Allowing the pharmacist to check expiry dates and recall information, and provide updated patient care advice, the system ensures pharmacists receive product safety information more rapidly added Aegate. Currently, communications are achieved by fax or post and can reach pharmacies after drugs have been dispensed. The system also allows the authentication of the origins of medicines, thereby protecting against stolen and fake drugs.
PAN-EUROPEAN COVERAGE
With patient safety becoming an increasingly important issue and counterfeit drug sales forecast to hit USD 75 billion by 2010, Professor Simoens concluded: "The full impact of authentication processes will only be realised if such systems are applied fully within and across countries. We believe policy makers on a European and global scale should consider these findings and enact the necessary legislation to introduce drug authentication processes based on mass serialisation technology in community pharmacies."
Aegate has commenced roll-out in a new country every eight months since the technology completed development in 2006 and the next country will be announced shortly Aegate said. Currently in operation in Belgium, Greece and Italy, the system has so far this year scanned more than 24.5 million packs of drugs across Europe according to Aegate.
Urging others to follow the role of Belgium and Greece, Gary Noon, CEO of Aegate, said: "Industry and Governmental organisations now need to step up and demonstrate a similar level of commitment to patient safety."
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