EFPIA: mobilising stakeholders on EU falsified medicines directive

Pharmaceutical trade organisation EFPIA has joined forces with bodies representing pharmacists and wholesalers to try to help steer the implementation of the falsified medicines directive in Europe.

Alex Staes of Johnson & Johnson told the recent Pharmaceutical Track and Trace and Authentication virtual conference that EFPIA is in the process of drawing up a memorandum of understanding with peer organisation representing Europe's pharmacists (PGEU) and wholesalers (GIRP) to support the implementation of the directive.

The aim is to bring other trade bodies on board in the coming months, notably those representing Europe's generics sector (EGA), over-the-counter medicines (AESGP), hospital pharmacists (HOPE) and parallel importers (EAEPC).

The MoU is concentrating on the elements of the Directive which concern the addition of safety features to medicine packs, the detail of which is intended to be laid out via the EU's delegated acts process (see End of the beginning' for EU Falsified Medicines Directive). 

The legislation was adopted by the European Parliament in February and mandates the use of safety features (tamper-evident packaging and likely serialisation) for prescription-only medicines and some high-risk over-the-counter drug products, alongside other measures such as tougher criminal sanctions, measures to tackle the Internet trade in fake medicines and various regulatory tools.

"All stakeholders are going to have to work in partnership if we are going to secure the patient safety objectives," Staes told the meeting.

A draft joint position paper has already been established between EFPIA, PGEU and GIRP, thanks to three meetings held since April 2011 to look for common ground. That has resulted in the creation of a list of 10 core principles, which are currently being assessed by the other proposed partners. The list runs as follows:

1.    Tamper evidence with unique serial number;

2.    Continuity of protection throughout the supply chain e.g. with repackers adding their own serial number;

3.    A single pack coding/identification system across Europe (ideally a 2d barcode carrying serial number, expiration date and batch number);

4.    Ensuring product verification database systems can work together across the EU, in other words making sure national systems are interoperable;

5.    Verifying each pack at the pharmacy level, for example using standard procedures for events such as verification failure etc;

6.    Maximising the benefits of mass serialisation, including not only detection of falsified medicines but also expired medicines, recalled drugs etc;

7.    Focus on securing patient safety and protecting patient privacy. EFPIA and its partners believe that manufacturers should have no access to pharmacy and individual prescription data;

8.    Safety features that are simple, robust and cost effective;

9.    Working together in the interests of patients; and

10.    Involving other stakeholders

At the heart of the proposals is the formation of a not-for-profit stakeholder organisation, provisionally called the European Medicines Verification Organisation (EMVO) that would promote the development of a cost-effective and scalable product verification system and propose systems management and governance structure for the verification system.

Staes told the meeting that the expected timeline for implementation of the directive at the moment is 2016/17 for all countries without existing measures, noting that some countries may deploy earlier. The deadline for transposition of the main Directive points into EU member state law is due late 2012/early 2013, with the delegated acts process coming towards the end of 2013 or early 2014.

He reiterated the position that there is no support for a full track-and-trace model at EFPIA at the moment, as the end-to-end model proposed - with codes added to a pack at production and read at the point of dispensing in the pharmacy - "secures all entry and exit points of a country's supply chain." He pointed out that the feasibility of this approach was demonstrated in EFPIA's own pilot in Sweden (see EFPIA publishes serialisation pilot report).

"We believe this is enough to achieve the objective patient safety," said Staes, adding that including full track-and-trace or pedigree elements would add to the cost and complexity and would not enhance this objective. However, he stressed it is important not to try to second guess whether this model will be endorsed by the Commission.

Staes also noted that a pan-European model adds complexity over a national system, as it requires some form of EU central hub to receive and handle data from manufacturers (coding uploads), pharmacies (point-of-dispense verifications), repackers (verification data and new coding uploads) and to a lesser extent wholesalers (checking in cases of suspected packs), for example, whilst also interfacing with existing national systems.