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Is the fundamental purpose of providing a Certificate of Pharmaceutical Product (CPP) to assist worldwide patient access to novel medicines still true today?
Background
The WHO Certification Scheme for Certificates of Pharmaceutical Products (CPP) is an international voluntary agreement to provide assurance to countries participating in the Scheme about the quality of pharmaceutical products moving in international commerce.
The Scheme was originally endorsed in 1969 as a powerful instrument to assist national regulatory authorities in sharing information and avoiding duplication. This key principle still holds true.
However, since 1997 the Scheme has not changed despite dramatic changes in the regulatory environment within both the issuing and recipient CPP markets. In this article we examine the Scheme as it is used today and ask: is it time for change?
The CPP Network of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has been collecting experience of how the Scheme operates and influences patient access to medicines. The key observations and recommendations of the Network are described in this article.
Not all accredited authorities meet the requirements or template stated in the guidelines for the Scheme when CPPs are issued.
More than 130 countries are member states of the Scheme or acknowledge and accept the Scheme. However, not all the authorities meet the requirements or adhere to the WHO template guidelines. This is problematic and often leads to confusion within the recipient countries when the requirements and template vary dependent on the issuing health authority (HA). This can be avoided if the template guidance is adhered to. To address this issue, we recommend that all issuing HAs use the WHO template, which will also lead to improvements in legalization requests. When the guidance is followed, many recipient HAs do not request additional certification of the CPP.
The way to apply for a CPP is not harmonized, with each certifying authority having its own system.
There are a variety of systems and procedures across issuing countries on how to apply for a CPP. In order to achieve more transparency of these processes and lead times, it would be helpful to work towards regional harmonization and a standard electronic submission. Harmonization of CPP applications and of payment approaches or methods should be realistic goals resulting in consistent timelines...