The creation of the of the Falsified Medicines Directive which comprises a number of important patient safety initiatives can be regarded as one of the most significant developments within the pharmaceutical supply change.
This Directive introduces harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.
Measures include:
- Obligatory safety features – a unique identifier and an anti-tampering device – on the outer packaging of medicines
- A common, EU-wide logo to identify legal online pharmacies
- Tougher rules on import of active pharmaceutical ingredients
- Strengthened record-keeping requirements for wholesale distributors.
To enable this Directive to happen it requires all of the key actors in the supply to work together. These actors are:
- Manufacturers
- Wholesalers/distributors
- Parallel Distributors
- Pharmacists
This collaboration between the four parties has been highly successful and the creation of the umbrella organisation namely EMVO, to coordinate and oversee this highly complex initiative is clear evidence of the cooperation and teamwork demonstrated by all parties.
In 2007 some 11 years ago now, the EAASM published a compelling report authored by Dr Jonathan Harper ‘European Patient Safety and Parallel Pharmaceutical Trade – a potential public health disaster?’. Since then all aspects of parallel trade and its governance has seen significant advancements. However, at the time the report helped greatly to support the need for tighter supply chain controls and was therefore influential in the evidence that was considered for the creation of the FMD. To read the report Click here for part 1 and click here for part 2.