Michael Rooney is product supply manager at Almac.
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Although the European market is approximately 50% smaller than the US in terms of landmass, the population of Europe is approximately
50% larger and this presents a huge market opportunity. At our company, we have witnessed a steady increase in the number
of US companies taking advantage of European market opportunities, particularly for niche biopharmaceutical and orphan drug
products. In return, this has increased the outsourcing requirements for country specific-packaging and temperature-sensitive
distribution services. To meet this demand, we have increased investment in client dedicated cold and frozen storage and developed
a late-stage customisation suite for country specific packaging.
In addition to this, we have seen further growth across services in pharmaceutical development, commercial manufacture and
packaging. Client requirements for bespoke solutions for biopharmaceutical packaging and distribution, as well as traditional
toll manufacture of solid oral dosage forms (branded and generic) are also on the increase.
The challenges of the EU marketplace
The key challenges for a company launching drug product in the European marketplace can be summarised in three simple categories:
Regulatory and quality differentiations
Europe has different regulatory and quality requirements compared with the US. For instance, all products manufactured outside
of Europe must undergo EU import testing according to Directive 2001/83/EC Article 51 to ensure they are compliant with the
specifications outlined in the marketing authorisation application (MAA). Within Europe, all drug products must be released
onto the market by the Qualified Person (QP) to confirm that the product is fit for purpose and has been processed to cGMP
standards. These two requirements are unique to Europe, which is why client companies need to to ensure they select a CMO
with quality resources and regulatory knowledge and experience in this region.
Impact of multiple languages on packaging requirements
One of the biggest challenges to entering the European market is the multitude of languages, which results in a large number
of associated country-specific pack formats. Within the 27 member states of the EU, there are 150 regional and minority languages,
of which 23 are recognised working languages. Labelling and packaging needs to be in member state language, requiring design,
generation and management of all packaging components, including labels, Patient Information Leaflets (PILs) and cartons,
for example.
For our clients, regional (multilingual) packs coupled to the application of blue box (country specific detail) at our late-stage
labelling operation have proved a success. Applying country specific blue box information to the packaging commits a unit
of drug product to that particular market. Partnering with CMOs that provide late-stage customisation enables pharma companies
to benefit from flexible stock utilisation, resulting in the ability to be responsive to fluctuations in various market demands,
as well as to eliminate excess storage of stock.
