Three Questions with Rachel Cockburn Buhl: The EU Medicines Directive and Parallel Imports

Rachel Cockburn Buhl (Ferring Pharmaceuticals, Denmark)

In April 2023, the European Parliament adopted the EU Commission’s proposed revision of the EU pharmaceutical legislation, including a new Medicines Directive which includes a new provision, Article 67(7)(a): “For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.” INTA drafted a position statement on this amendment.

In a conversation with the INTA Bulletin, Parallel Imports Committee (PIC) Vice Chair Rachel Cockburn (Ferring Pharmaceuticals, Denmark) breaks down the potential consequences of implementing Article 67(7)(a) on parallel-imported pharmaceutical products, talks about its other possible impacts on patient safety, sustainability, and EU harmonization, and describes the Association’s official position and advocacy efforts on this subject.

Please explain the possible consequences of Article 67(7)(a) for the treatment of parallel-imported pharmaceutical products compared to the current process.
The possible consequences of Art67(7)(a) are far-reaching and complex. Decades of jurisprudence have carefully considered balancing the competing interests of the free movement of goods and trademark exhaustion in the European single market against the legitimate interests of inter alia protecting the essential function of trademarks to guarantee the origin of a trademark-protected product and assuring that it has not been illegitimately interfered with.

Parallel importing medicinal products within the EU requires that the product packaging be adapted to the legal requirements and language of the import market. Packaging must be opened to replace patient information leaflets, and new labeling must be affixed. Such changes have long been recognized as creating an inherent risk to the essential function of the trademark and to the condition of the product (and, thereby, to patient safety).

It is also well accepted that this interference and risk is greater when importers adapt the product packaging by repackaging in new outer packaging (re-boxing) rather than by applying new labels to the original packaging (re-labeling).

This is why, until now, re-boxing was only allowed in limited circumstances where it was objectively necessary to gain effective access to the import market—where it would be otherwise impossible to sell the products in that market. Absent objective necessity, the original packaging had to be used and adapted by re-labeling. The application of Art67(7)(a) will mean that it will always be objectively necessary for importers to re-box medicinal products in member states implementing the article. Re-boxing will be the general rule rather than the exception. Brand owners will be prevented from exercising their trademark rights to oppose re-boxing even though it constitutes a greater interference with the product and the trademarks.

What other impacts could arise from the application of Article 67(7)(a)?
In addition to the significant weakening of the rights of originator brand owners to protect their products and their consumers, various other interests are also impacted: patient safety, sustainability, and EU harmonization.

The function of pharma brands is not only to guarantee origin but to protect patients. This is why national regulators stringently examine medicinal product names to avoid risks of medication error. Art67(7)(a) is claimed to be “for the purposes of patient safety,” but there is no empirical evidence that re-boxing would increase patient safety. The Court of Justice has consistently held that re-boxing does not ensure greater patient safety and, very recently, specifically rejected this claim.

Additionally, re-boxing practices have often involved a replacement of the complex originator-branded packaging with lower cost, plain, and even de-branded cartons. The purpose of the original packaging and product branding is to guarantee the source of the product, distinguish products from one another, and prevent medication errors. Removing them (and other safety features often applied by originators) in the process of re-boxing cannot promote patient safety. Mandatory re-boxing would also create significant waste and a potential supply of original packaging for counterfeiters and falsified products.

Finally, requirements for the authorization and labeling of medicinal products are harmonized at the EU level. Allowing EU member states to choose whether imported products should be re-boxed or not would lead to a patchwork of rules across the single market.

Is INTA undertaking any advocacy efforts in regard to Article 67(7)(a)?
INTA is leveraging its extensive expertise and advocacy capabilities to raise awareness of the complex and far-reaching, but seemingly overlooked, consequences of Art67(7)(a). The PIC has developed a position paper to speak with “one advocacy voice” and to assist members in understanding how the well-reasoned balance between competing interests might be affected. The paper has been shared with health attachés from EU 27 member states, the EU Directorate-General for Health and Food Safety (DG SANTE), the Commissioner’s Office, and intellectual property offices.

Although every effort has been made to verify the accuracy of this article, readers are urged to check independently on matters of specific concern or interest.

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