European Federation of Pharmaceutical Industries and Associations

Final INTERNATIONAL DATA TRANSFERS EXECUTIVE SUMMARY  Multinational pharmaceutical companies strive to produce therapies and products that are effective and safe for use around the world. To accomplish this goal, companies must conduct research and monitor the effect of their therapies in geographically diverse populations around the world. This requires the collection and analysis of patient information on a global basis.  European data protection laws restrict the transfer of personal information across national borders. Within the European Union and European Economic Area, data can be transferred freely, but transfers to other regions can only take place subject to a variety of legal restrictions.  Currently, there are mechanisms in place to enable transfers of personal information to countries outside of the EU/EEA.

…there are mechanisms in place to enable transfers of personal information to countries outside of the EU/EEA. However, these mechanisms have been challenged in European courts, raising the spectre that international data flows could be disrupted.  Disruptions to global flows of pharmaceutical data could jeopardise public health. Such international data transfers are vital to the goals of improving patient safety, cultivating public health, and accelerating the availability of innovative therapies.  Pharmaceutical research is already highly regulated and subject to international ethical standards designed to strike a balance between protecting patient privacy and advancing human health. Similarly, the collection and transfer of information concerning possible adverse drug reactions is required by law and subject to legal and ethical frameworks.

…information concerning possible adverse drug reactions is required by law and subject to legal and ethical frameworks.  Data protection authorities should recognise that (i) international transfers of personal information for purposes of medical research and monitoring drug reactions are necessary for important reasons of substantial public interest and (ii) these transfers take place pursuant to legal and ethical frameworks that ensure the confidentiality of the data and protection of individual privacy rights.  European data protection laws contain derogations that enable the flow of data where public interests are at stake and empower data protection authorities to approve such transfers, taking into account the safeguards in place.

…stake and empower data protection authorities to approve such transfers, taking into account the safeguards in place. In the event that current mechanisms for transferring personal information across borders were to be invalidated by European courts, data protection authorities should act swiftly to approve pharmaceutical data transfers pursuant to these derogations, so as to avoid disruption to critical data flows. Ref. Ares(2020)2299202 - 29/04/2020 Final 2 | P a g e BACKGROUND The pharmaceutical industry plays an essential role in the modern global healthcare system. By sponsoring investigatory research and clinical trials, the industry drives innovation and advancement in treatment and disease management. The industry operates on a global scale, and many pharmaceutical companies have evolved into multinational corporations.

…industry operates on a global scale, and many pharmaceutical companies have evolved into multinational corporations. The benefits Restrictions on the Transfer of Personal Data Outside the EU Both the EU Data Protection Directive and the new General Data Protection Regulation (GDPR) that will come into effect in May 2018 restrict transfers of personal data to jurisdictions outside of the European Economic Area (EEA) (i.e., for the purposes of data protection, the area comprised of the 28 EU member states and Iceland, Norway and Liechtenstein) unless the recipient is located in a jurisdiction deemed to provide an adequate level of data protection under its legal system. The European Commission has been given the power to determine whether a third country provides adequate protection.

The European Commission has been given the power to determine whether a third country provides adequate protection. In addition to certain territories, the Commission has so far recognized the following countries as providing adequate protection: Andorra, Argentina, Canada (PIPEDA), Israel, New Zealand, Switzerland, and Uruguay.

…as providing adequate protection: Andorra, Argentina, Canada (PIPEDA), Israel, New Zealand, Switzerland, and Uruguay. The Directive permits transfers to countries that do not provide an adequate level of protection if one or more of the following conditions is met: the data subject has explicitly consented to the transfer; the transfer is necessary for the performance of a contract between the data subject and the organization exporting the data; the transfer is necessary for the performance of a contract concluded in the interest of the data subject; the transfer is necessary in order to protect the vital interests of the data subject; or the transfer is necessary or legally required on important public interest grounds, or for the establishment, exercise, or defence of legal claims. A similar set of conditions exists under the GDPR.

…or for the establishment, exercise, or defence of legal claims. A similar set of conditions exists under the GDPR. The EU data protection authorities have recommended that these exceptions to the general prohibition on cross-border transfers be interpreted narrowly. Finally, the Directive and the GDPR also permit transfers of personal data to jurisdictions outside of the EEA where the data exporter and the data importer have implemented appropriate safeguards that compensate for any lack of equivalent or appropriate data protection in the legal system where the recipient is located (in comparison with the data protection granted in the EU).

…in the legal system where the recipient is located (in comparison with the data protection granted in the EU). Among others, these safeguards can take the form of standard contractual clauses that are executed by the data exporter in the EU and the non-EU recipient, as well as “binding corporate rules” that only apply to intra-group transfers among affiliated entities in a multinational corporation. Pharmaceutical companies make use of many of the above legal mechanisms to transfer personal data. For instance, in the context of data collected in clinical trials, pharmaceutical companies provide participants with a notice that informs them that their data will be sent to jurisdictions outside of the EEA and that these jurisdictions may not have data protection laws that are equivalent to EU data protection laws, and the written, informed consent of each participant is obtained.

…laws that are equivalent to EU data protection laws, and the written, informed consent of each participant is obtained. In addition, many companies have executed standard contractual clauses or adopted binding corporate rules to further demonstrate and augment the protections that are already a standard practice for protecting pharmaceutical research and drug safety information. Further, for companies needing to transfer personal data to the United States, a legal framework agreed between the U.S. Department of Commerce and European Commission called the “Privacy Shield” enables participating U.S. organizations to transfer data. This Privacy Shield contains a specific supplemental principle devoted to “Pharmaceutical and Medical Products”. There are, nevertheless, concerns within the pharmaceutical industry as to the long-term, continued availability of some of these mechanisms.

…concerns within the pharmaceutical industry as to the long-term, continued availability of some of these mechanisms. For example, both the standard contractual clauses and the Privacy Shield are subject to legal challenges in the EU. Moreover, the Article 29 Working Party has suggested that key-coded data is excluded from the scope of the Privacy Shield framework. Final 3 | P a g e of globalization of the drug industry are best exemplified in research and development, which occurs in a complex ecosystem that is fuelled by pharmaceutical companies. Companies partner with public researchers and healthcare providers at various research sites around the world, including hospitals, private clinics, and academic institutions.

…providers at various research sites around the world, including hospitals, private clinics, and academic institutions. Pharmaceutical companies fund and coordinate research studies, establish and maintain aggregate global databases, centrally coordinate data analysis, and communicate results to regulatory authorities and the public, locally and internationally. On account of their global reach, pharmaceutical companies are able to study larger, more heterogeneous samples by sharing information among their affiliates around the world, thereby improving the reliability and validity of research findings. Collecting and storing individual patient data is essential to maintaining the integrity and accuracy of aggregate data analyses. Analysts carefully review databases for duplicate cases, outliers, and anomalies.

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…www.efpia.eu 1 Response to the Commission Consultation on their proposal for a Regulation on Packaging and Packaging Waste (COM(2022) 677 final) - Pharmaceutical Industry considerations Author: EFPIA Circular Economy Network Date: 04/2023 Version: Final Introduction The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.

…develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. EFPIA welcomes the opportunity to share our feedback on the Proposal by the Commission on the Packaging and Packaging Waste Regulation (COM(2022) 677 final) (PPWR). The Commission proposal includes some derogations for packaging used in pharmaceuticals. We welcome this recognition that the pharmaceutical sector is one of the most regulated in Europe - and the world - operating effectively within an evidence-based framework to maintain the highest standards, and that our packaging plays a critical role in supporting the stability and storage of medicines, and ensuring that patient safety and product effectiveness are not compromised.

…the stability and storage of medicines, and ensuring that patient safety and product effectiveness are not compromised. There is, therefore, a need to carefully consider the requirements set for the sector to ensure we can continue to place medicines on the EU market. We remain cautious about the possibility for our industry to reach the objective of plastic packaging recyclability by 2035, as there is currently insufficient data to showcase how this will impact product safety. Importantly, it is essential that all requirements in the PPWR would recognize that the process for the introduction of a new immediate packaging material takes in average 10 years. An additional element to consider is whether the recycling infrastructure will be able to support the compliance with the proposed targets.

…to consider is whether the recycling infrastructure will be able to support the compliance with the proposed targets. While the healthcare sectors use of plastic packaging may be considered marginal, and the recycling of immediate and contact sensitive packaging would be expected to remain minimal, we are aware of and share society’s objective to minimise the use of packaging. EFPIA and our members are committed to environment sustainability, mitigating climate change and transitioning towards circularity. All our members have programmes exploring and/or implementing sustainability, circularity and design across the full medicine’s lifecycle, while patients’ and healthcare workers’ safety remains our priority.

…and design across the full medicine’s lifecycle, while patients’ and healthcare workers’ safety remains our priority. We acknowledge the existing challenges and barriers; however, we are also looking forward to future technologies that will enable us to adopt new solutions while ensuring continuous supply of medicines to patients. Ref. Ares(2023)2822266 - 21/04/2023 www.efpia.eu 2 The role of packaging in the pharmaceutical sector The packaging material of medicines is intended to protect and safely deliver the product to the patient and health care professionals. identify drug products until patient administration and/or use, and to include relevant information for product conservation.

…drug products until patient administration and/or use, and to include relevant information for product conservation. Through regulations, from the European Medicines Agency (EMA) it is required that the selected packaging proves to support and maintain product quality, safety, identity, sterility, purity and potency (Annex 1). Other requirements are related to serialization and validated sealing pharmaceutical packaging and on medical devices. User- friendliness for patients and safety of use (i.e. child resistant closures) are also important elements in designing immediate packaging of medicinal products (Directive 2001/83/EC)1. Safety for patients and healthcare practitioners administering medicines is the primary concern for EFPIA member companies.

…for patients and healthcare practitioners administering medicines is the primary concern for EFPIA member companies. While EFPIA members are investing in the improvement of medicines sustainability all along their life cycle, clarity is needed on the definitions of packaging in different legislations (PPWR, Pharma legislation and Medical Devices). Any change to the current framework must be coherent with the existing regulations and guidelines that govern the packaging criteria for pharmaceuticals and medical technologies. A list of regulations and guidelines that our sector must comply with is provided in Annex 1 of this document. Introducing new material in pharmaceutical packaging The normal process for introducing a new immediate packaging material for medicinal products already on the market would likely follow the process outlined in Figure 1.

…packaging material for medicinal products already on the market would likely follow the process outlined in Figure 1. To satisfy the evidence requirement that demonstrates that there is no negative impact to the product quality, safety and efficacy, a 10-year development is usually required for immediate packaging, whereas a 5-year (or less) accelerated pathway for outer packaging could be provided for. Drug-container closure suitability testing will need to be performed for immediate packaging. Suitability testing would include aspects on safety, performance, protection and compatibility ((these are typically aligned with the requirements for establishing a new Pharm Eur monograph per section 3 as described in guidance such as EMEA/CVMP/205/04 and the 1999 FDA Guidance on Container Closure Systems).

…section 3 as described in guidance such as EMEA/CVMP/205/04 and the 1999 FDA Guidance on Container Closure Systems). For devices biocompatibility (ISO 10993) for patient contacting components, processability, fit for function (including performance attributes) and fit for assembly aspects will need to be studied. The traceability and lot-to-lot consistency of such materials both need to be tightly controlled and managed. For each medicinal product, after preliminary studies of the packaging material/container closure system itself, process validation and stability studies with commercial scale batches of the drug product need to be conducted, the pharmaceutical quality documentation (Module 2.3 and Module 3) of the registration dossier updated, submitted and subsequently reviewed and approved by Health Authorities.

Module 3) of the registration dossier updated, submitted and subsequently reviewed and approved by Health Authorities. For pharmaceutical and medicinal products release testing, test methods should follow the same standards/requirements for product development and validation. They include but are not limited to (e.g. vials and ampoules): • Cytotoxicity 1 Directive 2001/83/EC Immediate packaging: The container or other form of packaging immediately in contact with the medicinal product. Outer packaging: The packaging into which is placed the immediate packaging. www.efpia.eu 3 • Biocompatibility • Bioburden • Particulate • Leachables and extractables • Sterile barrier integrity • Distribution and storage • Usability • Stability during sterilization and for shelf-life.

…barrier integrity • Distribution and storage • Usability • Stability during sterilization and for shelf-life. • Reproducibility of physical properties Figure 1: Processes for evidence generation of medicinal product quality. Specific points highlighted from the Proposal for a Regulation 1.1 Article 6: Recyclable packaging We welcome the derogations proposed for the immediate packaging of medicinal products. As a sector we are committed to support such innovation through partnerships to improve the packaging footprint of different products2,3, including the management of packaging and devices at the end of life.

…the packaging footprint of different products2,3, including the management of packaging and devices at the end of life. However, pharmaceutical products, due to the technical requirements such as cold chain requirements, sterile packaging, etc., use particular material like rubber stoppers and composite materials providing essential functionality to the packaging, and which are often difficult to recycle, e.g.: • Borosilicate glass used in vials because of the purity and high chemical resistance, • Stainless-steel needles attached to or provided with a syringe, • Coated stoppers to prevent leaching from the stoppers into the medicinal product, • Flip-off caps used to allow easy recognition of the contained product during production and when administering to the patient, • O-rings to ensure sealing and stability of the product.

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…www.efpia.eu 1 The EFPIA view of the Public Consultation ‘Reducing packaging waste – review of rules’ Author: Environment, Health and Safety Expert Group Date: 1/2021 Version: Final Introduction The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.

…develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. EFPIA, welcomes the opportunity to participate in the public consultation on the review of the requirements for packaging and other measures to prevent packaging waste: ‘Reducing packaging waste – review of rules.’ The pharmaceutical industry recognizes the need to shift towards a more environmentally sustainable future, including the European Commission’s goal to review and update the essential requirements of the Packaging and Packaging Waste Directive and by these means prevent packaging waste and set measurable targets and requirements to reduce the environmental impact of packaging.

…prevent packaging waste and set measurable targets and requirements to reduce the environmental impact of packaging. This statement aims to advance the key view of EFPIA, on the public consultation initiated by the European Commission and includes the following recommendations from EFPIA: • An exemption for the requirement to use recycled materials for primary packaging for medicinal products and medical devices (both primary packaging and device materials in direct contact with the medicinal product) • The scope of the updated Directive should provide clear guidelines for the pharmaceutical sector • Hurdles caused by conflicting requirements between the EU pharma law and the Packaging and Packaging Waste Directive should be addressed in the updated version of the Directive • EFPIA would be willing to work with Commission and relevant partners to identify the quality and supply chain…

…in seeking solutions to the safety issues around primary packaging in medicines and other highly regulated sectors. This could support relevant initiatives under the European Green Deal. EFPIA and its members would support with such a workstream Ref. Ares(2021)133581 - 07/01/2021 www.efpia.eu 2 Background The purpose of the open public consultation ‘Reducing packaging waste – review of rules’ is to gather views on possible measures to review Directive [Directive 94/62/EC] on Packaging and Packaging Waste aiming to improve packaging design to facilitate its cost-effective recycling and reuse and reduce the generation of packaging waste. The current essential requirements are at the core of the review.

…reuse and reduce the generation of packaging waste. The current essential requirements are at the core of the review. They specify standards and demands for: • the manufacturing and composition of packaging • the reusable nature of packaging • the recoverable nature of packaging The review conducted by the European Commission will include: • improving packaging design to promote reuse and recycling • increasing recycled content in packaging • tackling excessive packaging • reducing packaging waste. The EFPIA positioning on the Open Consultation Key points of view The pharmaceutical sector is one of the most regulated in Europe and the world, operating effectively within an evidence-based framework to maintain the highest standards, ensuring packaging never compromises patient safety or product effectiveness.

…to maintain the highest standards, ensuring packaging never compromises patient safety or product effectiveness. The packaging material is intended to protect and safely deliver the product to the patient and health care professionals. Packaging includes primary, secondary1 and tertiary2 units which are interdependent on each other. The purpose of packaging is to contain, protect, transport and identify drug product until patient administration and/or use. Through regulations, it is required that the selected packaging proves to support and maintain product quality, safety, identity, purity and potency. EFPIA member companies are also contributing to the reduction of waste by transitioning to a Circular Economy and ensure sustainable, safe and cost-effective recycling solutions for packaging materials originating from our sector. 1. Specific Measures of Dir.

…cost-effective recycling solutions for packaging materials originating from our sector. 1. Specific Measures of Dir. 94/62/EC Article 20 are needed for primary pharmaceutical packaging Taking into account that the EU Circular Economy Action Plan3 aims at having all packaging recyclable by 2030 while facilitating a transition to the use of high quality secondary raw materials, and that this target will be valid for the pharmaceutical sector as well, specific provisions for primary packaging4 for 1 Secondary packaging is the exterior packaging of the primary packaging that groups packages and protects or labels the pharmaceutical product. 2 tertiary packaging protects the product and the packaging when being transported. 3 COM (2020) 98 final 4 Primary Packaging refers to materials in direct contact with the medicinal product.

…3 COM (2020) 98 final 4 Primary Packaging refers to materials in direct contact with the medicinal product. Further information can be found in WHO Annex 9 Guidelines on Packaging for Pharmaceutical Products or ISO 15378:2011 Primary packaging materials for medicinal products www.efpia.eu 3 pharmaceutical products should be adopted in accordance with the article 205 of the current Packaging and Packaging Waste Directive. The definitions on primary and secondary packaging differ between the Packaging and Packaging Waste Directive and in the Pharma6 and Medical Device Regulations7. Deciding whether a drug container with a functionality, e.g. a cartridge with a moving plunger, should be considered a device (drug container) or a packaging material requires very specific and technical expertise.

…should be considered a device (drug container) or a packaging material requires very specific and technical expertise. The current EU regulatory framework doesn’t provide for enough clarity and certainty to define what falls within the scope of the Packaging and Packaging Waste Directive and EFPIA suggests including more examples on pharmaceuticals and medical devices in Annex 1 to support clarification of scope and harmonization across the EU. Reference8 gives an example of how this is done on national level in Belgium. The complexity of packaging has increased even more due to the requirements on serialization9 and validated sealing on medical device and pharmaceutical packaging. Since the tamper evident seals (or equivalent) cannot be broken by the dispensing pharmacy, the outer packaging will - in some EU member states – carry an instruction label with sensitive personal data (e.g.

…the outer packaging will - in some EU member states – carry an instruction label with sensitive personal data (e.g. name and personal identification number) that should not be exposed during the recycling process. Due to the high quality and purity requirements for medicines10 the use of recycled plastic content is not currently achievable for direct contact materials under present pharmaceutical regulatory requirements, as the manufacture of plastic containers for pharmaceuticals is required to preclude the contamination with other plastic materials or their ingredients. Product-contact packaging plays a critical role in the overall safety and efficacy of a healthcare (drug) product and the potential for unknown substances (contaminants) in the recycled plastic to interact with our products is of significant concern.

…for unknown substances (contaminants) in the recycled plastic to interact with our products is of significant concern. This concern is also addressed by the biological evaluation requirements (ISO10993) for primary containers with direct contact to the human body or the pharmaceutical product. To our knowledge, there has been no testing of the effect of primary packaging based on recycled plastics on medicine safety and there are very few recycled plastics available that meet the necessary quality grade for such testing. Our initial estimates – outlined below in Annex 1 – suggest that, once a suitable material is available for use, then the necessary development of packaging and testing would take substantial time and investment to meet the high standards, incl. the requirements of stability and safety, that regulators and industry deem essential.

…meet the high standards, incl. the requirements of stability and safety, that regulators and industry deem essential. 5 'The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Directive where necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Union, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging' 6 Ph. Eur.

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…www.efpia.eu 1 The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to provide comments on the Revision of the Customs Union Code. EFPIA represents the biopharmaceutical industry operating in Europe. Through its direct membership of 37 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy. EFPIA supports the objectives of the revision and wishes to highlight few elements that require further explanation.

EFPIA supports the objectives of the revision and wishes to highlight few elements that require further explanation. EFPIA recommends a specific focus on the pharmaceutical industry EFPIA applauds and fully supports the goal to achieve improved data collection and sharing between customs authorities and acknowledges the commitment of customs to adopt a “new strategic approach, driven by data analysis of supply chain information, in order to implement targeted and coordinated customs action.”1 Will the new strategic approach aimed to implement targeted and coordinated customs action prioritize certain industries or products where counterfeit versions pose the greatest risk to patients and consumers e.g. the pharmaceutical sector?

…or products where counterfeit versions pose the greatest risk to patients and consumers e.g. the pharmaceutical sector? Careful implementation of the EU Customs Data Hub EFPIA members appreciate the implementation of simpler customs processes through the EU Customs Data Hub, overseen by an EU Customs Authority. The proposal states that the information collected in the Data Hub will be utilized for risk analysis, with a single title for entry and exit respectively. This new "data paradigm" will gradually replace the current customs IT systems, transitioning from multiple systems in each Member State to a centralized set of systems and services. The use of this centrally developed environment will be mandatory.

State to a centralized set of systems and services. The use of this centrally developed environment will be mandatory. We would appreciate clarification from the 1 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing the Union Customs Code and the European Union Customs Authority, and repealing Regulation (EU) No 952/2013, p.15 EFPIA position on the revision of the Union Customs Review Author: Anti-counterfeiting & securities network Date: 06/11/2023 Version: Final Ref. Ares(2023)7541809 - 07/11/2023 www.efpia.eu 2 Commission regarding the timeline for this new system approach, as well as whether Member States will have the option to reject it. EFPIA would hope that this new data hub is mandatory for all Member States. EFPIA supports the utilization of existing sources of risk information at the Union level, including the IPEP, by the Data Hub.

…the utilization of existing sources of risk information at the Union level, including the IPEP, by the Data Hub. EFPIA hopes that the UCC will require interoperability not only with existing EU systems and databases such as the IPEP, but also non-EU databases including the WCO’s CENCOMM. Union level risk management activities, as proposed in Title IV Chapter 3 (article 50 – 55), Article 81 and Article 97 are extremely positive developments. EFPIA suggests that Recital 24 – 26 and Article 31 are amended to clarify that EU Law Enforcement authorities may also submit relevant data to customs authorities. EFPIA applauds the proposal in Article 252 (1) for Union customs infringements to include provision of incomplete and inaccurate information, but warries that the sanctions in article 254 should be set at a level which ensures that bad actors are deterred from doing so.

…that the sanctions in article 254 should be set at a level which ensures that bad actors are deterred from doing so. EFPIA welcomes the introduction of a structured cooperation framework with authorities in Article 240 and the clarification that this will include the exchange and analysis of information (Recital 58). Request for clarification risk analysis EFPIA welcomes the proposal for introduction of new Union-level risk management activities, including common risk analysis and the issuance of corresponding Union control recommendations to customs authorities. It also allows for the potential instruction that goods destined for the Union may not be loaded or transported. We kindly request the Commission to clarify the origin of the Union-level data and the parameters on which the analysis will be based.

…the Commission to clarify the origin of the Union-level data and the parameters on which the analysis will be based. Will the data only consider large containers and truck shipments, or will it also include small parcels? Furthermore, we seek further clarification on how the risk analysis for pharmaceuticals will be conducted, including parameters such as country of origin, consignee, weight, and declaration, among others. Collaboration is key The review introduces a cooperation framework involving market surveillance, law enforcement, Union agencies, and bodies such as Europol and Frontex. This collaboration has been crucial in combating counterfeit goods for the past two decades. EFPIA would like the UCC to provide more detail on what changes will be made to ensure that cooperation is successful.

EFPIA would like the UCC to provide more detail on what changes will be made to ensure that cooperation is successful. Compliance controls The roles of individuals accountable to customs, such as declarants and carriers, will be modified to assign compliance responsibility to importers and exporters. These entities must www.efpia.eu 3 be established within the EU's territory and register with the Member State of establishment, with listed exceptions. EFPIA members support this change, but are wondering how due diligence will be conducted for non-compliant importers, exporters, or non-existing parties.

…but are wondering how due diligence will be conducted for non-compliant importers, exporters, or non-existing parties. Can the UCC proposals include clarification as to who will be responsible for verifying this information and what actions Customs will take if an exporter/importer is not registered in the EU and the goods are claimed to be in transit but are actually being unloaded within the EU? The UCC should also indicate how Customs will follow up on such cases. EFPIA suggests that these provisions should be extended to make clear that it applies also to importers and exporters of goods which are in transit across the EU. EFPIA strongly supports the proposal in Rectial 34 for different actors in the supply chain to provide relevant information on goods, linked to a specific consignments.

…for different actors in the supply chain to provide relevant information on goods, linked to a specific consignments. Also, for importers to provide information on goods to customs etc before the goods physically arrive (see also Article 80). EFPIA suggests that failure to comply with the conditions for placing goods on the market in the EU (Article 88(3)(d)) should be included in the list of Union customs infringements in Article 252 and should attract deterrent sanctions. EFPIA welcomes the removal of the EUR 150 thresholds under which customs duties are not charged, in Recital 48. This should lead to identification of counterfeit medicines which have previously benefitted from being imported in small consignments with a low declared value.

…medicines which have previously benefitted from being imported in small consignments with a low declared value. Online sellers and e-commerce platforms EFPIA supports that online sellers and e-commerce platforms will be deemed as importers, thus obliged to provide to the customs authorities not only the data necessary for the release for free circulation of the goods sold to consumers in the EU, but also the information that they must collect for VAT purposes.

…circulation of the goods sold to consumers in the EU, but also the information that they must collect for VAT purposes. Determination of risk In Recital 13, a notable statement is made: "The persons responsible for the goods entering and exiting the customs territory of the Union are liable for any risks posed by the goods to the safety, security, health, life, environment, or consumers." This recital requires some clarification and EFPIA strongly recommends that this is strict liability so that counterfeiters are not able to evade sanctions by claiming that they had no knowledge as to the risky nature of the goods. The burden should be on the importer to demonstrate that the goods do not represent a risk. This is particularly important where pharmaceutical products are concerned.

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originalus šaltinis (PDF) ↗