Regulatory Focus™ > News Articles > 'Small Pharma' has Big Impact on Pharmaceutical Ecosystem, EMA Finds

'Small Pharma' has Big Impact on Pharmaceutical Ecosystem, EMA Finds

Posted 04 February 2014 | By Alexander Gaffney, RAC

When most laypersons-and by that, we mean people outside of industry-think about drug development and drug approvals, one of the terms most synonymous with the process is "Big Pharma." Big companies with big budgets and big influence over the drug process want approvals so they can make money by marketing to big patient populations.

Or so the popular thinking goes.

But as new data from the European Medicines Agency (EMA) illustrates, that's a view which is often false.

In fact, 27% of all innovative medicines brought to market in the EU between 2010 and 2012 originated from small or medium-sized enterprises (SMEs), EMA said, citing new research data compiled by its regulators. Those companies are defined as having fewer than 250 persons and annual revenues of less than €50 million.

To put it more bluntly, it's not always "Big Pharma" with drugs before regulators. Sometimes it's Small Pharma.

The Impact of Small Pharma

Large companies were also not fully responsible for another 17% of applications, which originated with academic institutions, public bodies and public-private partnerships. EMA notes that most of these companies developed the medicines, but did not submit marketing applications on behalf of their drugs directly. Instead, many drugs are licensed to larger companies with experience in drug submissions.

The findings came from a review by regulators, who looked at all new active substance approvals by EMA between 2010 and 2012, and then analyzed the profile of each respective developer of the medication.

There may, however, be some accuracy in the "Big Pharma" motif. While SMEs accounted for 27% of all new active substances, they disproportionately developed medications for orphan designations (61% of all orphan drugs). That means that when it comes to drugs most people took, they were more likely to have taken something developed by a larger "Big Pharma" company.

So why does this matter?

"Understanding the factors that could affect drug innovation, such as the nature of the organizations involved, could help in developing strategies to catalyze further advances," explained EMA regulators in research published in the journal Nature. "This analysis shows that SMEs, academic institutions, public bodies and public-private partnerships represent an important source of innovation and bolster the product pipelines of larger companies."

By providing specialized support-scientific advice, for example-to smaller companies, EMA may be able to better enable development of new drugs by SMEs and other smaller actors within the "pharmaceutical innovation institution, particularly academia," regulators wrote.


EMA Statement

Nature Research

Tags: EU

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