role of the pharmaceutical industry
1. In the 20th century, humankind
underwent the most spectacular medical advances in its history. Scientific
progress helped us to identify the origin of countless illnesses,
some of which had previously been incurable, and to discover vaccines
and effective medicinal treatments to prevent and cure them. Inevitably, these
advances led to improvements in the quality of life and the life
expectancy of millions of people.
The rise of the pharmaceutical industry coincided with this
scientific boom period, during which the major laboratories, working
with academies and universities, invested massively in the research
and development of new medicines. Today, the industry is one of
the key players in public health and one of the most powerful and lucrative
economic sectors in the world.
dual public-private role requires a healthy balance to be maintained
between the legitimate commercial interests of the pharmaceutical
industry and public health interests, bearing in mind that they
do not necessarily correspond. This, moreover, is the underlying
philosophy of this report, which upholds the principle that in no
circumstances should the private interests of the pharmaceutical
industry interfere with public health interests. This places a requirement
on us, as politicians, to keep a close eye on the activities of
3. On this basis, it was initially planned to consider mainly
the interaction between the pharmaceutical industry and various
players in the field of health, so as to examine the possible conflicts
of interest and the biased decisions likely to result. However,
it quickly became clear that medicines research and development (R&D)
by the pharmaceutical industry deserved just as much, if not more
attention, because of their implications for public health, particularly
as regards the accessibility of medicines.
In the drafting process of
the report, it seemed vital to me to meet the main players concerned
in order to gather information at first hand and to ascertain their
viewpoint on the issues of concern to us. To this end, I made two
fact-finding visits, the first to Geneva (Switzerland) on 19 and
20 November 2014, and the second to London (United Kingdom) on 26
and 27 February 2015. In Geneva, I had talks with representatives
of the World Health Organization (WHO), the International Federation
of Pharmaceutical Manufacturers and Associations (IFPMA), a biotechnology
company (Geneva Biotech Center) and the non-governmental organisation
(NGO) Bern Declaration (DB).
In London, I had talks with representatives
of the European Medicines Agency (EMA),
the International Alliance of Patients’
Organisations (IAPO) and Health Action International (HAI).
5. Following the same line of thinking, the Committee on Social
Affairs, Health and Sustainable Development held a public hearing
on 24 June 2014, with the participation of Mr Peter Beyer, Senior
Advisor in the Essential Medicines and Health Products Department
of WHO, Mr François Bouvy, Director in the Market Access Department
of the European Federation of Pharmaceutical Industries and Associations
(EFPIA), and Mr Patrick Durisch, Health Programme Co-ordinator at
DB. At this hearing, the committee focused mainly on R&D and
the accessibility of medicines. I should like to thank all the parties
to whom we spoke for making themselves available and providing us
with valuable information.
2. Interaction between the pharmaceutical
industry and the various players in the health field
6. Initially, I should like to
concentrate on the pharmaceutical industry’s interaction with the
various players in the health field, and analyse whether, and if
so to what extent, that interaction is likely to influence the knowledge,
attitudes and behaviour of the players concerned and to give rise
to biased decisions or practices which are not in the interest of
7. Today, interaction between
the pharmaceutical industry and the different players in the health
field is ubiquitous: it exists at every level of the medical system,
from research to consumer, and involves all its players, including
universities, hospitals, doctors, nurses, pharmacists, scientific
publishers, health authorities, health insurance funds and patients’
8. In the case of health-care professionals, especially doctors,
nurses and pharmacists, that interaction often starts at an early
stage, as soon as their medical studies begin, and continues throughout
their career. The increasing dependence of research and medical
training on the pharmaceutical industry makes such interaction inevitable.
In this context, it may be noted, for example, that the industry
organises and sponsors the great majority of symposia, congresses
and seminars – which are regarded as vocational training – which it
often invites researchers and health professionals to address (for
which they are paid). Those congresses are also, for doctors and
researchers, an opportunity to join pharmaceutical firms’ advisory
boards. Similarly, the medical sales representatives systematically
promote medicines to doctors, as well as pharmacists.
9. In the case of health authorities, for example medicines agencies,
it is the very nature of the relationship that makes interaction
ubiquitous. In fact, in order to obtain marketing authorisation
for its medicines, the pharmaceutical industry has to submit a file
to those agencies. In this context, the industry’s interaction with experts
working for these agencies is an important factor to be taken into
account as experts often have linked interests with the industry.
10. A third case is that of patients’ associations. These associations
play a fundamental role in patients’ lives, providing them and their
families with psychological, practical, financial, social and legal
assistance. They also have strong lobbying power. The pharmaceutical
industry makes a considerable contribution to the funding of these
associations, in return for which it enjoys certain advantages.
Taking the IAPO as an example, those advantages are determined by
the level of financial support given by each of the pharmaceutical companies
termed “Industry Partners”. Those partners are divided into three
categories (gold, silver and bronze) enjoying advantages ranging
from expressions of gratitude for their financial contribution on
IAPO’s website to bilateral meetings with Alliance representatives.
IAPO considers the industry to be a significant source of information.
The interaction briefly described above is legitimate, necessary
and valuable. These are natural partnerships based on common interests
bringing mutual benefits and important collaboration for innovation and
public health. It is not a question of challenging the very principle
of this interaction. Rather it is about whether, in the absence
of any appropriate regulatory framework, this interaction could
have adverse effects with serious implications for public health.
In my view, one merely has to look at the example of the Mediator case
in France to realise that the answer to this question is unfortunately
a resounding “yes”. This case highlights the dangerous collusion
between health authorities and pharmaceutical companies, in which
the malfunctions were due, amongst other reasons, to the conflicts
of interests of certain experts.
do conflicts of interest begin?
12. What is common to all the interaction
mentioned above is that they create a link between the interests of
the pharmaceutical industry and those of the players concerned.
Linked interests, of course, are not the same as a conflict of interest.
Political science Professor Dennis Thompson, from Harvard University,
gave the following definition of a conflict of interest: “A set
of conditions in which professional judgment concerning a primary
interest (such as patients’ welfare or the validity of research)
tends to be unduly influenced by a secondary interest (such as financial
gain).” Accordingly, a link between interests is not in itself awkward,
but entails the risk of a slide into problematic behaviour if the
secondary interest prevails over the primary one. But it is not
an easy matter to determine where conflicts of interest begin.
13. In the case of doctors, for instance, the daily presence of
the industry by their side creates both links and trust. These come
to be regarded as normal, even routine, and the risks that may ensue
from such apparently inoffensive interaction are underestimated.
Indeed, health professionals often believe that product promotion does
not influence them. They have little awareness of the influence
of promotional activity, which is more effective than they imagine.
Health professionals commonly take the view that “promotional activity
has no effect on me”.
Yet the pharmaceutical industry’s marketing activities result
in sales because they are able to influence health professionals’
decision-making process, and therefore the prescription and supply
For example, studies
have shown that doctors are more likely to prescribe medicines that
have been promoted to them by pharmaceutical companies, and not
necessarily for the right reasons. This can at times result in the irrational
prescribing of medicines, with harmful effects not only for patients,
but also for the budgets of health systems which have to reimburse
the cost of those medicines.
With regard to the health authorities, there have been recurring
criticism in connection with the problem of conflicts of interest
among experts working with these authorities. In the case of the
EMA, for example, the scientific evaluation system operates through
a network of external experts. Those experts serve as members of
the Agency’s scientific committees, working parties or scientific
evaluation teams. In 2012, the audit report by the European Court
of Auditors on the management of conflicts of interest within four European
Union agencies, including the EMA, concluded that “none of the selected
Agencies adequately manages conflict of interest situations”. At
the end of November 2014, the EMA announced the adoption of a more
balanced policy on managing conflicts of interest, which came into
effect on 30 January 2015.
The case of patients’ associations is particularly sensitive.
Most of them very much depend on the industry for their funding.
They seem well aware of the danger that this dependency may create,
potentially going as far as manipulation by the industry. Indeed,
the pharmaceutical industry has been accused of attempting to mobilise
patients to lobby against the revision of the European Directive
on clinical trials regarding certain proposals advocating the transparency
of such trials
using patients’ associations to bypass the ban on direct advertising
to consumers of prescription drugs.
and management of conflicts of interest
There is a wide range of rules
governing interaction between the pharmaceutical industry and the different
players in the health field, the aim of which is to ensure the transparency
of relations and avoid conflicts of interest which may occur as
A major proportion of those
rules comprises non-binding texts, such as principles or codes of
good practice drawn up by the pharmaceutical industry itself (self-regulation).
The IFPMA Code of Practice is a good example of self-regulation.
It includes rules on ethical promotion of medicines to health professionals
and ensures that interaction with health professionals and other stakeholders,
such as patients’ organisations, is appropriate and perceived as
such. Membership of the IFPMA requires the associations concerned
to comply with the ethical standards laid down in it. The Code provides
for a monitoring mechanism whereby genuine complaints about infringements
thereof are encouraged. The IFPMA may handle such complaints, on
condition, inter alia
the alleged infringement is not already the subject of an investigation
by one of the member associations. The decision is taken by an ad
hoc group of persons experienced in the application of national
codes and selected from IFPMA member associations. To date, the
IFPMA has dealt with three complaints.
The EFPIA also has codes of good practice covering interaction
with health-care professionals and patients’ associations. In addition,
it has recently embarked upon a series of initiatives to enhance
the transparency of the pharmaceutical industry. One of these initiatives
will result in EFPIA member companies publishing, with effect from
2016, their financial relationships with health-care professionals
20. The new EMA policy on managing conflicts of interest (see
paragraph 15) evaluates conflicts of interest according to the different
types (direct/indirect) and levels of interest (level 1, 2 or 3).
The restrictions are applied on the basis of the nature of the interest,
the time that has elapsed since the interest and the type of activity
concerned within the EMA.
It remains to be seen whether this wide range of instruments
is truly effective in preventing and managing conflicts of interest.
Self-regulation demonstrates the commitment of the industry to adopt
a more ethical approach, which is undoubtedly laudable, but in my
view it is inconceivable to be content merely with self-regulation
in such a sensitive field as public health.
this is not binding and, therefore, not dissuasive. The HAI representatives
told me that national legislation and European regulations were
often too lenient and that their implementation left much to be
What is more, there seems to me to be a degree of confusion
between transparency and the management of conflicts of interest.
In practice, financial or other interests are now to a greater or
lesser extent systematically declared by experts, doctors, etc.,
and in certain countries these declarations may be viewed on line.
the fact of transparency does not in itself solve the problem of
conflicts of interest. First of all, how can we be sure that declarations
are full and reflect the facts? When we put the question to the
representatives of the EMA, they replied, with good reason, that
it was quite simply impossible for them to investigate every expert.
Second, who is to manage all these declarations and how is this
to be achieved if conflicts are to be avoided? Without any appropriate
response to these questions, there is the risk that we shall reach
a point where too much transparency will end up killing transparency.
can we be more effective in preventing and managing conflicts of
23. I realise that excessively
strict regulations totally severing links between the industry and
the health sector players would hardly be feasible, or even desirable.
However, other less radical solutions are possible.
In Resolution 1749
“Handling of the H1N1 pandemic: more transparency needed”,
the Parliamentary Assembly had expressed its concerns about the
lack of transparency in decision-making processes linked to the
pandemic and the risk of conflicts of interest between experts involved
in sensitive decision-making on health matters. It had put forward
specific recommendations for health authorities, calling for the
publication, without exception, of the declarations of interest
of the experts concerned and for all persons subject to a potential
conflict of interest to be excluded from sensitive decision-making
processes. I believe that these recommendations are totally relevant
to the questions that concern us in this report. In addition, strict measures
should prevent a revolving door policy, namely the movement from
a position in the public sector to one in the private sector, in
other words between the health authorities and the pharmaceutical
industry which they are supposed to regulate and monitor.
25. Bearing in mind the adverse effects of promotion activities
on doctors, one might wonder if they should simply be banned. This
is undoubtedly a legitimate question, but I would suggest a more
pragmatic measure: introducing a mandatory levy on promotion activities
to finance a public fund to be used for the independent training
of health-care professionals and independent research. This type
of funding already exists in some European countries, such as Italy.
In fact, since 2005 each year, pharmaceutical companies have paid
the Italian Medicines Agency (AIFA) a sum equivalent to 5% of the
total amount spent on promotion activities. Such a measure could
also encourage pharmaceutical companies to reduce their advertising
expenditure, which would kill two birds with one stone.
26. Moreover, it is absolutely essential to overcome the reluctance
of health-care professionals to accept that they are indeed susceptible
to promotion, right from the very start of their training. Specific
training to foster greater awareness of the influence of pharmaceutical
promotion and how to respond should therefore be included as a mandatory
aspect of the university curriculum of health-care professionals.
In addition, as far as possible, their vocational training should
be financed by public funds.
27. With regard to the funding of patients’ associations, first
the financing received from public funds should be increased, and
second, thought should be given to setting up a joint fund to help
finance them. Pharmaceutical companies could contribute to this
joint fund, the management of which should be entrusted to an independent
authority. This would enable the industry and the associations to
continue their collaboration, while giving the latter greater independence.
research and development by the pharmaceutical industry
Research and development for
new therapeutic molecules is a costly and lengthy process.
return for this significant investment in terms of both time and
money, pharmaceutical companies benefit from an intellectual property
right to the molecules that they develop, protected by a patent.
During a limited period, generally comprising between 15 and 20
years, no company may copy the molecules concerned. Once that period
is over, their formulation comes into the public domain, and “generic
products” may be brought to the market.
29. It follows that the model of pharmaceutical innovation is
based on a system of patents which enables the industry to retain
the monopoly over its products for a limited period of time, negotiate
their prices without being subject to competition and in this way
gain a return on its investment. This system is considered necessary,
if not vital, for creating incentives for the pharmaceutical industry
to invest in R&D for new medicines. Indeed, the major pharmaceutical
laboratories explain that the funding of R&D for new molecules
is extremely costly, and that only the system of patents can offset
30. While the system described above has enabled thousands of
medicines to be discovered which have brought about outstanding
improvements in public health, its efficiency is increasingly called
into question today, in terms of both pharmaceutical innovation
and economic sustainability.
of the pharmaceutical innovation process
In Europe, there is a growing
number of new medicines being introduced and spending on R&D
in the pharmaceutical sector has more than tripled since 1990. It
may therefore seem absurd to speak of an erosion of pharmaceutical
innovation, except that innovation must not be measured solely in
terms of the number of medicines placed on the market, but above
all in terms of medicines that present a real therapeutic benefit
and which satisfy real needs. If we use this as our definition,
there have been very few breakthroughs in terms of pharmaceutical
innovation in the past 10 to 20 years. Of the 20 or 30 new medicines
brought onto the market every year, only three may be truly new,
with the rest offering only marginal benefits.
A study published
in the magazine Prescrire
that of the 1 345 new medicines placed on the market between 2000
and 2013, 51% provided nothing new and only 2% presented a real
There are several reasons for this, including the pharmaceutical
sector’s business model. Fundamentally, this model used to be dominated
by a “blockbuster”
ensuring high profitability while enabling R&D costs to be recouped
through high sales levels. Thus the main aim of R&D was to perfect blockbusters.
As the patent on many blockbusters expired, the industry was subjected
to competition from generics, while at the same time facing the
problem of bringing new blockbusters to the market, inter alia
because of the rapid
growth of a more personalised medicine, more targeted at a group
of persons who respond better to the molecule offered.
order to maintain high profit levels,
the industry had to adapt and review its
business model. Critics say that today this is based on aggressive
promotion and meagre innovation.
In practice, in terms of R&D, the industry has started
to take fewer risks, outsourcing in some cases and purchasing from
molecules which have
reached more advanced stages, so are more expensive but have greater
chances of success. Furthermore, it has placed onto the market a
large number of second-generation medicines, which are new variants
of old molecules whose patent has expired, released in a slightly
modified form (“me-too drugs”).
Critics claim that
this enables the industry to file new patents and in this way protect
themselves against competition from generic medicines.
In terms of promotion, the industry
has invested on a massive scale in order to boost its sales, with
the large pharmaceuticals’ advertising expenditure now accounting
for up to twice what they are spending on R&D for new treatments.
prices of medicines
34. For several years now, there
has been an upsurge in the price of medicines. Between 2000 and
2009, public expenditure on medicines rose on average by 76% in
the European Union and the increase in expenditure on patented medicines
exceeded the savings made through the promotion of generic use.
Cancer drugs are among the medicines whose price is increasing
at an untenable rate, thereby threatening not only access by cancer
patients to these treatments, but also the sustainability of health
systems in general on account of the costs they generate.
However, the most
telling example is that of Sovaldi, a treatment for Hepatitis C.
In 2014, the US company Gilead introduced this treatment costing
60 000 Swiss francs for a 12-week course of treatment, equivalent
to almost 1 000 francs per tablet. Switzerland placed it on the
list of specialities for which costs are met by compulsory health
insurance, but with restrictions on its use. Consequently, only
those patients who already have cirrhosis of the liver – so barely
2% of patients – may claim reimbursement, the others having to negotiate
with their doctors and health insurance funds about meeting the costs.
In France, the Economic Committee on Healthcare
Products (CEPS) has set the price of Sovaldi at €13 667 before tax
for a packet of 28 pills (namely €488.10 per pill). That brings
the cost of a three-month course of treatment to €41 000 before
tax, with the reimbursement rate paid by the health insurance scheme set
The system of patents is a decisive factor in the high price
of medicines, because of the monopoly position it confers on pharmaceutical
companies, which gives them a very large amount of influence over
the setting of the prices of medicines.
argument put forward by these companies to justify the high prices
of their new medicines is the cost of R&D, a very risky business,
given that out of ten thousand or so molecules tested, only one
will reach the stage of actually being placed on the market.
However, the cost of R&D is
somewhat controversial, not only because it is never revealed in
detail and it is impossible to verify the accuracy of the figures
also because often it does not take into account public-sector funding
and also includes opportunity costs, that is what the company could
have hoped to obtain by investing elsewhere than in R&D, for
example on the stock market.
As for public-sector research, this was traditionally limited
to basic research, namely clarifying the mechanisms underpinning
diseases and identifying promising intervention points. Today it
also plays an ever growing role in “applied” research, which leads
to the discovery of medicines to treat diseases. A study published
in the United States in 2011 found that in the last 40 years, a
total of 153 new drugs, vaccines or new indications for existing
drugs had been discovered through research carried out by public-sector
research institutes. More than half of these drugs had been used
in the treatment or prevention of cancer or infectious diseases.
Similarly, in the European
Union, 44% of innovative medicines recommended for marketing authorisation
between 2010 and 2012 originated from small or medium-sized enterprises,
academia, public bodies and public-private partnerships.
towards reform of the system?
38. In the light of the considerations
briefly outlined above, more and more voices are now being heard arguing
that the patent-based innovation model is not the optimal approach
in public health matters. Admittedly it produces the highest return
on investment, but not necessarily the medicines that society needs
the most. In addition, it leads to high prices for certain new medicines,
whereas there are few higher quality medicines in clinical terms.
It is becoming increasingly more difficult for the public authorities
to cope with high prices, bearing in mind that expenditure on medicine
is set to rise considerably in the years to come, while resources are
This raises a number of questions. For example, with regard
to me-too drugs, it is quite legitimate to wonder what the point
is of paying for R&D for medicines which present no therapeutic
benefit and which do not satisfy an unmet priority health need.
What will be the consequences of me-too drugs for the sustainability of
social security systems given their potential costs? What will be
the impact of the lack of innovation in areas such as the new classes
rare diseases, paediatric diseases and those, such as Ebola, prevalent
in developing countries?
40. And what about public money invested in research? As indicated
above, a large proportion of the public budget is invested in R&D
for new medicines, without a fair return on investment. This system
is not profitable for governments and does not make for the equitable
recovery of the public funds invested. With regard to those medicines
which have a real therapeutic value but which are sold at prohibitive
prices, how will governments finance these products and ensure their
accessibility? As such, and in market economy terms, commercial
interests are hard to criticise. But I would like to ask the following
question: can there be any justification for selling to national
governments medicines at prices that are totally out of sync with
their overall costs, including research costs, and in so doing making
inordinately high profits at the expense of the national health
In order to ensure the sustainability of health-care systems
and the accessibility of affordable and innovative medicines in
the long term, I believe it will be essential to reform the current
innovation model, despite the fact that a 2009 report published
by the European Commission
the importance for the pharmaceutical sector of strong intellectual
property protection. Nonetheless, it should be pointed out that this
report confirms that there is a decline in the number of innovative
medicines coming onto the market and notes certain industry practices
aimed at delaying the entry of generic medicines into the market,
including by means of agreements/settlements with generic companies.
making proposals in this regard does not fall within the terms of
reference of the Parliamentary Assembly, but rather those of the
WHO. Still, even under the current system, it is possible to propose
measures to protect public health interests more effectively.
the best solutions to protect public health interests more effectively
42. First of all, it is essential
for there to be transparency about the real costs of R&D to
enable the public authorities to take reasoned decisions regarding
medicine prices. We must therefore demand greater transparency about
R&D costs, particularly with regard to public-sector funding
in R&D for new medicines. Furthermore, without seeking total
harmonisation, there has to be greater transparency regarding the
setting of prices in each member State, bearing in mind that there
are significant differences between them.
It would also be necessary to adopt a stricter marketing authorisation
policy at national and European level, while leaving enough margin
for second-generation medicines. Regulators could introduce a criterion such
as added therapeutic value (in relation to existing treatments)
or a “need clause”, which implies that a drug is assessed not only
from a technical and scientific viewpoint but also in relation to
medical need, making it possible to take health priorities into
possibility might also be considered of restricting reimbursement
by the social security system to only those medicines which satisfy
However, it will be necessary to ensure not only that genuinely
new medicines come onto the market, but also that effective medicines
already on the market remain there. In point of fact, the industry
may sometimes withdraw a medicine from the market, for ostensibly
While a country cannot place
an obligation on a manufacturer to produce a medicine or keep it
on the market, it could easily opt for a compulsory licence approach,
a flexibility system provided for in the Agreement on Trade-related
Aspects of Intellectual Property Rights (TRIPS). Governments can
issue compulsory licences authorising third parties to manufacture
the patented product without the consent of the patent holder. Compulsory
licences may be issued only subject to certain conditions designed
to protect the interests of the patent holder, in particular the payment
of royalties. Member States are free to specify the grounds on which
a compulsory licence may be granted, and these include the public
interest and public health.
45. Lastly, there should be a public fund to finance R&D geared
to unmet health needs. This fund could be financed by taxes, the
levies on the pharmaceutical industry proposed in paragraph 25 as
well as fines imposed on pharmaceutical companies for illegal practices
which, moreover, should be much harsher than they currently are.
In this connection, I would point out that in 2014, the Italian
Competition Authority fined the pharmaceutical groups Novartis and
Roche €182.5 million for having attempted to prevent the use of
the cancer drug Avastin to treat a serious eye disease. The Italian
regulator claimed that the two Basel-based groups had reached an
agreement to prevent the distribution of Avastin (a Roche product)
as a treatment for age-related macular degeneration in favour of
Lucentis (a Novartis product), a medicine costing up to 30 times more.
An investigation has been initiated in France by the French Competition
Authority against the two companies for similar practices. In the
same vein, agreements/settlements between the industry and generic manufacturers
to delay the entry of generics onto the market should be banned,
as such practices are directly detrimental to patients, national
health systems and taxpayers.
46. Health policies should be decided
in line with patients’ needs and public health and safety considerations.
In the medicines field, a responsible balance must be struck between
the industry’s private interests and public health interests, while
at the same time promoting a climate conducive to innovation and taking
into account future health needs. In these times of budgetary constraints,
this is all the more important in order to ensure the sustainability
of public health systems. In addition, it is essential to make sure
that decisions which have an impact on individual and public health
are free from any conflict of interest.
47. The proposals in this report seek to strike the aforementioned
balance and ensure that conflicts of interest are handled more effectively.
It is not a question of treating the pharmaceutical family as though
it were the black sheep, but to highlight systemic problems and
to come up with solutions. Clearly, the pharmaceutical industry
should foster greater awareness of its social responsibility to
respect human rights with regard to the major public health issues
and act with greater transparency. For, while it has a responsibility
to its shareholders, it also has a moral obligation to provide the
best possible assistance to patients, even if that means not going
down the most profitable route.
48. Before concluding, I would like to return to an issue very
close to my heart: clinical trials. At the beginning of my work
on this report, I took a brief look at this question, but decided
against dealing with it in detail. Not because it is less relevant,
but simply because I believe it warrants a report to itself. Clinical
trials lie at the very heart of the medicines approval process insofar
as the health authorities responsible for deciding on the effectiveness
and risks of the drug that has been tested – and granting, where
appropriate, marketing authorisation – do so on the basis of the
results of those trials, which are financed, conducted and analysed
by the pharmaceutical industry itself.
In this context, the pharmaceutical industry is criticised
for concealing and/or manipulating the results of clinical trials
so as to systematically promote the drug that has been tested, and
for failing to act transparently by refusing to publish details
of their trials. The failure to publish negative results can have
serious adverse health consequences, such as the prescribing of
an ineffective or dangerous medicine, as well as financial consequences.
the new European Regulation on clinical trials (Regulation (EU)
No. 536/2014) is likely to constitute a major step forward in terms
of transparency – as it provides that a summary of results must
be made publicly available in a European database within one year
of the end of the clinical trial in all the member states concerned
– the limitations on publication on the grounds of commercial confidentiality
and intellectual property rights could significantly weaken the
impact of the regulation. Furthermore, the EMA’s policy on access
to clinical data has been criticised for its very broad definition
of “commercial confidentiality”, which would limit access to these
data, and which therefore runs counter to the spirit of the European
Moreover, the way certain trials are conducted by pharmaceutical
companies also gives rise to strong criticism concerning, amongst
other things, failure to comply with ethical principles.
In this regard, in my
view, particular attention should be focused on the outsourcing
of trials to the developing and emerging countries – some of which
are members of the Council of Europe – insofar as there are significant
shortcomings in terms of supervision and consequently the risks
of breaches are high. I count on the members of the Parliamentary Assembly,
and in particular the members of our committee, to keep a close
watch on this issue.