September Board agenda item 14e. Barcoding, devices, eHealth and mHealth

 

Over the summer, EAHP has been working with GS1, and hospital pharmacists with special interest in this topic, on finessing the text of a letter to be sent to Pharmaceutical CEOs on the single unit barcoding request. Most recent version here.

 

The background to the campaign includes:

• the unfulfilled promise of EFPIA to formally work together on the issue;
• the advice from several individuals within the pharmaceutical packaging industry that, whilst those responsible for packaging would like to make progress on the issue, the resistance, on cost grounds, comes from higher up within pharmaceutical companies. Buy-in at the CEO level is therefore required.

 

Unresolved questions about the proposed campaign for the moment include:

• Whether to target only EFPIA/originator companies, or to include generic companies (GS1 suggest only originator companies)
• Whether some kind of reciprocal commitment to the process from EAHP should/can be made (GS1’s suggestion)
• Whether more is needed to address the “What’s In It For Me?” question, from the CEO perspective
• Whether the letter is solely from EAHP, or we seek to amass an ad-hoc coalition

In the meantime new EPSA-Intern Raluca Radu is assisting the PAO in developing the database of Pharmaceutical CEO contacts, likely to be the most time-consuming part of the exercise – though with future value in other policy areas. e.g. example.

Potentially to also discuss whether campaign should be email only, or by posted letter with enclosed materials. The latter obviously involves greater expense and time, but would be more formal, with brochure/leaflet helping to provide the additional detail.

In terms of timing, within the EAHP secretariat October 2016 needs to be a month focused on CTF consultation recruitment activity, to which the barcoding letter writing campaign may need to take secondary priority.

Therefore, potentially Andras’s participation at the Pharmaceutical Packaging and Labelling Conference in Vienna, 24th-25th November, could be a suitable occassion to launch/announce the campaign. This need not consist of much more than referencing the campaign within his presentation, and an issued press release. It would however serve the purpose of drawing attention of a key audience group to the activity, provide a favourable talking point during the conference, as well as establishing a firm deadline for the campaign.

 

An EAHP led event on hospital procurement of medicines

 

A sticking point in developing this idea was the form in which any such collaboration would take place, especially its transparency and openness to all relevant interests to participate. Concerns were expressed that a) EAHP not be seen to be engaged in any preferential relationship with one side of industry against another, and b) from the hospital procurement perspective, procurement is procurement and does not overly differentiate in issues between originator and generic. Meanwhile, Medicines for Europe were concerned that introducing originator companies into a discussion (e.g. workshop event) could result in well-rehearsed arguments playing between the two interest groups, to the detriment of forming conclusions.

 

A new way past this logjam is proposed in so far as suggesting EAHP take sole ownership and leadership of a workshop event on procurement, starting from the first principles of Statement implementation i.e. Statement 2.1. “Hospital pharmacists should be involved in the complex process of procurement of medicines. They should ensure transparent procurement processes are in place in line with best practice and national legislation, and based on the principles of safety, quality and efficacy of medicines.”

 

Such a day long workshop event would invite ALL relevant stakeholders (hospital pharmacists, originator industry, generic industry, wholesalers, hospital management, other healthcare professionals, patients) to discuss such matters as:

• obstacles hospital pharmacists may be facing in leveraging their expertise and knowledge into hospital procurement (with potential reference to Survey results on statement 2.1) and how these should be overcome
• what constitutes transparency in medicines procurement, from all stakeholders’ perspectives
• what constitutes best practice in procurement (where issues of value, single unit barcoding, product form, sustainability etc can be introduced)

The main purposes of such an event would be to:

• seek consensus between stakeholders on what medicines procurement systems for hospital should look like, and the ideal role of the hospital pharmacist within this
• draw attention for the need for value and other factors beyond cost to be core parts of procurement, including single unit barcoding and sustainability of supply
• assist thinking of the Statement Implementation team and its ambassadors on the challenges to achieving this statement and how they can be overcome
• to draw out on paper forms of commitment and acknowledgement from industry and other stakeholders, on the value presented by single unit barcoding

Secondary objectives include general marketing and awareness raising of the European Statements and single unit barcoding issues.

The Board is therefore asked for its opinion on this suggested event, and if proceeding, when might be possible to conduct such an event.

 

Other developments on single unit barcoding

 

 

Medical Devices

 

Agreement between Council and Parliament on the text of a new Medical Devices Regulation was reached in June 2016. More information about the agreement here.

The Council is expected to formally approve the new Regulation at Ministerial level soon, with adoption by the European Parliament towards the end of 2016.

Key elements of the regulation include:

• A system of Unique Device Identification to improve traceability;
• Enhanced oversight arrangements for the notified bodies that undertake device assessment;
• Strengthening of clinical data requirements related to medical devices; and,
• Increased transparency in respect to the EUDAMED database.

 

 

mHealth and eHealth

The Board meeting provides an opportunity for update on recent activities in the area of eHealth and mHealth.

Rob Moss continues to represent the hospital pharmacy interest within the European Commission’s mHealth assessment guidelines working group. 

EAHP responded to the consultation of the group over the summer, supporting the more rigorous suggested approach to mHealth assessment. Response here.