Cyprus took over EU Presidency – The role of the EC Rep
The role of the rotating Presidency of the Council of the European Union is, from time to time, not perfectly clear even for a European Member State not even mentioning a non-EU country, to whom it may appear as a function without any effects.
The reality is, however, the contrary. The Presidency’s role and activity during the 6 months can have a significant impact on both EU and non-EU members.
To explain it in nutshell: regardless of the geographical size, or population number, or political situation – thinking about Cyprus – each and every EU Member State is part of the continuously rotating Presidency trio.
The 2011–2012 trio consists of
- Poland (1 July 2011 – 31 December 2011)
- Denmark (1 January 2012 – 30 June 2012)
- Cyprus (1 July 2012 – 31 December 2012).
During the 6 months, the Presidency functions as a chairmen of the meetings of the Council, acts as an ‘ honest broker’, sets and determines the agenda and work programs (evidently, along certain guidelines, however, the Presidency has a so-called 5% maneuver ability in which many national matters are put on the agenda as priority).
Obelis , acting as a European Authorized Representative (EC Rep), takes one of its main responsibilities to gain accurate information on time, provide regulatory consultancy (eg. on CE marking ), follow any regulatory changes and take necessary steps when needed. For this reason, having a new Presidency requires a permanent awareness from Obelis’ experts
To highlight here only the relevant subjects, the Cypriot Presidency may lead to noteworthy amendments in the field of Health polices, which directly or indirectly will need to be taken into account when entering or placing product on the EU market.
The Cyprus Presidency lists 7 priorities for health:
- Healthy ageing across the lifecycle
- legislative proposal on serious cross border threats to health
- Organ donation and transplantation
- Clinical Trials
- Transparency of measures regulating the pricing of medicinal products for human use
- Medical Device regulation
To quote the Presidency’s website in respect of the MDD 93/42/EEC the IVD 98/79/EEC and AIMDD 90/385/EEC they say:
“The three directives on medical devices aim to protect the health, ensure the safety of EU citizens and allow the proper functioning of the single market. The results of a public consultation launched in May 2008 for possible recasting of the medical devices directives, led to the need for a fundamental revision of the existing directives in order to simplify and strengthen the current EU legal framework for medical devices to meet the growing expectations of European citizens. Additionally, the recent incidents with breast implants and large Metal-on-Metal hip replacements, revealed the need for increased coordination between the member states in order to guarantee patient safety. The Cyprus Presidency will initiate the discussions of the new legislative proposals at the Council.”
Even though, EU regulatory changes does not happen from one day to another (but rather takes some years until a new codification) Obelis needs to ensure continuous and precise compliance for its current and potential clients.