European Alliance for Access to Safe Medicines

The EAASM is an active member of the Alliance for Safe Online Pharmacy in the EU (ASOP EU) Community Interest Company (www.asop.eu). As such, it contributes to the development of this not for profit collaborative group. (Participants in ASOP EU are united by a single mission that together they can create an environment that enables patients to buy their medicines online safely, in countries where it is legal for them to do so). The EAASM is also a civil Society member of the EUIPO/Observatory and is an expert with the Expert group of "Search engines". The EAASM is also a National Association of Boards of Pharmacy - DotPharmacy Executive Board Member. It is an active member of the EU Health Coalition as well as having multiple connections to patient safety organisations due it being the secretariat of the ECAMET Alliance and the Nanomedicines Regulatory Coalition.

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Does not represent commercial interests

Jan 2023 - Dec 2023

Since 20 September 2021 self-declared 'non-commercial organisations' are no longer required to provide a lobby budget. See above timeline for this registrant's historical lobby budget.

20,663€

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None declared

none

Artificial intelligence and digital#Cancer
Participated in ESNO and PACT meetings and Health First Europe meetings. Also Civil Society member of The Observatory (EUIPO).

The EAASM is actively involved with the EU Parliament and attends relevant meetings and hosts Healthcare debates in the Parliament bringing together MEPs, Commission and the Council.

The EAASM has been active and successful in calling for amendments to the draft European Parliament Own-initiative Report: "Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance". The EAASM recalls that the EU pharmaceutical legislation was put in place to protect patient safety.

The EAASM was active in contributing to DG SANTE scoping study on off label usage of medicines. The EAASM strongly believes that the Member States' medical professionals inform patients when a medicine is used off-label; and to provide patients with information on the potential risks in order to enable them to give fully informed consent. The EAASM supports the GOLUP approach relating to the process by which off label usage of medicines is decided.

The EAASM recalls that the Internet is the largest unregulated pharmaceutical market place in the world with 62% of medicines purchased online being falsified or substandard with 95.6% of online pharmacies researched operating illegally. The EAASM calls on the European Commission and the Member States to build on the introduction of the Common Logo for online pharmacies (Implementing Regulation No 699/2014) and to extend it to a Europe-wide protocol for licensing online pharmacies which could potentially align with the pre-qualifications of the .pharmacy domain suffix which is well governed by the National Association of Boards of Pharmacy.

The EAASM also supports the objectives and recommendations for the Pharmaceutical Strategy for Europe with the EU Healthcare Coalition which it is a partner. It has also contributed to the EU Commission Structural Dialogue initiative on product shortages.

It has published a number of reports and communications which can be found on the ECAMET Alliance website (https://ecamet.eu) and the Nanomedicines Regulatory Coalition website (https://eunanomedicinescoalition.eu)

1. The Google AdWord grant was extended for another year in November 2017. It has however now ceased. Whilst it was running though in 5 major UE Member States, would be buyers of medicines are drawn to the educational pages via this Google AdWord grant. Over 35,000 first page impressions were being achieved with a >3% click through rate - this is giving rise to over 1000 visitors per day. Integrated in to the web site is an opportunity to complete a survey. Over 2300 responses have now been received and one of the key questions asked is about a willingness to change behaviour. Overwhelming positive results were revealed with 91% saying they would find an authentic website or revert to their local pharmacy.

2. The EAASM has entered into a campaign centred around patient safety and intends to heighten awareness of issues relating to safety aspects of unlicensed and off label medicines, adverse event reporting, patient consent and general increased awareness around this topic.
3. New patient safety projects to do with building a more robust regulatory framework for nanomedicines and two EU Parliament meetings brought about productive discussion and ways forward. The report on the Q3 meeting can be found here https://eaasm.eu/en-gb/2020/11/30/innovation-in-nanomedicines-enhancing-patient-safety-through-regulatory-clarity/ In addition a comprehensive report was produced with a clear call to action https://eaasm.eu/wp-content/uploads/Patient-Safety-and-Nanomedicines-September-2020.pdf
4. A compounding survey is currently being completed by hospital and community pharmacists with a view to sharing best practice to enhance patient safety in this area.
5. The EAASM recently hosted a sharing best practice meeting on the issues around implementing the safety features within the hospital arena and the report can be found here https://eaasm.eu/new-report-demonstrates-significant-resources-requ. A follow up round table took place in September 2020 and a report entitled ‘Patient Safety and the Implementation of the Falsified Medicines Directive in the Hospital Environment: Practical solutions and benefits’. https://eaasm.eu/en-gb/2021/04/07/press-release-new-report-clearly-demonstrates-that-implementing-the-falsified-medicines-directive-in-hospitals-brings-about-massive-positive-change/
5. The Executive Director and Secretariat are also very active in presenting at all types of conferences to promulgate the patient safety activities of the EAASM. He spoke at the EAHP 2017 Congress on falsified medicines and the effect of raise awareness amongst the public and thus tackling the demand side to the equation. He has recently published a paper entitled "What’s in a word? Falsified/counterfeit/fake medicines – the definitions debate" which can be found here http://medicine-access.pointofcarejournals.com/article/852e3095-abed-45dd-bc5b-8c0b6cc8d9e2. In addition a report on the status of Member State progress in terms of awareness raising activity has been published which can be found here https://buysaferx.pharmacy/fake-medicines-continue-to-threaten-consumers/. A detailed report entitled Patient Safety and Nanomedicines - the need for a centralised regulatory procedure will be published by end April 2020. In addition a briefing document is available now so that all areas can understand the complex patient safety issues connected with robust regulatory procedures and analysis. Similarly the European Medication Error and Traceability patient safety project is now well under way with the establishment of a Scientific Committee and a website nearing completion.

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The list below only covers meetings held since November 2014 with commissioners, their cabinet members or directors-general at the European Commission; other lobby meetings with lower-level staff may have taken place, but the European Commission doesn't proactively publish information about these meetings. For more information about which commissioner is responsible for which portfolio, check out this link: https://commissioners.ec.europa.eu/index_en All information below comes from European Commission web pages.

• Date	30 May 2022	Location	Webex
  Subject	Nano-medicines and EU regulatory Framework.
  Cabinet	Cabinet of Commissioner Stella Kyriakides
  Portfolio	Health
  Attending	Karolina Herbout-Borczak (Cabinet member)