Associazione delle Imprese del farmaco

PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND THE EUROPEAN COUNCIL ON PACKAGING AND PACKAGING WASTE, AMENDING REGULATION (EU) 2019/1020 AND DIRECTIVE (EU) 2019/904 AND REPEALING DIRECTIVE 94/62/EC (NO .COM (2022) 677 FINAL) INTRODUCTION Farmindustria thanks the Commission for this opportunity to provide its contribution on such an important issue for the sector. The position expressed below is in line with and implemented in Confindustria position. Farmindustria is the Italian National Association of Pharmaceutical Companies, which has approximately 200 member companies operating in Italy, both italian-owned and foreign- owned companies, with over 120 manufacturing sites all over the country and over 68,000 highly qualified employees.

…companies, with over 120 manufacturing sites all over the country and over 68,000 highly qualified employees. It is member of Confindustria, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). THE PHARMACEUTICAL INDUSTRY'S COMMITMENT TO ENVIRONMENTAL SUSTAINABILITY The pharmaceutical industry is committed to ecological transition, also thanks to important investments aimed at improving the efficient management of resources: water treatment, reduction of waste and use of plastic and reduction of energy consumption. In the last ten years the pharmaceutical sector in Italy has reduced energy consumption by 44%, a percentage that rises to 51% for consumption related to atmospheric emissions.

…has reduced energy consumption by 44%, a percentage that rises to 51% for consumption related to atmospheric emissions. According to Istat data, it is the sector with the highest percentage of companies to have introduced (that introduced?) innovations for reducing the consumption of materials or water per unit of product. These results come from growing investments in green technologies. In 2015, the Eco-Pharma Stewardship (EPS) was created, which is the European program for the intelligent and sustainable management of the environmental impact of the medicines throughout their life cycle.

…the intelligent and sustainable management of the environmental impact of the medicines throughout their life cycle. Back in 1980, Farmindustria – together with the supply chains of both private and public pharmacies (Federfarma and Assofarm) and of pharma distributors (ADF and Federfarma Servizi) – established Assinde, a centralized system to guarantee the correct disposal of expired medicines, considered according to current legislation, ‘medical waste requiring special management systems’ 1. This makes Italy the first country in Europe to have such organization. In 2016, Assinde, with the Ministry of the Environment, signed a framework agreement for the management of waste produced in the pharmaceutical manufacturing and distribution cycle, that includes all types of waste present in the manufacturing sites. Since 1 DPR 15 July 2003, no. 254 Ref.

…cycle, that includes all types of waste present in the manufacturing sites. Since 1 DPR 15 July 2003, no. 254 Ref. Ares(2023)2886081 - 24/04/2023 2 2003, Assinde has ensured the correct disposal of over 1,000 tons of pharmaceutical waste every year. In addition, with a view to paying even greater attention to the environment and following the provisions of the Italian Medicines Agency (AIFA), our sector created the Farmastampati system that allows pharmacists to continue to dispense medicines until they expire, replacing package leaflets when they are updated. The pharmaceutical industry shares the goal of making Europe the first climate-neutral continent, in accordance with the European Green Deal and the Circular Economy Plan.

Europe the first climate-neutral continent, in accordance with the European Green Deal and the Circular Economy Plan. Nevertheless, the need for ensuring patients’ and healthcare professionals’ safety as well as continuity of supply are the first objectives and priorities of any future green technology implemented by the pharma sector. The proposal for a Regulation for the revision of the legislation on packaging and packaging waste raises concerns both for the direct impacts on the sector – in particular for the development and manufacturing of new recyclable pharmaceutical packaging, as highlighted in detail hereafter – and for the indirect impacts on the supply chain as well as for the recessionary effect that the measure would have on the Italian economy.

…impacts on the supply chain as well as for the recessionary effect that the measure would have on the Italian economy. Furthermore, the ban of certain non-recyclable packaging, when used in the pharmaceutical sector, in the absence of alternatives that guarantee the quality of the medicine, would put at risk the marketing of effective and safe medicines, limiting the right to care and impacting the health of patients both in Italy and in Europe. SPECIFIC REMARKS FOR THE PHARMACEUTICAL SECTOR AND PROPOSALS 1. RECYCLABILITY OF IMMEDIATE PHARMACEUTICAL PACKAGING- ARTICLE 6 Article 6 of the proposal for a Regulation foresees that immediate pharmaceutical packaging (i.e. packaging directly in contact with the medicine) must be recyclable, designed for recycling and recycled at scale from 1st January 2035.

…in contact with the medicine) must be recyclable, designed for recycling and recycled at scale from 1st January 2035. It also proposes that packaging can be recycled so that the resulting secondary raw materials are of sufficient quality to substitute the primary raw materials. In this respect, the derogation to 2035 in the legislative proposal for immediate pharmaceutical packaging is welcomed, but we believe that this derogation should be made permanent. In fact, we question the feasibility of such stringent recyclability requirements for pharmaceutical packaging for the following reasons: x Immediate pharmaceutical packaging is subject to specific and detailed regulation. The pharmaceutical sector is one of the most regulated in Europe and worldwide, operating effectively within an evidence-based regulatory framework.

…one of the most regulated in Europe and worldwide, operating effectively within an evidence-based regulatory framework. Through regulation, from European Medicine Agency (EMA), it is required that the selected packaging proves to support and maintain product quality, safety, efficacy, sterility, purity, identity. Any changes to the current regulatory framework must be aligned with existing regulations and guidelines governing the packaging 3 criteria for pharmaceutical products and with those being currently defined (in line with the upcoming revision of Pharmaceutical Legislation). See Annex 1 for regulations and guidelines currently in force. x Immediate pharmaceutical packaging must be approved by the Medicines Regulatory Agencies.

…currently in force. x Immediate pharmaceutical packaging must be approved by the Medicines Regulatory Agencies. Technical description of the immediate packaging is part of the pharmaceutical quality documents (Module 2.3 and 3) of the Marketing Authorisation Application (MAA) to be submitted to and assessed by the Competent Health Authorities. Any change in the pharmaceutical packaging would lead to the submission of a considerable number of applications for variations of the Marketing Authorisation (MA) for pharmaceutical products marketed in Europe, with a huge bureaucratic burden for the EMA and for all the National Regulatory Authorities (AIFA in Italy) with potential slowdowns in activities related to the protection of public health (i.e., evaluation, approval and supervision of aspects of quality, efficacy and safety of medicines).

…of public health (i.e., evaluation, approval and supervision of aspects of quality, efficacy and safety of medicines). x Immediate pharmaceutical packaging is contaminated with the medicine and can compromise waste stream. In some cases, the immediate packaging is ‘contaminated’ with the medicine (i.e., the vial or bottle when the medicine is a liquid). In such cases, placing the packaging in a defined waste recycling stream would contaminate the stream and compromise the recyclability of the other waste. Additionally, the direct contact between the immediate packaging and the active substance/biological product leads to contamination of the immediate packaging by residues of active pharmaceutical ingredients or impurities.

…leads to contamination of the immediate packaging by residues of active pharmaceutical ingredients or impurities. Secondary raw materials resulting from possible recycling of materials may not be of sufficient quality to substitute the primary raw materials of the immediate packaging. This poses a real threat of contamination, and this is especially relevant in case of highly potent or mutagenic substances such as cytotoxic agents. x The development of a new (or modified) immediate pharmaceutical packaging is a long and complex path. 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.

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