Insights
A Newsletter Published by the Members of conférence bleue
June 2005 / Issue 16
MEDICINAL PRODUCT
LIABILITY IN
Paule Drouault-Gardrat,
Attorney, Bird & Bird,
The more
active a medicinal product is, the more likely it is to have side effects and
to be subject to product liability litigation. A decision from the “Cour de
cassation” (the French Supreme Court regarding civil law) dated 5 April 2005
emphasized the key points which are necessary to assess liability in this
field.
Until
recently, French case law almost systematically held manufacturers of medicinal
products liable. This was chiefly due to the fact that French judges would
admit causation between the harm sustained by the victim and the default of the
medicinal product at issue merely on the basis of presumptions. The Cour de
cassation made a first reversal by rejecting such interpretation and reminding
that the proof of causation must clearly be established by the person questioning
the safety of the medicinal product. In its decision of
In this
case, a patient who had developed a serious skin necrosis also known as the
Lyell syndrome estimated that this syndrome had stemmed from the absorption of
two medicinal products which had been prescribed to him for the treatment of a
gout attack. He consequently decided to sue the manufacturers of these two
medicinal products for injuries caused by them. After a long-running legal
battle before the first instance then appeal judges, the Cour de cassation
decided to cancel the appeal decision and to discharge one of the defendants of
its liability.
Three key points were specified as
follows by the Cour de cassation:
Firstly, the Court confirmed that the
claimant must afford sufficient evidence to prove the causal link between the
harm he sustained and the medicinal product’s default and set out several
criteria for this purpose.
Secondly, the Court made it clear
that dangerous does not mean defective. The judges of the Cour de cassation
specified that the judges of appeal should not have considered that one of the
medicinal products was defective and did not provide the safety which a person
is entitled to expect merely because “some of its active principles are
dangerous, even if the danger’s appearance is exceptional”.
The Cour de cassation specified that
it was necessary in order to assess the defectiveness of the product to take
all circumstances into account and in particular “the presentation of the
product, the use that the public could have expected from it, the time when the
product was put into circulation and the seriousness of its harmful effects”.
This position is in line with the provisions of the EC directive of 25 July 1985 and notably because it is based on the use of
the word “public” in order to assess the objective nature of the product’s
defectiveness: it is necessary to take into account the use of the medicinal
product that could have been expected collectively by the public and not only
by the patient.
Lastly, this decision highlights that
the medicinal product’s notice is of paramount importance. Before
commercializing a medicinal product, the pharmaceutical manufacturers first
have to assess the medicinal product’s dangers and possible side effects and
then to ensure that the public is well-informed of the possible risks. A
medicinal product having potentially dangerous active principles can be
considered as reasonably safe if accompanied by thorough warnings. In this
respect, the notice should be drafted very carefully. Furthermore, it is
noteworthy that a medicinal product’s approval by the AFSSAPS (French Agency for Sanitary Safety of Health Products) is not a guarantee of its
safety and will not shelter a manufacturer from liability (as results from
Article 25 of the EC directive 2001-83
of 6 November 2001 on the Community code relating to medicinal products for
human use).
This decision, which is besides in
line with the French Administrative Supreme Court (“Conseil d’Etat”) Report for
2005 advising in essence to make a reasonable use of the principle of
precaution, will definitely have a positive impact on the pharmaceutical
sector.
The
French pharmaceuticals liability regime seems to find a fair balance between
consumers’ protection and the need to encourage innovation and pharmaceutical
research.
German Government Plans to Establish a New Agency for
Medicinal Products and Medical Devices
Oliver Sude, Attorney, Ehlers,
Ehlers & Partner,
On
The
main tasks of this agency will be:
Ulla
Schmidt, Federal Minister for Health and Social Security, hopes to increase the
competitive capacity of the German authorisation body. Since EU legislation
provides for the possibility for a Member state to suspend the examination of
an application for authorisation to place a medicinal product on the market
which is currently under active consideration in another Member State with a
view to recognizing the decision reached by the latter Member State, a workable
competition among the Member States in this respect is possible. Furthermore
the EU Commission aims to reduce the number of national authorisation bodies in
order to have only a few authorities in the Member States acting as “Centres of
Excellence”. Therefore, the period for processing applications for marketing
authorizations shall be considerably shorter than it is at present with the
BfArM. At the time being every single evaluation step is processed one after
another. DAMA shall be provided with an organisation structure that enables the
authority to analyse the diverse data presented by the applicant in parallel.
In consequence innovative pharmaceuticals shall be provided sooner to the
patients.
The
bill has now been transferred to
Dispensing
of medicinal products by physicians
Dr.
Peter Bratschi, Lawyer and Ursula Eggenberger Stöckli, Lawyer and Pharmacist,
Bratschi Emch & Partner, Berne, Switzerland
The right for self-dispensation has been subject
of a lot of court decisions, because there are great financial interests behind
this right: the physicians may increase their income by a more or less easy way
and the pharmacists need to save their income.
In its most recent decision on this matter, the
Supreme Court of Switzerland has made some very clear and decisive statements,
which may show the way, this right might go in future and which will be summarized
below.
The origin for this decision is the fact, that the
Canton of Zurich has in its Law on Health (dated 1951) a provision, stating
that the self-dispensation is forbidden in the two towns
The decision of the Supreme Court is interesting
under both, formal and material aspects.
From the formal point of view, the Supreme Court
has confirmed that the pharmacists have an interest that the prohibition of
self-dispensation is respected in
From the material point of view, the Supreme Court
has stated that the regulation with the differentiation between Zurich and
Winterthur on the one hand side and the rest of the Canton on the other side
may in fact be regarded as a very global solution, but reflecting the intention
of the historic legislator who wanted to differentiate between the towns with
public pharmacies and easy access for the patients to them and the rest of the
canton. Therefore, the solution of the Cantonal Counsel in the modified
Ordinance, which allows the self-dispensation all over the
Beside this decision, which is from the legal point of view, a correct
decision, the Supreme Court makes some statements on the role of physicians and
pharmacists. Based on the education, there is a clear differentiation between
physicians and pharmacists and the self-dispensation of medicinal products is
only an additional part of the physicians work. Since they are not restricted
in their core-business by a restriction or even a prohibition of the
self-dispensation, such restrictions are allowed. It is more or less the first
time, that the Supreme Court has stated this differentiation so clear. The
consequence may be that Switzerland moves forward to a regulation and
differentiation between physicians and pharmacists that is more and more in
line with the regulation in most other countries and driven by the principle,
that physicians prescribe and pharmacists dispense medicinal products or – with
other words – that the one, who prescribes medicinal products does not dispense
them.
recent debate On and suggested changes to discounts on
pricing of medicinal products
Pauliina Tenhunen, Esq., and
Anna-Maria Palmroos, Esq., Castrén & Snellman,
The effects of generic substitution, which was launched
in 2003, have once again been subject to severe debate and legislative draft
proposals in
Pursuant to Finnish legislation, the Pharmaceuticals’
Pricing Board approves the reasonable wholesale price for the medicinal
products to serve as the basis for reimbursement when the marketing
authorization holder opts its products to be subject to the reimbursement. The
retail price of a pharmaceutical product, including the pharmacy’s profit
marginal, is also clearly regulated. This retail price is not affected by any
discounts given to the pharmacies. Furthermore, the pharmacies are not entitled
to grant discounts on the medicinal products, except for in the course of
certain customer related schemes and for the veterans of war.
Now the question has been raised over the legality and
purpose of the discounts granted by the pharmaceutical companies to pharmacies,
as these discounts do not reduce the retail prices.
In order to evaluate the current scope of discounts
granted in Finland the National Agency for Medicines circulated a request for
information for all Finnish pharmacies and marketing authorization holders as
ordered by the Ministry of Social Affairs and Health. In their responses, the
pharmacies and pharmaceutical companies were to disclose the status of their
recent discount practices and other arrangements favoring any of the products
subject to generic substitution in
From the requests of information circulated it may be
seen that the Ministry initially considered these discounts could be contrary
to the Medicines Act (395/1987 as amended) and especially its provisions on
generic substitution and permissible inducements given to pharmacists and other
pharmacy personnel.
To our opinion, no express provisions prohibiting such
discounts are included in the Finnish legislation and the provisions on
permissible inducements do not mention or concern given discounts. This view is
supported both by the legislative underlay of the Medicines Act and the EU
directive 2001/83/EC which, in Article 94, clearly states that the already
existing trade practices relating to discounts shall remain unaffected by the
provisions on the acceptable level of gifts or other inducements to be given to
the pharmacy.
It remains to be seen whether the competent authorities
deem any subsequent measures regarding the discounts already given or pending
necessary or legitimate. As indicated above, we do not consider any changes to
the existing structure possible without legislative efforts.
Based on the wide debate and the inquiries made, it is
not surprising that the Ministry of Social Affairs and Health introduced the
first draft for legislative measures already on April 29, 2005. The Ministry is
circulating this draft proposal to obtain comments from all
relevant actors in the field. To summarize, it is proposed that the wholesale
price be equal for all pharmacies and that all discounts given be also taken
into account when determining this price. Based on the draft proposal, this
would mean that no individual discounts would be allowed.
Disclaimer:
This
Newsletter is intended to provide general information on the members of
conférence bleue and on recent developments of relevance to the pharmaceutical
sector. The information and opinions which it contains are not intended to
provide legal advice, and should not be treated as a substitute for specific
advice concerning particular situations.
Editor
conférence bleue members
Austria: Schönherr Rechtsanwälte, Tuchlauben 17, P.O. Box 41, A-1014
Vienna, www.schoenherr.at
Belgium: White & Case LL.P. incorporating Forrester
& Sutton, 62, rue de la Loi, B-1040 Brussels, www.whitecase.com
Cyprus:
Antis Triantafyllides & Sons, Capital Center, 9th Floor, Nicosia
1505, www.triantafyllides.com
Denmark: Jonas Bruun, Bredgade 38, DK-1260 Copenhagen K, www.jonasbruun.dk
Finland: Castrén & Snellman, Attorneys at Law,
Erottajankatu 5A, FIN-00130 Helsinki, www.castren.fi
France: Bird & Bird, Centre d'Affaires Edouard
VII, 6 Rue de Caumartin, Paris 75009, www.twobirds.com
Germany: Ehlers, Ehlers & Partner, Rechtsanwaltssocietät,
Widenmayerstrasse 29, D-80538 Munich, www.eep-law.de
Greece: M. & P. Bernitsas Law Offices, 5,
Lykavittou Street, GR-106 72 Athens, www.bernitsaslawoffices.gr
Hungary: S.B.G.&K. PATENT AND LAW OFFICES, Andrássy
ÚT 113, H-1062 Budapest, Mailing address: P.O. Box 360, H-1369, www.sbgk.hu
Ireland: Matheson Ormsby Prentice, 30 Herbert Street,
Dublin 2, www.mop.ie
Italy: Avvocati Associati Franzosi Dal Negro Pensato
Setti, Via Brera 5, I-20121 Milan, www.franzosi.com
Netherlands: Brinkhof, De Lairessestraat 111-115, 1075 HH
Amsterdam, www.brinkhof.com
Norway: Advokatfirmaet Haavind Vislie DA, Raadhusgaten
27, P.O. Box 359, N-0101 Oslo, www.haavind.no
Spain: Jausàs, Advocats, Avda. Diagonal, 407 bis, E-08008 Barcelona, www.jnv.com
Sweden: RydinCarlsten, Advokatbyra AB, Norrmalmstorg 14, P.O. Box
1766, SE-11187 Stockholm, www.rydincarlsten.se
Switzerland: Bratschi Emch & Partner, Advokaturbureau, Bollwerk 15,
P.O. Box 5576, CH-3001 Bern and Bahnhofstrasse 106, 8023 Zürich, www.bep.ch
United Kingdom: Arnold & Porter, Tower 42, 25 Old Broad
Street, London EC2N 1 HQ, www.arnoldporter.com
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