Which Role Does the Rx-360 Consortium Play in the Fight against Counterfeit Medicines?

On 3 June 2009, the Rx-360 Consortium was officially registered in the USA as a not-for-profit organisation. The Consortium is part of an initiative supported by the industry with the objective to take the lead in protecting the global supply chain for pharmaceutical products.

With regard to patient safety, managing the pharmaceutical supply chain has become one of the most important issues today. The globalisation of the distribution, both for the medicinal product itself and for the starting materials used, has brought about many difficulties and complications - often with tragic consequences - which still have to be resolved.

Unscrupulous agents and non-compliant firms within the pharm. supply chain have introduced counterfeit and contaminated materials that have caused the death of hundreds, if not thousands, of individuals.

The legislators and those responsible around the world develop and implement local measures in order to curb these activities and to reduce the effects. Rx-360 sees itself as a worldwide consortium that wants to complement these local activities and to set harmonised standards worldwide.

The four key tasks of the Consortium are:

1. the introduction of harmonised standards,
2. the development of new technologies,
3. the monitoring (among others of suspicious suppliers) and
4. joint audits of the suppliers.

The Gold Sheet of June 2009 states that the pharmaceutical industry increasingly supports the idea of joint audits by Rx-360 and that it sees them as an opportunity to save costs and also as an opportunity to better control the growing threat to the global supply chain. Here the pharmaceutical manufacturers are asked to make an active contribution and to help in developing the best approaches and standards.

On the Rx-360 website, concrete targets are defined for the next 3 years. Among them is the training of auditors (for about 1,000 audits) and the creation of additional standards for distribution, storage, import, etc.

The complete objectives can be found here.

You will also get detailed information about RX-360 and its role in the fight against counterfeit medicines at the University of Würzburg's conference "Strategies against Counterfeit Medicines" to be held at the Maritim Hotel in Würzburg, Germany, on 26-28 April 2010.

Amgen's Jean-Michel Guirado will present the new RX-360 approach to a secure supply chain:

  • Which are the weaknesses & un-met needs of the current pharmaceutical supply chain?
  • What are RX-360's plans and concrete tasks?
  • How can a "win-win" situation be achieved for all interested parties?
  • Which standards are required?
  • What are the critical technologies for securing the supply chain?
  • What is the current status of RX-360, and how can one join?

At the conference in Würzburg, you will receive first-hand information so as to be capable of deciding if the active participation in RX-360 is the right step for you and your company in the fight against counterfeit medicines.

You can read the complete programme of the Würzburg conference here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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