APPENDIX 118
Memorandum from the Pharma Documentation
Ring
1. EXECUTIVE
SUMMARY
1.1 The P-D-R represents 22 of the major
international pharmaceutical companies.
1.2 We contribute to the literature by
(1) prominent advertisements for our products in many journals
(2) sponsoring publication costs of supplements or special issues
(3) purchasing article reprints for use at medical or scientific
conferences or for answering other marketing enquiries. (4) publishing
a significant number of articles each year reporting the results
of our research and clinical trials.
1.3 Access to peer-reviewed, quality assured
scientific literature is essential for the continued success of
the pharmaceutical Industry in the UK, Europe and Internationally.
The ability to publish the results of our R&D activities,
and particularly the results of clinical trials our Companies
have conducted or sponsored, is also of critical importance. Clinical
opinion leaders and prescribers rely on peer-reviewed journals
for high quality, balanced information on new medical products
and treatments. Any change in the research publishing process
that might put this quality aspect at risk would be detrimental.
1.4 We have good relationships with most
of the major STM publishers; our member companies having negotiated
content licences with many of them. We are also testing new pricing
and access models with some of them.
1.5 As we move towards electronic collections
and away from print, we expect publisher price increases to be
closer to prevailing inflation rates than we have seen in the
recent past. If this does not happen, then it is likely that these
cost factors will restrict access to the research literature for
our users.
1.6 The new Open Access publishing initiatives
are welcomed by the P-D-R, but we would not want to see the abandonment
of the current system to one that is as yet untested, particularly
in terms of its ability to deliver high quality published research.
1.7 Another critical aspect of Open Access
is that of reliable access and a long-term dependable archive.
The National Library should have a role with the latter.
2. WHAT IS
THE P-D-R ?
URL: http://www.p-d-r.com
2.1 The P-D-R is today an organisation of
corporate representatives from 22 of the major international pharmaceutical
companies. Representatives must belong to the scientific, biomedical
or technical information functions of a research-based pharmaceutical
company and be able to report on non-confidential aspects of the
information science activities of the corporate group.
2.2 The aim of the P-D-R is to attain improved
coverage, better distribution and optimum use of chemical, biomedical
and pharmaceutical information. This aim is achieved by promoting
exchange of experience and ideas between members in non-confidential
areas of work and by jointly studying and assessing existing information
products and services for the purpose of improvement.
2.3 The P-D-R also initiates and encourages
the development of new information services tailored to the needs
of the pharmaceutical industry and provides a forum for the information
industry serving the pharmaceutical sector.
2.4 Over the past decade with the growing
availability of electronic journals, P-D-R has established a collaboration
with publishers' organisations like the PA (Publishers Association),
STM (International Association of Scientific Technical and Medical
publishers) and ALPSP (Association of Learned and Professional
Society Publishers) addressing the needs of the corporate sector
and the special needs of the pharmaceutical sector.
One of the achievements of this collaboration
was the creation and general acceptance of the STM/P-D-R Sample
e-Journal Licence ( http://www.p-d-r.com/Licence/STM PDR/stm pdr.html
). Another ongoing initiative is the creation of a Code of Practice
for publishers' provision and Pharmaceutical companies' use of,
e-content .
3. THE USE
OF SCIENTIFIC
PUBLICATIONS IN
THE PHARMACEUTICAL
INDUSTRY
3.1 One of the reasons for the productivity
and success of the pharmaceutical Industry in the UK, Europe and
Internationally is that our staff have access to high quality
published information. This comes mainly from the peer reviewed
output from commercial and Society publishers.
3.2 Staff use this information, together
with that from other sources, to follow new leads, investigate
new procedures and monitor competitor's products and developments.
New drugs, new cures against diseases can only be successfully
and efficiently developed when the present scientific knowledge
is easily available and reliable. The development of a new drug
can take up to 12 years and costs up to 800 million Euros. Scientific
publications are a key resource for pharmaceutical research.
3.3 The future success of this industry
depends on the continuing supply of this high quality information.
We depend on publications that are scientifically accurate, validated
by peer-review, and quality assured through careful copy-editing
by the publisher. We would be concerned if any change in the research
publishing process puts this quality aspect at risk.
4. LICENSING
AND RELATIONSHIP
WITH PUBLISHERS
4.1 The pharmaceutical market has always
been an important one for many publishers. Not only have we subscribed
to multiple copies of some journal titles (due to our multi-country,
multi-site organisations) but we have paid premium commercial
institutional rates for these titles. With more than 6m scientific
papers published annually, the pharmaceutical industry particularly
values the efforts of publishers in making scientific knowledge
efficiently searchable and accessible.
4.2 The pharmaceutical industry is a major
contributor to many journals in four other ways. Firstly, we place
prominent advertisements for our products in many journals, especially
medical and clinical titles. Secondly, we may sponsor the publication
costs of supplements or special issues in journals that publish
in therapeutic areas in which we have a specific interest. Thirdly,
we purchase many thousands of article reprints from publishers
for use at medical or scientific conferences or for answering
other marketing enquiries. Lastly, we publish a significant number
of articles each year reporting the results of our research and
clinical trials
4.3 In the days before online versions of
journals, we had little or no contact with publishers, placing
all our orders through subscription agents. As online versions
became available, it became clear that we required more extensive
usage rights than the publishers were providing in their standard
licences. For example we needed to be able to distribute articles
freely and without restriction within our global companies, and
to use the licensed content for Regulatory submissions work.
4.4 Therefore most of the global pharmaceutical
companies have now negotiated and licensed directly with the major
publishers for online access. Initially this was for the journals
that the pharmaceutical companies subscribed to in print, but
increasingly we have looked at extending the range of titles available
to our users, by licensing additional titles from some publishers.
(The so-called "Big Deal") This has been justified entirely
on a cost-benefit basis for each deal. There has been no question
of us being forced into choosing these collections, though it
has resulted in us have access to journals that are of marginal
or no interest..
4.5 Because of the availability of online
journals and our ability to license these, our staff now have
access to more journal titles than they previously had access
to in print. Our licences cost more than we used to pay for the
print alone, but the advantages of instant access when and where
required, helps to meet our business needs and can be cost-justified
when that additional cost is proportional to the local inflation
rate index.
4.6 We now have closer working relationships
with publishers than ever before. This has been beneficial to
both parties. Publishers understand our particular usage requirements
and expectations for service, whilst we have been able to assist
publishers with new product development, and developing new pricing
policies. We also serve on many publishers' Library Advisory Boards.
4.7 The Pharmaceutical Industry has also
worked through their own industry bodies with Reproduction Rights
Organisations such as the Copyright Clearance Center (in the US)
and the Copyright Licensing Agency (in the UK) to develop blanket
copying licences that meet the needs of our industry. We are recognised
as a highly copyright compliant industry.
4.8 We expect online journal access models
and pricing models to change. We cannot base future pricing models
for online access on what that company used to take in print years
before. We have been working with publishers in this area and
are currently testing several new pricing models based on collecting
and analysing usage metrics and basing the licence price on this.
5. PHARMACEUTICAL
STAFF AS
AUTHORS
5.1 Much of the R&D carried out in our
industry is commercially sensitive, and therefore the results
may not be published externally.
5.2 But our industry also needs to communicate
new information on its products to clinical opinion leaders and
prescribers. Peer reviewed journals play an important role in
ensuring that timely, balanced and high quality information is
available to opinion leaders and prescribers. As a result, the
pharmaceutical industry publishes a significant number of articles
each year.
5.3 As with any other author, the publishers
may require that copyright of the article to be published be transferred
to them. Some publishers grant back to the author or their employer
certain rights eg the right to continue to use the article internally
within their organisation. In other cases, we need to buy back
the results of our own research at publishers' prices. Any use
of a published article for commercial purposes, eg promotional
purposes at a conference, invariably involves the purchase of
reprints from the publisher. The Pharmaceutical Industry recognises
that the sale of reprints is an important source of revenue for
STM publishers and is prepared to continue with this arrangement.
Some of our companies are now asking that our authors do not assign
their copyright to the publisher in this way, and that we retain
full rights and control over our published research, but most
publishers will then refuse to publish the article.
6. OPEN ACCESS
: IMPLICATIONS FOR
THE PHARMACEUTICAL
INDUSTRY
6.1 P-D-R companies have been challenged
over the last few years by the significantly increasing journal
costs and the additional costs for electronic access. Heavy price
increases, however, are not only experienced with commercial publishers
but also with publishing houses owned by scientific societies.
The P-D-R welcomes the move to electronic access. Some member
companies have already switched their collections to e-only. While
there is willingness to pay for this new access route and also
acceptance that industrial customers pay higher license fees than
academia, continuing annual price increases in the double digit
range are not acceptable. The continuing price increases coupled
to budgetary pressures within our industry have resulted in the
cancellation of some print subscriptions even to well-known and
prestigious STM journals. Subsequently, dissemination of information
and knowledge is reduced, and the intrinsic reason for scientific
publishing is neglected.
6.2 In this context a broader competition
through the new Open Access journals is welcomed by the pharmaceutical
industry, hoping that this helps to limit the cost increase. But
as mentioned before, keeping the quality control and quality assurance
on a very high level is extremely important and the new Open Access
journals still have to prove, that this is done in the same way
as traditional high impact factor journals .
6.3 The P-D-R companies may be reluctant
to publish in these new OA journals whilst they are still establishing
themselves and the Impact Factors are low. It is commercially
important for us to publish our work in those journals that are
likely to be read by the key opinion leaders and prescribers.
6.4 The archiving and access issues seem
to be the critical aspects with Open Access publishing. With the
move from print to electronic resources, libraries often abolished
their print holdings and solely depend on the publishers archives.
Therefore, an assured archive and assured, easy and standardised
access to that archive is absolutely necessary. While traditional
publishers, so far, have proved to be able to provide this, the
economical background of some Open Access publishers leaves doubts.
We would expect the Legal Deposit libraries to also have a role
in providing long-term access to this archive.
6.5 One Open Access initiative that is a
strongly supported by the P-D-R is where the publisher makes the
journal archive freely available to everyone a short time after
publication. This may be as short as three months, or up to a
year after publication. We might subscribe to these in order to
get the most recent content which is of the most value to us,
but non-subscribers then get access a short time later.
6.6 A shift of budget from the library to
the author's functions in R&D, an inevitable consequence of
the shift to open access publishing, is not a major problem for
pharmaceutical companies. It would also simplify the current processes
for making a companies' own publications easily available on their
websites by linking to the Open Access article. However, mandatory
use of Open Access journals is not a realistic alternative from
our perspective.
6.7 The current publishing system has served
us well in recent years as we have moved towards electronic journals
and away from print. We have worked with most of the STM publishers,
large and small, to facilitate this transition. The worst scenario
from our perspective would be the abandonment of this system to
one that is as yet untested, particularly in terms of its ability
to deliver high quality published research.
6.8 Finally, we have indicated in this submission
that the P-D-R member companies, despite publishing some research
themselves, are net consumers of research information. So if OA
were to become the dominant publishing model, it could be said
that we would benefit the most in terms of cost savings. We would
like to confirm our commitment to the continuation of a high quality
peer reviewed publishing process. We would not want to do anything
that jeopardises this. Therefore we would be quite open to discuss
future funding models with OA publishers. One model could possibly
be sponsorship from pharmaceutical companies. The detail would
have to be worked out, so that there could be no possibility of
us being perceived as sponsoring certain articles or research,
but it is an area we are open to explore further with the relevant
parties.
7. RESPONSES
TO SPECIFIC
QUESTIONS ASKED
BY THE
ENQUIRY
Many of these responses are also made in the
main part of our submission, but are repeated here for convenience.
7.1 What impact do publishers' current policies
on pricing and provision of scientific journals, particularly
"big deal schemes", have on libraries and the teaching
and research communities they serve?
P-D-R companies have been challenged over the
last few years by the significantly increasing journal costs and
the additional costs for electronic access. Heavy price increases,
however, are not only experienced with commercial publishers but
also with publishing houses owned by scientific societies. The
P-D-R welcomes the move to electronic access.
Continuing annual price increases in the double
digit range are not acceptable and can only result in the cancelling
of further journal subscriptions within our industry. Early notification
of price increases improves our ability to budget appropriately.
Increasingly we have looked at extending the
range of titles available to our users, by licensing additional
titles from some publishers. (The so-called `Big Deal' ) This
has been justified entirely on a cost-benefit basis for each deal.
There has been no question of us being forced into choosing these
collections.
7.2 What action should Government, academic
institutions and publishers be taking to promote a competitive
market in scientific publications?
In a sense there is no competition because,
for example, if we want to buy Nature, we can't buy that from
anyone else but Nature. In a sense, the most prestigious journals
are monopolies. They can name their price and we will continue
to subscribe to them. We rely on them adopting a responsible approach
to pricing.
But we would support any Government initiative
that encourages the principles of freedom to publish in high quality
journals, whether they be Open Access or commercial journals.
7.3 What are the consequences of increasing
numbers of open-access journals, for example for the operation
of the Research Assessment Exercise and other selection processes?
Should the Government support such a trend and, if so, how?
This is a matter for those directly involved
to consider.
7.4 How effectively are the Legal Deposit
Libraries making available non-print scientific publications to
the research community, and what steps should they be taking in
this respect?
If a publisher ceases to provide online access
to a particular journal that we had licensed, we would expect
the National Library to take over that access, in order to secure
the long-term availability of that title.
For non-subscribed journals, we would expect
the National Library to provide electronic access to these journals
on a buy-as-needed basis, to include any fee due under local copyright
regulations.
7.5 What impact will trends in academic journal
publishing have on the risks of scientific fraud and malpractice?
If OA journals are refereed to the same high
standards as traditional journals are now, then the risk of fraud
should be no more. The danger is that if OA publishers are tempted
to accept more papers than a traditional publisher might (because
the author is paying, hence an increase in revenue for the publisher)
then the peer review process may come under strain, standards
might drop and the risk of fraudulent research being published
might increase.
April 2004
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