Anti-tampering devices – fading boundaries of parallel trade?

Introduction
Falsified medicines legislative package
Implications for parallel trade and objective necessity to rebox


Introduction

On 9 February 2019 a legislative package aimed at fighting falsified medicines will enter into force in the European Union. Pharmaceutical companies will be required to affix a so-called 'anti-tampering device' on all prescription medicinal products to allow verification of whether their packaging has been tampered with.

Parallel importers have asserted that anti-tampering devices provide an overarching objective necessity to rebox parallel import medicinal products. They argue that the original packaging should need to be opened and an anti-tampering device broken so that the original box cannot be reused due to the mark that the anti-tampering device will leave. Such a free pass would remove the first Bristol-Myers Squibb condition of 'objective necessity' stipulated by European Court of Justice case law and seems to have been contradicted by the European Commission's (ECJ's) guidance in this regard.

Falsified medicines legislative package

The EU Falsified Medicines Directive (2011/62/EU) aims to fight falsified medicines(1) by imposing various measures, such as good manufacturing practices for active substances and the implementation of obligatory safety features. The latter are detailed in EU Regulation 2016/161 and will apply as of 9 February 2019. This EU legal framework has been transposed into Belgian law through the Medicines Act(2) and the Royal Decree concerning medicines for human and veterinary use.(3)

The safety features required are twofold. First, a unique identifier should help to verify the authenticity of an individual medicinal product through an encoded two-dimensional barcode.(4) Further, an anti-tampering device should:

• verify whether a medicinal product's packaging has been tampered with; and
• prevent falsified medicinal products from entering into the legal supply chain.

These safety features must be affixed to medicinal products subject to prescription, although exceptions are set out in Annex I and II of EU Regulation 2016/161.(5)

Implications for parallel trade and objective necessity to rebox

Parallel imports are considered lawful only if the parallel importer is able to show that five cumulative conditions have been met (ie, the Bristol-Myers Squibb conditions).(6) The first condition requires that repackaging is objectively necessary. The importer must prove that the proprietor's reliance on trademark rights to oppose the marketing of the over-stickered or reboxed product under said trademark would contribute to the artificial partitioning of the market between EU member states. On that basis, Belgian case law has considered reboxing to be objectively necessary only when the original box can no longer be used and thus when over-stickering prevents market access to the market of the EU member state of import.

In anticipation of the EU Falsified Medicines Directive's entry into force and the anti-tampering device obligation, parallel importers have argued that, among other things, when replacing patient information leaflets, the original box should be opened and the anti-tampering device should be broken. As a result, the original box cannot be reused in view of the mark that the anti-tampering device would leave. In other words, the EU Falsified Medicines Directive has created an overarching objective necessity to rebox parallel import medicinal products.

Accepting such a position would effectively grant parallel traders a free pass to rebox virtually all prescription medicines and therefore effectively nullify the use and purpose of the first Bristol-Myers Squibb condition. Nonetheless, Recital 29 of the EU Falsified Medicines Directive clearly states that "[t]his Directive is without prejudice to provisions concerning intellectual property rights" and therefore the Bristol-Myers Squibb conditions too. A balanced, case-by-case approach is thus required to deal with this issue.

This position seems to have been confirmed by the European Commission in its "Safety Features for medicinal products for human use. Questions and answers",(7) in which Question 1.20 states as follows:

If pack bearing the safety features is lawfully opened (e.g. by parallel traders/manufacturers replacing the leaflet under the supervision of national competent authorities), can it be resealed (e.g. by applying a new ATD on top of the old, broken ATD)?

The European Commission has answered this question affirmatively in principle, provided that the old anti-tampering device can be replaced with an equivalent. This is interpreted in the sense that the new anti-tampering device is, among other things, "equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products" (see also Article 79bis of the Belgian Royal Decree concerning medicines for human and veterinary use(8) and Article 1(8) of the EU Falsified Medicines Directive, inserting Article 47a into the EU Directive on the Community Code relating to Medicinal Products for Human Use (2001/83/EC)).

New anti-tampering devices will be considered effective when the following cumulative conditions are met:

• The new anti-tampering device must completely seal the packaging and cover any visible sign of the original, broken anti-tampering device.
• The replacement of an anti-tampering device is conducted in accordance with an applicable good manufacturing practice for medicinal products and is subject to supervision by the Federal Agency for Medicines and Health Products (FAMHP).
• The manufacturer placing the equivalent anti-tampering device has verified the authenticity of the unique identifier and the anti-tampering device's integrity on the original pack before breaking the anti-tampering device or opening the original pack.

When these conditions are met, no objective necessity to rebox the parallel imported product exists and the parallel trader will need to proceed with the less intrusive alternative of over-stickering the product and placing a new anti-tampering device on top of the original anti-tampering device. In other words, the objective necessity will continue to be case specific and the anti-tampering device used by the trademark holder on the original packaging can be relevant for determining whether reboxing would be objectively necessary. The Brussels Court of Appeal has been requested to rule on this question and is expected to do so in the course of 2019.

For further information on this topic please contact Kirian Claeyé or Laura Traest at ALTIUS by telephone (+32 2 426 1414) or email (kirian.claeye@altius.com or laura.traest@altius.com). The ALTIUS website can be accessed at www.altius.com.

Endnotes

(1) Defined by the EU Falsified Medicines Directive as a medicinal product that provides a false representation of its identity, source or history (see Article 1(c) of the directive, inserting Article 1.33 of EU Directive on the Community Code relating to Medicinal Products for Human Use (2001/83/EC).

(2) Act of 25 March 1964 on medicines, OJ 17 April 1964. The EU Falsified Medicines Directive was transposed by the Royal Decree of 19 September 2013 amending the Royal Decree of 14 December 2006 concerning medicines for human and veterinary use and the Act of 20 June 2013 amending the Act of 25 March 1964 on medicines.

(3) The Royal Decree of 14 December 2006 concerning medicines for human and veterinary use, OJ 22 December 2006, err 19 June 2007.

(4) See Article 6quinquies, 7th member of the Medicines Act.

(5) See also Article 6septies, Section 2 of the Medicines Act and Article 2.1(c) of EU Regulation 2016/161, referring to Article 54a(5) of the EU Directive on the Community Code relating to Medicinal Products for Human Use, which provides EU member states with the power to extend the scope of application of safety features.

(6) ECJ, 11 July 1996, C-427/93, Bristol-Myers Squibb.

(7) See https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/qa_safetyfeature_en.pdf, currently in its twelfth version (dated November 2018). This document will undoubtedly play a role in the practice of the FAMHP, as it is also accessible on FAMHP's website.

(8) This law will enter into force at a date to be determined by the Crown.