But some of the key outcomes of the Directive are already in place, including that labels must be in the local language (although
the labeling system has been harmonized); the standardization of application forms; and the introduction of free movement
of materials between the United States or Japan and Central and Eastern Europe (CEE). And it is now illegal to start a clinical
trial unless an ethics committee has consented, the MHRA has licensed the trial, and the sponsor has been declared. This, however, does not necessarily mean that conducting clinical trials in Europe is easier than before. Despite the attempt
to create a unified clinical trial regulatory framework throughout the EU, there remains differences in practice. One company
that exports abroad told us that there are still headaches regarding import licenses for Eastern Europe, but these problems
are decreasing. For instance, Poland still requires the submission of a signed contract, whereas usually a template is sufficient
in other countries. Such local variations inevitably demand more corporate resources. Furthermore, the regulatory framework put forward by the EU is often far more rigorous than national ones. Consequently, as
we discovered in our interviews with companies, the Europe-wide implementation of the Directive has inevitably made conducting
clinical trials a more costly exercise in terms of time and financial investment. But despite these obstacles, companies generally
subscribe to the view that the ever-increasing degree of harmonization will ultimately make it easier for them to engage in
clinical trials. 
Creation of Hybrid Logistics Models
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There seems to be a degree of consensus throughout the clinical trial industry on two points. One, that there is an increased
emphasis on niche drugs, and therefore clinical trials require specialist centers that have expertise in the specific clinical
area. And two, that the increase in the variety of drugs in trials creates demand for a wider opinion leader base, and the
expansion of the EU gives rise to multicenter clinical trials that are conducted in multiple countries.
These two issues create a larger role for logistics companies to coordinate between multicenter sites and expand the complexity
of conducting a clinical trial. We found evidence that the industry structure is making a corresponding change. For example,
Quintiles used to operate as a one-stop shop; however, the increasing complexity of the underlying market meant that sponsors
had to deal with different people at each step. This undermined the point of only having to deal with one company. So, they've
since sold off their packaging division and moved away from this model. Pfizer also depends on outsourcing, having downsized
its in-house capabilities. While the clinical trial industry is constantly reforming itself, we have identified three main trends:
- An expansion of clinical trials into new markets in CEE
- Increasingly complex services provided by discrete units in the clinical trial value chain
- Entirely new hybrid logistics business model that provides linkages between the entire value chain.
New markets One doesn't need to travel to Eastern Europe to detect the emerging trend of the region. According to a company based entirely
in the UK, the proportions of the materials that they package that remain in the UK are "tiny." Roughly 50% are shipped elsewhere
in Europe and 50% to the rest of world. In terms of breaking down the EU market into separate areas, this is problematic for several reasons. Many of the major CROs
are U.S.-based and only consider global trends since business units define revenue in different ways (making it hard to compare
like with like). And if they are a public company, their attention is on the share price, which is a global value. Also, since
trials span multiple countries, there is no meaningful difference in growth rates throughout each region—that is, we can infer
the Czech growth rate from CEE, given the population size and therefore availability of patients.
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