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Doctors Without Borders/Médecins Sans Frontierès (MSF) needs the new and improved version of LPV/r (lopinavir/ritonavir) for its AIDS projects now — the drug is a crucial component of second-line antiretroviral therapy, and is particularly important for use in many developing counties where MSF operates, since it no longer requires refrigeration, as the old version does. Today this heat-stable, fixed-dose combination is only available in the US.

However, Abbott has not begun the process of registering this drug in developing countries and claims that this process cannot begin until the drug is registered in Europe. This document explains why the company does not need to wait but instead could begin filing for registration in developing countries now.

Abbott claims that a Certificate of Pharmaceutical Product (CPP) must be issued from Europe in order to register the new formulation in developing countries. We claim that this is a choice. According to the WHO, the CPP must be issued by the exporting country and therefore could be issued today by the US FDA.

What is a Certificate of Pharmaceutical Product?

The CPP is one part of a multi-pronged strategy to improve national drug authorities' ability to regulate products by creating a standard that clearly communicates a drug's status with respect to marketing authority and manufacturing standards. Essentially the CPP says, "yes we (e.g. the US FDA) have registered this product as safe for sale in our country and we inspect and have confidence in the manufacturing practices of the producer." Not all countries even require a CPP to register a drug for use, but those that do, require it from the exporting country. For instance, Abbott has said it will file for registration of the new LPV/r formulation in South Africa — the only developing country the company has slated for registration so far — where the drug regulatory authority does not require a CPP for registration. Abbott could file for registration in all developing countries, and if a country does require a CPP, it could be issued from the US drug regulatory authorities.

Reading Between the Lines: The facts about the CPP

Abbott says it needs an EU CPP in order to register the drug in African countries, because the new version of LPV/r is manufactured in a plant in Germany. But the key point here is not where the drug is produced, but from which country it will be exported. Abbott may want to export this product from Europe instead of from the US, but this is a commercial decision, NOT a regulatory requirement. New LPV/r was approved by the US FDA in October 2005, and is available only in the US right now. MSF has confirmed that the US FDA inspects the manufacturing plant in Germany where the product is manufactured and has been assured that the FDA could issue a CPP.

The Bottom Line:
As not every country requires a CPP for registration, Abbott should immediately register the drug in those countries that do not require a CPP, and should obtain a US CPP to expedite registration in countries that do.

How will the CPP issue affect MSF's effort to get new LPV/r to its projects?

Because MSF will be trying to obtain special authorization to get new LPV/r to its projects, the CPP question is not relevant right now, as it is a requirement related to registration in some countries. But it is important to understand that Abbott's excuse for its delay in registering this urgently needed formulation in Africa is not based on the WHO or country requirements. If Abbott wanted to facilitate the long-term availability of the new formulation of LPV/r as soon as possible, it could file for registration in those countries that do not require a CPP now and request a CPP from the US in order to file in all remaining countries. (version 28/02/06)