Sept2015 BoardMeeting Agenda Item 13c – Medicines Shortages

Related to September 2015 Board Meeting Agenda item 13c.

An update since last meeting

Joint supply chain stakeholder paper on medicines shortages information

Over the summer, the draft joint position paper of EFPIA, EGA, AESGP, GIRP, EAEPC, PGEU, EAHP, and now EIPG, has continued to develop. Most recently circulated version, with RP comments here. 

A teleconference of the groups participating in the project was held on Thursday 24th September. RP will give a verbal update on the key emerging points at the September Board Meeting. However these include:

• EFPIA and EGA want to discuss using the EMVO system to provide information to national competent authorities on medicines shortages. In theory the EMVO tells us how many packets of each medicine are being produced, at what times and what locations, and where they end up at what times. This could unveil a much better picture on shortages issues (e.g. Whether enough medicine is being produced, extent of parallel trade etc). EFPIA said they are already being approached by Governments on this, and want to give a considered answer. They recognise the request from Governments is legitimate. Richard Bergstrom seems interested in this, and generally seems in favour of exploiting more benefits from EMVO than just anti-counterfeit. The Board are asked to consider if they would support this proposal. 
• Overall EFPIA are pushing for more long term substance and concrete proposals in the paper, and are concerned that the final product not just be another statement of nice words.
• Differences of opinion within the group continue to exist in respect of patient/public involvement, access and interaction with medicines shortages information systems, and on the question of definition of shortages. EAHP has continued to advocate open information systems for medicines shortages in line with those existing in the Netherlands, USA and elsewhere, and for patient group involvement more generally in the joint stakeholder initiative. EFPIA do not like the concept of patients reporting a shortage, fearing it would turn in to a “patient complaint system”. I do not think this is supported by evidence from systems where the public can report (e.g. Netherlands, USA). However, it may not be our biggest sticking point for the document (see definition discussion below).
• Differences of opinion also exist within the group on the question of medicines shortage definition. Both EFPIA and EGA want a more restricted definition than that currently provided for in the paper (” we define a medicine shortage as “an inability of a community or hospital pharmacy, as a result of factors beyond their control, to supply a medicinal product to a patient within 72 hours”). EFPIA want a definition more focused on harm to patient. EGA want a definition that excludes situations where other medicines with the same active ingredient are still available. EAHP’s suggestion of taking this through a Delphi consultation, including patient organisations and potentially other healthcare professionals, has not been taken up. Coordination with PGEU on our position on definitions ahead of the 14th October may therefore be advisable.
• PGEU will be sending 10 representatives to the next ‘Summit’ meeting of the organisations at EFPIA offices in Brussels on 14th October. Darragh O’Loughlin, President of PGEU, will chair the meeting.
• The European Industrial Pharmacists Group are now involved in the initiative, a favourable development in many ways in respect of the principal European pharmacy groups working together on issues of joint interest

RP and JP will represent EAHP at the meeting in Brussels on Wednesday 14th October.

For further reference see written comments from:

• EAHP here. 
• EFPIA here and here
• EGA here (see in particular their suggested visual insertions)
• EIPG here
• GIRP here

Advocacy to EU Council Presidencies

On 15th July, Member States representatives (in the context of the meeting of the Working Party on Public Health at Senior Level) agreed to a long term agenda for better access to innovative and affordable medicines (2015- 2017). As a follow-up to Council Conclusions (December 2014) on Innovation for the Benefit of Patients, the EU Presidency delegations (Luxembourg, Netherlands, Malta, and Slovakia, alongside Belgium) prepared a short paper outlining their priorities and an accompanying roadmap. Amongst many other points, this paper also included reference to the need for Member States to cooperate more fully in the monitoring of medicines shortages.

More information here.

Exchanges with the upcoming Dutch Presidency of the EU Council have sadly not yielded a one-to-one meeting with relevant individuals due to an apparent embargo placed on such meetings. Conversations on the shortages topic are hoped for via other means however. Exchange of emails here.

Attention in any case should now be given to the Slovakian Presidency from July 2016.

Representations to the EMA

The European Medicines Agency is hosting a workshop on medicines shortages on Friday 9th October 2015 at which EAHP has been invited to present. Aida Batista, who attended the previous workshop in 2013, will present for EAHP. RP will also attend. More information here.

The draft agenda for this meeting has now been made available. It is notable that the time for patients and healthcare professionals to present is quite limited (20 minutes). If well conducted, it has the promise to be a good exchange between industry, competent authorities, EMA and other stakeholders, hopefully driven towards some outcomes and actions.

Representations to the European Parliament and elsewhere

RP presented to a European Parliament S&D Group workshop on 1st July on the topic of access to medicines to give reflection on the ‘availability’ aspect of the access question, sharing results of EAHP research and suggested improvements to the EU legal framework that could remedy some of the evident problems. A report from the S&D Group following this workshop is awaited. Presentation given here.

The European Cancer Patient Coalition (ECPC) has also picked up on EAHP’s medicines shortage work, including reference to it within a newly submitted Written Declaration in the European Parliament, and a soon to be published document entitled “a Europe of Disparities” (subsequently amended by EAHP to provide a fuller description of shortages causes).

The European Heart Network (EHN), a patient’s organisation, has invited EAHP to present to its members at a seminar in Brussels on 21 October. Unfortunately this clashes with the GS1 Healthcare conference in Budapest at which RP is facilitating a session on bedside scanning. To discuss alternative representation. 

EAHP has started work with EGA on a joint reflection paper that will include points on medicines shortages in the generics sector and how these might be addressed. See background paper for agenda item 13e on medicines barcoding for more information.

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