OPERATION VOLCANO: THE HERCEPTIN CASE
Story, lesson learned, proposals
AIFA, AEMPS, AGES, IGZ, MHRA (2016)
The so-called “Operation Volcano”, also known as “Herceptin case”, originates upon receipt of an alert by a German parallel distributor, soon followed by further investigations in respect of which emerged that vials of the cancer medicine Herceptin (trastuzumab), stolen from Italian hospitals, have been manipulated and falsified and re-introduced under false credentials by unauthorized wholesalers into the legal supply chain. Upon further investigation by the Italian authorities, additional medicinal products have been identified as stolen in Italy and, subsequently, re-introduced under false credentials by a criminal organization connected to Italy, by following a similar scheme. By explaining the case in detail, summarising the key lessons learned and the possible preventive actions, this White Paper calls for a stronger enforcement effort against pharmacrime, with more resources at MS level and an ad hoc coordination at EU level.
Pharmaceutical Crime is a major public health concern which jeopardises human lives and causes direct damage to patients and to the pharmaceutical supply chain - consisting of manufacturers, distributors, pharmacists, doctors, private organisations and public bodies. The international organisations combating pharmaceutical crimes have long considered such problem as one of the most serious emergencies to be tackled. However, current applicable legislation is still not sufficient to efficiently counter the criminal activities carried out by individuals or international criminal organisations; full implementation of the Medicrime Convention of the Council of Europe (signed by Italy in October 2011, and presently in the process of ratification), could allow to adopt appropriate measures as well as deterrent sanctions, proportional to the gravity of the criminal behaviours. It is likewise necessary to improve the existing rules through fostering international cooperation between health authorities and the judiciary for a timely identification of offences and related criminal penalties, in order to appropriately prosecute criminals.