Pharmaceuticals

Innovative Medicines

Expensive “innovative” medicinal products pose new challenges to hospital activity, despite the added value of some of these products is not always clear. They influence hospitals financing models and organisation, also potentially leading to treatment rationing, unethical and ineffective from a public health perspective.

HOPE released in January 2017 its position paper Expensive medicines: Hospitals are concerned, calling for greater attention on the consequences that several “innovative” medicines can bring about in hospital activities. It provides an overview of the current situation at European level – welcoming the 17 June 2016 Council conclusions – and calls for further development of Member States driven voluntary cooperation between relevant authorities and payers. Finally, it gives recommendations on possible actions to take at hospital and healthcare services level to address this issue.

In April 2017, HOPE responded to the OECD Online Consultation on “Sustainable access to innovative therapies” and released it position.

Falsified Medicines

In 2011, a Directive was adopted with the aim of preventing the entry into the supply chain of falsified medicines and, since then, the European Commission has been working on a number of implementing measures. HOPE closely followed the EU legislative developments on this issue and replied to a public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use launched by the European Commission in April 2012 and participated to stakeholder workshops organised by the Commission representing the healthcare providers’ perspective.

In February 2016, a Delegated Act was adopted. The delegated act, applicable from February 2019, introduces medicine authentication by means of two safety features: a unique identifier and an anti‐tampering device, which will protect patients from the risks of falsified medicines and the consequences of common dispensing errors. It also provides for an end-to-end verification system to ensure authenticity and integrity of medicine packaging at dispensing points for patients, namely in pharmacies and hospitals.

With a view to facilitating compliance with the Regulation by 2019, HOPE conducted a mapping exercise of hospital representation within the National Medicines Verification Systems (NMVOs) in the Member States in 2016. Moreover, in February 2017 HOPE joined the European Medicines Verification Organisation (EMVO) as Associate Member. The EMVO is the not-for-profit organisation in charge of the medicines verification system management and governance created in February 2015. This collaboration will aim to facilitate a smooth implementation of the Regulation in European hospitals.

Clinical trials

A majority of hospitals are involved in research studies which often take the form of clinical trials. In 2012 the European Commission published a proposal for a revised Regulation on clinical trials. The new legislative text was adopted in April 2014 and will indicatively apply from mid-2016, once the EU portal and EU database for clinical trials will achieve full functionality.

HOPE considers the Regulation to be a significant improvement to the previous Directive 2001/20/EC and a clear attempt to streamline the authorisation of new clinical trials.

Pharmaceutical in the Environment

From 22 November 2017 to 21 February 2018, the European Commission launched a consultation on pharmaceuticals in the environment. This consultation was part of a study gathering views on possible actions to address the risks from pharmaceuticals in the environment to support the development of a European Union (EU) strategic approach in this area. HOPE answered the consultation in February 2018.

EU Projects

PHIS
Pharmaceutical Health Information System