'End of the beginning' for EU Falsified Medicines Directive

Now that the dust has settled on the European Parliament's approval of the Directive on Falsified Medicines - and the May 27 ratification by the Council of the European Union - attention is turning to the tricky process of implementing the measures within it.

The Directive requires a rather different approach to implementation than the EU's traditional 'comitology' procedure, in which committees of member state experts were given the task of overseeing transposition.

Since 2009's Lisbon Treaty, the traditional comitology approach - known as regulatory procedure with scrutiny -  has been replaced by a 'delegated acts' process for new laws proposed after the new Treaty's entry into force. While similar on the face of it, there are some key differences which have an impact on the way stakeholders get involved to lobby and influence the end result.

This delegated acts approach is so new that, to date, not a single delegated act has been adopted, although many pieces of legislation are going through the process at the moment.

How does the new procedure work?

SecuringPharma.com spoke with Andras Baneth, a former European Commission official who now runs training courses on the post-Lisbon regulatory procedures, to get an explanation of the new process.

The key element of the new process is the introduction of a secondary legislation process - deferred to the European Commission - used to draw up 'delegated acts' and 'implementing measures'. 

A delegated act should be a measure that "amends or supplements non-essential elements" of the basic act, such as annexes. In contrast, an implementing measure gives the detail required to allow essential "individual" elements of the basic act to be carried out, such as market authorisations.

Giving an example, Baneth noted that the medicinal products for human use directive's latest 2010 amendment provides good examples of both delegated acts and implementing measures. The list of situations when post-authorisation efficacy studies are required would be decided by a delegated act, but issues related to pharmacovigilance would be processed by the implementing measure process.

A key change from the traditional comitology process in the case of delegated acts is that the Commission no longer has a legal requirement to consult with member states, industry or other external stakeholders while drawing up delegated acts, although it clearly retains a political imperative to do so, according to Baneth.

Under the old system this process was overseen and scrutinised by a member state committee.

"Once the Commission has passed a delegated act, it is no longer a draft - the only option open to Parliament or the Council if one of them is dissatisfied with the outcome is to veto it," according to Baneth. However, the deadline for a veto is relatively short - two to four months in principle - and Parliament must win an absolute majority to do so.

For implementing measures - which generally cover the detailed technical and practical requirements which are alluded to but not spelled out in the overarching Directive - the change to the system is less marked. The Commission prepares a proposal which is put to a member state committee for review. These meetings are now chaired by the Commission both at first instance and in the so-called "appeal committee", whereas in case of disagreement, they were chaired by a representative of the current rotating EU presidency under the old system.

However, if the committee does not agree with the Commission's proposal it no longer goes in front of the EU Council of Ministers for political discussion, as was the case with the old comitology system. That means there is no longer an avenue for member state ministers to introduce amendments to the dossier in case the Commission holds a different position.

Voting works much as before but in cases of "no opinion" - where member states are divided and cannot reach qualified majority - the Commission can decide to adopt a measure if it chooses to.

"This leaves a lot of power in the hands of the Commission," said Baneth.

Why was it introduced?

The new delegated acts process was drawn up in the wake of controversy over the implementation of genetically-modified corn legislation a few years ago. It has been alleged that the comitology procedure was exploited to allow the European Commission to allow GM corn to be grown in the EU, despite opposition from a majority of EU countries.

The consequences of this new process are that the European Commission can now decide delegated acts and implementing measures with greater independence but is also subject to greater political pressure to ensure that the core premises outlined in the Parliament and Council-approved Directive are retained.

"The Delegated Acts process was introduced to speed directives into legislation," commented Jim Thomson of the European Alliance for Access to Safe Medicines (EAASM), at last month's Global Forum on Pharmaceutical Anti-Counterfeiting conference in London, UK.

"Delegated acts are specifically not designed to add or take away from the legislative process," he added. In other words, they cannot add into legislation anything that was not deemed "essential" in an approved Directive, neither can they remove anything that was deemed essential.

There is however no clear definition or case law on what can be considered as "essential" elements, which leaves room for different interpretations by the industry and the regulator.

How does it specifically affect the Falsified Medicines Directive?

The Falsified Medicines Directive will make use of both delegated acts and implementing measure procedures. To recap, the key elements of the Directive are as follows:

• Introduction of safety features for medicine packs, expected to be serial numbers and tamper-evident seals;
• Product traceability through the supply chain;
• More stringent rules for the importation of active pharmaceutical ingredients (APIs), plus control and inspections of EU plants manufacturing APIs;
• Extended control over the API and medicines supply chain, including improved scrutiny of brokers and traders;
• Greater oversight of Internet sales, including official logo for certified online pharmacies;
• More stringent sanctions against counterfeiters.

According to the adopted text, "the measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred by the Commission."

"This refers to the implementing measures procedure, according to the 'new' rules that entered into force on 1 March 2011," noted Baneth.

"The essence of this is that the Commission chairs all meetings and prepares/amends its draft, and the 27 member states can propose changes - always subject to the Commission's approval - and vote on it. Though it's quite complex, the essence is that unless they vote against by qualified majority in the committee and in some special cases, again in the appeal committee, the Commission can adopt it."

The issue of safety features, however, comes under the delegated acts procedure as introduced by the Lisbon Treaty.

In this case, as discussed, "the Commission can adopt the measure by itself and the Parliament/Council can only veto it - within up to four months - by absolute majority (EP) or qualified majority (Council) but not amend it in any way," according to Baneth.

What does the new procedure mean for stakeholders?

According to Baneth, the changeover to the delegated acts process means that it is no longer clear how external stakeholders can be involved in the procedure.

"First and foremost, stakeholders need to establish which procedure - delegated act or implementing measure - is foreseen in the Directive for the issues that affect them," according to Baneth.

They should conduct an analysis of whether the process is appropriate and whether the Commission's viewpoint is aligned with their own position. "If the industry's wishes are in accordance with the Commission's viewpoint, a delegated act is fine," according to Baneth. "But when an issue requires more scrutiny, implementing measures seem preferable as it allows member state involvement and more channels for advocacy."

It is possible to argue for a change in procedure if strong and supportive legal arguments can be developed, he said. Otherwise, stakeholders should lobby hard to get their viewpoints acknowledged during the proposal and adoption phase of the delegated acts and implementing measures.

"Just remember that the timeframes can be very short, for example as little as a few weeks to two to three months for an implementing measure," cautioned Baneth. Once adopted, the only recourse would be to challenge the measure in the courts and even there mostly on procedural grounds only.

The need for swift action by stakeholders was also emphasised by Jim Thomson at last month's conference.

"This is NOT negotiable. The Delegated Acts process is designed to enable experts to shape the detail of the headline legislation. Now is the time to get involved."