[Ip-health] BMJ: More drugs originate outside the industry than it claims

Thiru Balasubramaniam thiru at keionline.org
Mon Feb 24 03:49:35 PST 2014

      1. http://www.bmj.com/content/348/bmj.g1354
      3. NEWS
      More drugs originate outside the industry than it claims
      2. Jacqui Young

Many innovative drugs, especially to treat rare diseases, originate not
from large drug companies but from small enterprises or academia, a new
study has shown.

The research by the European Medicines Agency shows that 44% of innovative
drugs recommended for marketing authorisation in the European Union
originated from small or medium sized enterprises, academia, public bodies,
and public-private

This seems to contradict the claim by Stephen Whitehead, chief executive of
the Association of the British Pharmaceutical Industry, that the industry
was responsible for developing 90% of the drugs available to

The study, published in *Nature Reviews Drug Discovery*, identified all the
drugs containing a new active substance that were recommended for marketing
authorisation between 2010 and 2012 by the European Medicines Agency’s
Committee for Medicinal Products for Human Use. The researchers identified
94 drugs, of which 18 were “orphan” drugs developed to treat rare diseases.

When the researchers tracked the products back through development to their
origin, they found that large or intermediate sized drug companies
accounted for 49% of the drugs. Another 27% originated from small or medium
enterprises and 17% from academic institutions, public bodies, and
public-private partnerships. Private-private collaborations accounted for
7% of the products.

The researchers found that 61% of orphan drugs originated from small or
medium sized enterprises, even though these organisations held the
marketing authorisation in only a fifth of cases. The study also found that
11% of orphan drugs originated from academic institutions, public bodies,
and public-private partnerships, although these organisations were no
longer involved at the stage of application for marketing authorisation.

The researchers wrote, “Overall, although large and intermediate-sized
companies still represent the main engine for commercializing new
medicines, SMEs [small and medium sized enterprises], academic
institutions, public bodies and PPPs [public-private partnerships]
represent an important source of innovation and enrich the product
pipelines of larger companies.”

The agency said that it had a programme in place to support small and
medium enterprises throughout all stages of drug development so as to
promote the emergence of innovative drugs.

The study also found that 45% of the original research leading to the
products occurred in North America and 37% in Europe. International
projects, mostly transatlantic collaborations, accounted for 8%, and other
countries (such as Japan, China, Israel, and Australia) accounted for the
remaining 10%.

Iain Chalmers, one of the founders of the Cochrane Collaboration and
coordinator of the James Lind Initiative, said, “The chief executive of the
ABPI [Association of the British Pharmaceutical Industry] has claimed more
than once that 90% of new drugs come from industry, but he doesn’t provide
evidence to support this claim. He appears to overlook the substantial
contribution of publicly funded university departments which have made the
discoveries that have led to new drugs.”

*Cite this as:* *BMJ* 2014;348:g1354

   1. ↵ <http://www.bmj.com/content/348/bmj.g1354#xref-ref-1-1>
   Lincker H, Ziogas C, Carr M, Porta N, Eichler H. Regulatory watch: where
   do new medicines originate from in the EU? Nat Rev Drug Discov 31 Jan
   2014, doi:10.1038/nrd4232 <http://dx.doi.org/10.1038/nrd4232>.
   2. ↵ <http://www.bmj.com/content/348/bmj.g1354#xref-ref-2-1>
   Whitehead S. Transparency in pharma and healthcare [blog].

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