Legal experts: Environmental law can be daunting but having a plan helps
Jilles van der Hoek (left) and Cécile van der Heijden (right) spoke at the RAPS Regulatory Intelligence Conference Europe. (credit: Ferdous Al-Faruque)
BARCELONA – Navigating Europe’s complex environmental and sustainability legislation can be daunting, but healthcare product manufacturers can take concrete steps to ensure they remain compliant, according to two legal experts who spoke at RAPS Regulatory Intelligence Conference Europe on Tuesday.
Cécile van der Heijden and Jilles van der Hoek, attorneys with Axon Lawyers, discussed more than a dozen pieces of legislation already in effect, under revision, or that have been proposed that create environmental and sustainability requirements for drug and medical device manufacturers in the region.
The attorneys said that some of the legislation, such as the Medical Device Regulation (MDR) and the proposed New Pharmaceutical Legislation, directly affect the medical device and pharmaceutical industries in the EU and European Economic Area, whereas other pieces of legislation, such as the Battery Regulation and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), are broader pieces of legislation that may indirectly affect healthcare product companies. They also added that a single piece of legislation may cover certain aspects addressed by another, but that doesn't mean they can pick and choose which legislation to comply with, and it is a manufacturer’s responsibility to comply with all legislation that affects their products.
Van der Heijden reviewed key dates for upcoming legislative requirements and recommended that regulatory professionals keep a calendar on their wall based on those that affect their products and develop a plan to ensure they don't miss any deadlines. She emphasized that 2027 is a very important year, with four regulatory obligations taking effect, including a requirement for EU member states to set penalties for violations of the Packaging and Packaging Waste Regulation (PPWR), which means there will be enforcement for non-compliance.
To stay on top of regulatory requirements, van der Heijden said manufacturers should map which requirements apply to their specific products rather than reading all the legislation, which can be very daunting. She said manufacturers should ask what their products contain that may be affected by the legislation's environmental provisions and then read the applicable legislation. She also said they should look up the timelines for complying with those pieces of legislation and figure out whether their product may be excluded or have exemptions. If there is an exemption, she said they should determine whether it is a hard exemption or one that eventually comes to an end.
"You should identify which requirements apply to the product itself, which apply to the components, to the substances, to the packaging, or to the end of life," said van der Heijden. "Again, timelines are essential here; you don't want to miss transitional periods.
"Ideally, I think what's most practical is to create a product by legislation applicability matrix," she added. "Again, you can do this however you think it's practical but bring the information together because if it exists across 15 files or across 15 people, none of you will have the overview, and that's what you want to avoid."
After determining which legislation applies to specific products, van der Heijden said the next step is for companies to map out their legal roles under each regulation or directive and the member-state law that applies to them. She said that also means determining their company's role, such as whether the company is the manufacturer, importer, distributor, or another regulated economic operator. It is important to do this legal mapping for each product and to remember that the same company may have different roles under different pieces of legislation, she added.
For harmonized products, van der Heijden recommended that companies use the EU Blue Guide because product definitions in legislation may not align, and the guide can offer a clearer understanding of how their product fits and help them find a common denominator when defining it. As an example, she emphasized that companies shouldn't assume that their roles under the MDR, the In Vitro Diagnostics Regulation (IVDR), or the New Pharmaceutical Legislation also determine their roles under other environmental legislation.
Van der Hoek echoed those sentiments and said the Blue Guide is an important legal resource for companies.
"We get a lot of questions that can easily be answered by looking at the Blue Guide," he said. "Not that we don't mind answering them, but it's probably more convenient for you to consult the Blue Guide."
The third step in addressing environmental regulations, according to van der Heijden, is to identify which actions to take based on the requirements and implement them. She said this includes identifying design requirements, such as whether the product's batteries must be removable and recyclable; information requirements, such as labeling and instructional needs; and technical documentation requirements. She also said that, at this point, they should consider registration, reporting, and financial requirements and conduct a gap analysis against their existing product and quality system.
Van der Heijden noted that some of the information they need to provide under environmental legislation may be held by a partner company, such as the packaging supplier, so their company needs to know whom to ask for it.
Van der Hoek emphasized that companies "don't have to reinvent the wheel" and can rely on their supplier for many of the evidentiary requirements. However, van der Heijden added that some suppliers may not be as forthcoming with information that could put the product manufacturer in a bind, but they need to keep pushing for the information to protect themselves from potential enforcement.
"It's very simple, you just build the requirements into your supplier agreements and specifications because if it's in the contract, you can also hold your supplier to provide you with that information," said van der Heijden. "You have grounds to get rid of them if they don't give you the information.
"Contracts will help you to enforce your own obligations, require updates when material or components change, retain evidence in a compliance file, and validate critical supplier information where necessary," she added. “Then you have to make sure that you assign internal ownership, and you set up triggers for reassessment."
Van der Heijden stressed that internal reassessment triggers are extremely important when there are design changes, supplier material changes, new substance restrictions, and more. If such triggers are not written down, she said they might be missed, or the person monitoring those issues may leave the company, which could ultimately lead to non-compliance.
Van der Hoek noted that enforcement is largely managed at a national level, but there is coordination at the EU level and member states have designated their own competent authorities and established national enforcement regimes. This means the penalties are also determined at the national level, though there are certain legislative requirements that the penalties are effective, proportionate, and dissuasive, he said. He added that regulatory authorities cooperate and exchange information across the EU, which means enforcement may differ between member states.
"But if there is enforcement in one member state, it's very likely that other member states will also look at your products," emphasized van der Heijden. "So don't rest once you've handled it in one member state.”
Van der Hoek added that if an authority finds potential noncompliance through an inspection, market surveillance, a complaint, or other means, it may ask the economic operator to investigate the issue and correct it. However, if non-compliance persists after that, or if intervention is needed, he said they may restrict, prohibit, or withdraw the product, require a recall, and take administrative measures or levy penalties.
While in many instances penalties have not yet been established, van der Hoek said this doesn't mean the company or its product won't face consequences, as it may be forced to take corrective actions.
