The PPWR spares the medicine's own pack but not its carton or shipper, and pharma packaging targets cluster where the law still bites

What the PPWR exempts, and what it does not

The PPWR has applied since 12 August 2026 and covers packaging across its life cycle, from substances to recyclability, recycled content, minimisation, labelling, reuse and EPR (PR-EU-001). Medicines are not carved out of its scope. They are carved out of specific duties, and Exhibit 2 sets out which, paragraph by paragraph, from official texts consulted on 22 October 2026.

SPI has not yet confirmed every article reference against the operative text in the Official Journal, so the article references below rest on three official sources: the recitals of Regulation (EU) 2025/40, the Commission’s Guidance Notice C/2026/3084 of 10 June 2026, and the Commission’s PPWR FAQ, August 2026 edition (catalogue KH-01-26-068-EN-N). The EUR-Lex summary, last updated on 26 September 2025, confirms that the recycled-content rule has exceptions for pharmaceutical packaging and medical devices.

Recyclability. Recital 34 says recyclability requirements should not be mandatory for immediate packaging under Directive 2001/83/EC and Regulation (EU) 2019/6, and extends this to outer packaging where it is needed to preserve the quality of the medicinal product, and to contact-sensitive plastic packaging of devices under Regulations (EU) 2017/745 and 2017/746. The FAQ (section IV, Q2) says the exemptions are listed in Article 6(11) and that the Commission cannot grant further ones. Its answer on the review date (section IV, Q9) gives 1 January 2035 and names the lightweight-material exemptions; SPI has not yet confirmed from the operative text whether the medicines exemption is reviewed on the same date or carries its own deadline.

Recycled content. Recital 38 grounds the Article 7 exclusion in human and animal health and the safety and supply of medicines and devices, and applies it to outer packaging where that packaging must meet specific requirements to preserve the quality of the medicinal product. The FAQ (section V, Q9) says immediate packaging will generally qualify as contact-sensitive packaging, and that the two terms should be read the same way when Article 7 is applied. The sister piece on PPWR recycled-content targets covers the floors themselves.

Definition. The Commission Notice says intravenous bags and syringes are outside the packaging definition, including when pre-filled, because they form an integral part of the medicinal or medical product. A blister tray holding pre-filled syringes in a vaccine pack is packaging, which is why Sanofi’s blister-free goal matters for its EU compliance file.

The pack stack: a four-layer ladder of exposure

SPI groups pharma and consumer health packaging into four layers, set by what a pack does for the medicine and which law governs it (Exhibit 3). The layers are an SPI device for sorting SKUs, built from the PPWR texts above and the company disclosures below; they are not legal categories.

Layer A is where a pharma packaging team has the least freedom, because any change to the immediate pack is a variation to the marketing authorisation, and it is where the PPWR asks the least. Layer C is where the team has the most freedom and the PPWR asks the most. Layer B sits between them, and Layer D is where the carbon is, at least for an inhaler maker.

The ladder also explains a split that SPI’s Buyers Database shows across its 42 company profiles. Prescription medicine makers set targets on formats and process, such as blister removal and eco-design plans, while consumer health groups set portfolio-wide percentages in the same terms as personal care brands. The food and FMCG pledges piece covers how those portfolio targets work; this piece covers the layers that make medicines different.

Safety features and the limits of minimisation

The Falsified Medicines Directive, Directive 2011/62/EU, amended Directive 2001/83/EC to require safety features on medicine packs, and Commission Delegated Regulation (EU) 2016/161 sets out how. It has applied since 9 February 2019 (Article 50). The safety features are a unique identifier, encoded in a two-dimensional barcode, and an anti-tampering device, defined in Article 3(2)(b) as the feature that allows a check of whether the packaging of a medicinal product has been tampered with.

The PPWR does not mention the safety features in the recitals SPI read, but the Commission’s FAQ answers the question indirectly. In explaining Article 10, it lists child resistance, anti-tamper, anti-theft and anti-counterfeit features, hazard warnings and specific product characteristics among the functions a pack shape may need, and says the updated minimisation standard will take shape into account (FAQ, section VII, Q6). Until the end of 2029 the older essential requirements and EN 13428:2004 still apply, and the Commission is to request an updated standard by 12 February 2027 (FAQ, section VII, Q1 and Q3).

Recital 60 sets the test the safety features must pass: packaging should keep its weight and volume to the minimum needed to perform its functions, and marketing or consumer acceptance alone does not justify extra weight or volume. A tamper seal and a readable barcode are functions. A carton sized for shelf impact is not.

National EPR: the same pack, three national answers

EPR fees are national, and none of the official sources cited here exempts medicine packaging from them. What changes from country to country is which stream a pack belongs to, how it is rated and who collects the medicine left inside it (Exhibit 5).

United Kingdom: household or non-household

The UK’s packaging EPR regulations (PR-GB-002) charge disposal fees on household packaging only, so the classification is the opening cost question for a medicines producer. GOV.UK’s guidance, published on 11 March 2024 and updated on 5 August 2025, treats primary and shipment packaging as household unless specific conditions are met, and says secondary and tertiary packaging must be classed as non-household. Its Example 9, a healthcare manufacturer selling through a wholesaler, shows how the line runs through a pharmacy (Exhibit 6).

The guidance asks for evidence such as binding agreements on onward supply, customer sales records, signed declarations or product specifications showing specialist use, kept for at least seven years. A vaccine maker supplying clinics can therefore move much of its primary packaging out of household fees, while an OTC brand selling through pharmacies and supermarkets cannot.

Fee modulation adds a second UK question. PackUK’s modulation statement creates three medical reporting codes, green-medical, amber-medical and red-medical, and says medical packaging is not exempt from modulation because some of it is recyclable. Packaging that is red by virtue of a regulatory requirement is reported as amber-medical and pays the amber fee, while other red medical packaging pays the red factor of 1.2 in 2026-27, 1.6 in 2027-28 and 2.0 in 2028-29 (PR-GB-003). Evidence supporting the recyclability assessment must be supplied for amber-medical and red-medical returns.

The Plastic Packaging Tax runs alongside. HMRC’s guidance says plastic packaging for the immediate packaging of licensed human medicinal products is not subject to the tax, but must be counted when working out the 10-tonne registration threshold; the rate is GBP 228.82 per tonne (PR-GB-001). The guidance does not distinguish prescription from non-prescription medicines, so the test is the MHRA licence, not the sales channel. It does not extend the relief to outer or transport packaging.

France: Cyclamed and the household bin

France splits the medicine pack at the pharmacy counter. Cyclamed, the eco-organisation for unused human medicines, has operated since 1993 and is approved by the public authorities; it brings together community pharmacists, wholesaler-distributors and pharmaceutical companies (cyclamed.org). Its sorting guidance sends expired or unused medicines back to the pharmacy, with tablets and capsules left in their blisters, and sends the empty cardboard carton and paper leaflet to the household recycling bin. Used syringes and needles held by households are a separate healthcare waste stream.

Cyclamed reported on 26 June 2026 that 8,289 tonnes of unused medicines were collected in pharmacies in 2025 and that 7 in 10 French people now separate cardboard cartons and paper leaflets correctly before bringing the rest back (Exhibit 7). SPI analysis: in France the carton and leaflet behave like any household paper packaging, while the blister travels with the medicine into a pharmacy take-back stream; a design that makes the carton easy to separate from the blister supports both streams.

Spain and Germany

Spain’s tax on non-reusable plastic packaging, EUR 0.45 per kg of non-recycled plastic, exempts packaging for medicines, medical devices, special medical foods, hospital infant formula and hazardous healthcare waste, provided the buyer gives a prior declaration of exempt use (PR-ES-001). Using goods bought under the exemption for another purpose carries a penalty of 150% of the unpaid tax, with a minimum of EUR 1,000. Royal Decree 1055/2022 separately brings commercial and industrial packaging into EPR (PR-ES-002), which reaches Layer C. In Germany, the VerpackDG has replaced the old packaging act since 12 August 2026 and requires registration and system participation for sales packaging, which covers medicine cartons (PR-DE-001).

Blister packs and inhalers

Blisters and inhalers are the two formats where pharma packaging departs furthest from consumer goods. A thermoformed blister combines a plastic film, often PVC, with an aluminium lid, and the PPWR’s recyclability exemption for immediate packaging means no EU deadline forces it to change. Two of the four companies are changing it anyway.

Sanofi’s PVC-free initiative, started in 2022, aims to reduce or where possible remove PVC from secondary and tertiary packaging, and its blister replacement work is at feasibility and pilot stage (Sanofi Eco-design factsheet, July 2026). Its Pre-Filled Safety Syringe is moving to a mono-material approach using PET/PETG with 50% chemically recycled content. Haleon works with the Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) on blister recycling, and says there is currently no commercially viable recycle-ready solution for its Theraflu sachets (Haleon Health Inclusivity and Sustainability Report 2025).

The inhaler question is a propellant question. Regulation (EU) 2024/573 on fluorinated greenhouse gases brings the metered dose inhaler sector into the HFC quota system. Recital 20 says the mechanism will guarantee full quota for the sector, matching its most recent market share, for 2025 to 2026, and that the sector reaches the full reduction rate of the other sectors only in 2030. Article 12(1)(f) adds labelling for aerosol dispensers containing fluorinated gases, including metered dose inhalers.

GSK’s statement of 4 September 2026 says the Ventolin metered dose inhaler accounts for approximately 43% of the company’s total carbon footprint, and that the HFA-152a version could cut greenhouse gas emissions by approximately 92% per inhaler. GSK’s earlier phase III release of 22 October 2025 gave 45% of the footprint, as recorded in SPI’s profile; the 2025 report and the September statement both give 43%. SPI analysis: for an inhaler maker, the propellant switch is likely to move carbon totals more than any change to the canister, actuator or carton, and it is governed by F-gas and medicines law rather than by the PPWR.

What the four companies report

Each company measures packaging in its own unit and boundary, so Exhibit 9 sets them side by side without adding, averaging or ranking them. All figures are as published by each company on the date shown.

SPI calculation: Haleon’s plastic tonnage fell 9.7% year on year (62 to 56 thousand tonnes) while total packaging fell 4.2% (143 to 137 thousand tonnes), so plastic’s share of its packaging fell from 43.4% to 40.9%. The virgin plastic figure of -9% against 2022 is a different measure and should not be read from these tonnes.

Exhibit 11 maps each company’s disclosed actions onto the pack stack.

Scenarios: what UK classification and ratings do to a consumer health bill

The UK is where the household question and the medical codes turn into money soonest. SPI priced a 100-tonne UK household packaging mix shaped like Haleon’s reported materials (54.7 tonnes paper and board, 41.4 tonnes plastic, 3.7 tonnes glass and 0.2 tonnes aluminium, scaled from the 2025 ESG Databook) at PackUK’s Year 2 illustrative fees (Exhibit 12). The mix is an SPI assumption, not Haleon’s UK tonnage, and every figure is in sterling.

The working is short. At amber, 54.7 x 210 + 41.4 x 455 + 3.7 x 205 + 0.2 x 270 = GBP 31,136.50, of which plastic is GBP 18,837, or 60.5%. Rating all plastic red at Year 2 rates adds 41.4 x 90 = GBP 3,726. At the 2027-28 factor applied to the amber rate, red plastic would cost GBP 728 per tonne, and the plastic line alone would be GBP 30,139.20.

Exhibit 13 sets out the pace each company needs on its own metric. Each row is in its own unit and is not compared with any other.

SPI calculation: GSK’s 3% reduction from 2022 to 2025 is about 1.0 point a year, against 1.4 points a year needed to 2030. Sanofi’s 60% of its top 20 products is read by SPI as 12 products, which matches the 12 products the factsheet names. Haleon reports passing -10% by the end of 2025 on results to 30 September 2025, so its row starts from the -9% reported for the year to 30 June 2025.