European Association of E-Pharmacies

…1 PAGE April 2023 EAEP feedback to the Public Consultation on the Packaging and Packaging Waste Regulation proposal The European Association of E-Pharmacies (EAEP), as the organisation representing the voice of the e-pharmacy sector on the European continent, welcomes the opportunity to provide feedback on the initiative “Packaging and Packaging Waste Regulation” (PPWR) proposal. We look forward to continuing to engage in this and other policy initiatives stemming from the Green Deal. EAEP members recognise that all stakeholders across the value chain need to take steps to enable the fundamental transformation of our economy, society, and industry.

…the value chain need to take steps to enable the fundamental transformation of our economy, society, and industry. Based on their leading role in innovation and technology, online pharmacies play an important part in ensuring patient access to medications and healthcare services while also improving the overall sustainability of the healthcare product and supply chain. In that sense, we strive to be ambitious in reducing our ecological footprint while at the same timing serving our patients with the quality and care they expect from us.

…our ecological footprint while at the same timing serving our patients with the quality and care they expect from us. As we constantly seek ways to reduce the sector’s ecological footprint across the value chain, we are of the opinion that the new rules governing packaging and packaging waste, and any future legislation, should overall ensure harmonised definitions and standards across the EU – a level playing field, while considering the specifics required for packaging pharmaceutical/medicinal products in each EU Member State. To this end, the EAEP wishes to underline three key pillars, calling on the EU Institutions to: Avoid a one-size-fits-all approach when it comes to provisions for e-commerce operators due to reasons of (public) health protection.

…approach when it comes to provisions for e-commerce operators due to reasons of (public) health protection. • E-pharmacies, as healthcare providers, deal with the delivery of amongst others medicinal products – categories which require measures to ensure that the packaging does not jeopardise the safety of the shipped products. Since patient safety is of utmost importance, the final text of the legislation should not impose packaging limitation if they directly affect the health and wellbeing of European citizens. ▪ Although the packaging used should be as sustainable as possible, the EAEP notes that it is unclear how to handle potential complaints (e-commerce players would be required to e.g. document the empty space ratio of every single parcel). This would lead to excessive administrative burden which should be by all means avoided. Ref.

…of every single parcel). This would lead to excessive administrative burden which should be by all means avoided. Ref. Ares(2023)2835322 - 21/04/2023 2 PAGE PAGE ▪ The proposed 40% ratio should not apply to re-usable packaging (Art. 21), as otherwise e- commerce players would have to make use of many different sizes of re-use packaging in stock, which will hardly be actionable. ▪ It should be clarified that the so-called performance criteria justify an exemption of the 40% empty space ratio (e.g. when the product itself or the handling of a product require certain protection or minimum sizes of the packaging due to health protection reasons). o For example, this is the case for certain medicinal products that need coolers, to be placed within the individual packaging in the transport phase, at certain weather conditions, for the safety requirements of the medicine to be upheld.

…in the transport phase, at certain weather conditions, for the safety requirements of the medicine to be upheld. The volume of these coolers together with void space would in many cases exceed the 40 % empty space ratio. We therefore suggest that elements necessary to ensure product safety are exempted from the 40 % empty space ratio. o Another example are products with small measurements, as it is often the case for drugs and other medicinal products. Shipping service providers have minimum requirements for the size of a parcel in order to be processed, furthermore it also needs to be ensured that the required information (e.g. shipping label) can be provided on the parcel. It should therefore be made clear in the regulation that handling and product safety requirements justify an exemption of the 40% empty space ratio.

…in the regulation that handling and product safety requirements justify an exemption of the 40% empty space ratio. Thoroughly assess the consequences of mandatory standards for the reusability of packaging (B2C) for e-commerce players in the healthcare domain. • The proposal should include a requirement at systemic level to push for the reusability of packaging: offers should be made to carriers in such a way that a sustainable system is set up, e.g. by using a deposit system like is the case in many countries with plastic bottles and increasingly aluminium cans. • Therefore, the 50 % quota of reusable packaging within a system for re-use until 2040, proposed in the PPWR proposal, should only be implemented if a system for re-use would actually reduce carbon footprint, as also the return of the re-use packaging has to be taken into account.

…re-use would actually reduce carbon footprint, as also the return of the re-use packaging has to be taken into account. Furthermore, the customer’s active involvement in such re-use system is an instrumental factor. Put forward standards applicable to all operators (e.g. suppliers, carriers) across the whole supply/value chain, in order to make its implementation possible and consistent. 3 PAGE PAGE To know more about the activities of the EAEP in the sustainability domain, please check at our latest position paper. ABOUT US The European Association of E-Pharmacies (EAEP) represents the interests of e-pharmacies on the European continent. The EAEP voices its interests mainly with political stakeholders, regional and business actors, with the ultimate aim to improve the health of Europe’s citizens and strengthen the European healthcare system.

…with the ultimate aim to improve the health of Europe’s citizens and strengthen the European healthcare system. E-pharmacies have digitalised the classical pharmacy, and therefore act at the crossroads of digitalisation, healthcare, e-commerce and sustainability. As pioneers in providing digital solutions and our innovative and secure processes in dealing with health data, offering medicinal products and digital healthcare service while complying with national and EU law, the EAEP members continuously seek for ways to enhance the quality, safety and efficiency of healthcare for Europeans For more information, please contact: Martino Canonico EAEP Public Affairs Manager [email protected]

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…1 PAGE February 2024 EAEP feedback to the call for evidence – Report on the General Data Protection Regulation The European Association of E-Pharmacies (EAEP), which represents online pharmacies and their patients on the European continent, welcomes the opportunity to provide its feedback on the implementation of the General Data Protection Regulation (GDPR), six years after its implementation. The EAEP strongly believes that the protection of the rights and freedoms of its members’ patients is central with a view to establishing digital trust. Indeed, online pharmacies, as healthcare providers, treat patients’ sensitive data with high standards of protection and diligence. The GDPR plays an important role in creating a unified framework to safeguard these rights of individuals.

…diligence. The GDPR plays an important role in creating a unified framework to safeguard these rights of individuals. With the aim to support patients with their health needs and to improve overall public health, online pharmacies are required to process such sensitive data in a safe, lawful, transparent, and fair manner. In this context, the most significant challenges brought by the GDPR, especially in an international context, stem from the very diverse interpretation of the requirements in the EU Member States, at times even within the same Member State. While some EU countries lean to a pragmatic, innovation- friendly interpretation, others interpret the guidelines in a very restrictive manner, making compliance and implementation complicated, or even unaffordable, for stakeholders. For businesses and innovation to flourish, a harmonised framework is a crucial pillar.

…unaffordable, for stakeholders. For businesses and innovation to flourish, a harmonised framework is a crucial pillar. Especially within the e-commerce domain, slightly diverging interpretations in a court judgement, or local law, can lead to significant operational and financial impacts on organisations. With clear guidelines on implementation and unified rules throughout all Member States, online pharmacies would be enabled to innovate and better fulfil patients’ health needs, ultimately contributing to public health goals. Concrete, pragmatic, and realistic guidelines, harmonised in all Member States, would enable organisations to fulfil their data protection obligations while ensuring the necessary legal certainty to foster innovation. In light of the above, the EAEP wishes to underline the following major concerns:

…legal certainty to foster innovation. In light of the above, the EAEP wishes to underline the following major concerns: 1. Lack of uniform implementation of the GDPR: in each EU Member State, and sometimes even within the same country, one deals with the application of the GDPR in a different, fragmented way. As an example, online pharmacies based in e.g. the Netherlands, but serving patients in Germany, are challenged by the different approaches to health data protection, which in Germany Ref. Ares(2024)974692 - 08/02/2024 2 PAGE PAGE is very strict. In other countries, provisions around health data protection are more pragmatic while still fulfilling the goal of ensuring the highest possible protection of sensitive data. Especially for organisations operating across borders, this represents a major challenge.

…protection of sensitive data. Especially for organisations operating across borders, this represents a major challenge. 2. Concrete implementation guidelines vary greatly depending on the Member State and the European jurisprudence. Harmonised implementation guidelines that are applicable to all Member States would help online businesses enormously.

Harmonised implementation guidelines that are applicable to all Member States would help online businesses enormously. 3. As healthcare providers, online pharmacies play a key role in providing health services, and enabling patients to manage their health, namely their medication. The current fragmented landscape for processing of health data is slowing down the development of new services to better support patients and contribute to public health objectives. ABOUT US The European Association of E-Pharmacies (EAEP) represents the interests of e-pharmacies on the European continent. The EAEP voices its interests mainly with political stakeholders, regional and business actors, with the ultimate aim to improve the health of Europe’s citizens and strengthen the European healthcare system. E-pharmacies have digitalised the classical pharmacy, and therefore act at the crossroads of…

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