Paris, France (PRWEB) March 21, 2005
Participants at the Second Global Forum on Pharmaceutical Anticounterfeiting in Paris demand increased cooperation at all levels and a framework convention to fight counterfeiting of medicines. Combating counterfeit drugs requires the involvement of all parties in the healthcare and pharmaceutical delivery system, placing the onus on manufacturers, all supply chain stakeholders, patients and health professionals as well as regulators and law enforcement to mobilise against fake medicines. Counterfeit drugs penetrate health systems throughout the world, both in industrialised and in developing countries.
Dr Lembit RÃ¤go of the World Health Organization and Dr Dora Akunyili, Director General of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), called for an international framework convention to establish minimum standards and to harmonise international regulations to facilitate the fight against counterfeits. ÂSuch a framework would enable regulation, demonstrate political commitment and will to establish policy and regulation to address the problem, put into place criminal law and sanctions and facilitate cooperation between different law enforcement agencies,Â states the WHO official.
The problem is compounded in Europe, where free trade in pharmaceutical products exists. Governments can and do set different pricing, leading to hugely divergent prices between countries such as Greece and Sweden. This encourages parallel imports, which in turn allows counterfeit products to be introduced. Julian Mount, Senior Director European Trade, Pfizer Inc. said Âthere is a need for stakeholder accountability, uniform systems and regulation leading to accountable supply chain management by all players delivering medicines to patients in Europe. This means pan-European legislation, regulatory coordination, appropriate technologies and the need to better enforce the repackaging of medicines to ensure patient safety and medicine integrity.Â The same could apply to other regions of the world, notably Africa, according to participants from Nigeria and Ghana.
With increasing access to potentially lethal medicines at cheap prices over the internet, Jim Thomson, CEO of the Centre for Mental Health in the UK, warned of the Âloaded gunÂ that fake drugs represent. ÂPotent substances are freely available on the internet and can be ordered easily without any prescription and any authentication of sources, making the public vulnerable to health hazards and public health vulnerable to growing antimicrobial and drug resistance. Because technology has advanced so quickly, it is possible to imagine a diagnostic kit that is sold or preferably supplied at the manufacturerÂs expense with a prescription drug so that patients can test the drug for authenticity before they take it.Â
ÂAs long as the fight against counterfeits is not a concerted effort, criminals will be able to exploit the loopholes in the system,Â says Ian Lancaster, Director of Reconnaissance International, specialists in anti-counterfeiting strategies and organisers of the Global Forum. ÂThe fight includes prevention measures by manufacturers, communication and effective education of professionals and patients, and ensuring that punishments are appropriate to this deadly crime.Â
The Global Forum is the only congress in the world that brings together all the stakeholders from developing and industrialised countries. Attendees at the Forum included government regulatory authorities, pharmaceutical companies, patient groups, health professional groups and other stakeholders in the fight against counterfeit medicines. Forum organiser Reconnaissance International is the internationally-known publisher of Authentication NewsÂ, which covers the issues, strategies and technologies of anti-counterfeiting and diversion, and is also the publisher of Medicines & Pharmaceuticals: A Manual of AntiCounterfeiting Solutions. It has reported on the problems of pharmaceutical counterfeiting for more than seven years and has organised a series of successful Pharmaceutical AntiCounterfeiting Solutions Executive Briefings in both the US and Europe, including the first Global Forum on Pharmaceutical AntiCounterfeiting, held with the participation of the WHO, in Geneva in 2002.
Reconnaissance International is planning the next Global Forum for 2007.
NOTE TO EDITORS:
According to the World Health OrganizationÂs definition a counterfeit medicine Âis one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packagingÂ. It is estimated that one in 20 pharmaceutical products on the market is counterfeit, with the number rising to one in three in some developing countries.
Counterfeit pharmaceuticals are manufactured and distributed by criminals, companies or individuals who have the desire to make money unlawfully. They may contain too much, too little or no active ingredient, the wrong ingredients or high levels of impurities, contaminants and even toxic substances. They could be reject or out-of-date formulations withdrawn from the market which are obtained by counterfeiters, relabelled as bona fide product and introduced back into circulation. They have killed and injured thousands around the world.
The consequences of such counterfeits can vary. They can either fail to treat the illness or condition for which they are being taken (resulting in prolonged illness or death and wastage of valuable healthcare resources) or they can be the direct cause of death by containing lethal ingredients. Whether they fail to promote or restore health, or are the direct cause of death, they are fast becoming a global menace Â both to their unwitting consumers and to the pharmaceutical industry as a whole.
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