|
|
|
January-February
2009
Estonia, Latvia, Lithuania, Finland, Sweden |
|
RoschierRaidla News
|
| |
| |
|
Inside this Issue:
|
| |
|
Estonia |
| |
|
|
| |
|
Latvia |
| |
|
|
| |
|
Lithuania |
| |
|
|
|
|
|
| |
|
Estonia
|
|
|
|
Recent Tax Updates |
|
|
|
On 19 November 2008, the Estonian Parliament (Riigikogu)
passed the Act Amending the Income Tax Act, Value Added Tax Act and
State Fees Act. As a result of the amendment the timeframe for
reducing the income tax rate is changed and the next reduction is
postponed by a year. Thus the income tax rate for 2009 remains at
21%. In 2010 the income tax rate drops to 20%, in 2011 to 19% and
stays at 18% from 2012. By the same token the increase in the basic
exemption is postponed by one year: in 2009 the basic exemption
remains on the level of that of 2008 (27 000 EEK per year); rising
to 30 000 EEK in 2010, 33 000 EEK in 2011 and from 2012 onwards the
basic exemption will be 36 000 EEK per year. Resulting from the
changes in the Value Added Tax Act, the VAT rate increases from the
current 5% to 9% for books, medicinal products, periodicals and
accommodation services; while the handling of hazardous waste,
funeral items and services, as well as tickets for performances and
concerts shall be subject to the full 18% rate. The amendments
entered into force on 1 January 2009.
On 20 November 2008, the Riigikogu passed the Income Tax Act
Amendment Act. In March 2008 the Riigikogu had adopted
amendments to the Income Tax Act, pursuant to which companies were
to start paying taxes on an annual basis and in some instances also
start making advance payments of income tax in the course of the
year etc. Those amendments were to become applicable as of 1 January
2009. Given the changing economic environment the parliament
decided, in an amendment passed on 20 November 2008, that only some
of the scheduled changes would be introduced on 1 January 2009.
Those amendments concern taxation of amounts received through
capital reductions and payments in connection with winding up of
companies. The plans of transition to advance payment of tax and
taxation on an annual basis were dropped. The amendments entered
into force on 1 January 2009.
On 4 December 2008, the Riigikogu passed a further Act
Amending the Value Added Tax Act and Income Tax Act. As a result,
more than 60 amendments can be found in the Value Added Tax Act.
Thorough changes are introduced to the rules governing the
registration of taxable persons as a single taxable person and
transactions between persons registered as a group of taxable
persons. A fundamental change follows from this: a person registered
as a group of taxable persons is deemed as one person for the
purposes of its dealings with third parties. Before this amendment
persons registered as a single taxable person conducted transactions
with third parties each in their own name. A taxable person may not
belong to more than one group of taxable persons at the same time.
Further amendments include provisions for establishing the taxable
value of transactions between related parties, exemptions and
invoices. It is now possible to register as a person liable to value
added tax through the information system of the commercial register
by using a digital signature or through the E-notary information
system, on the basis of an application executed by a notary. The
following amendment was made in the Income Tax Act: the maximum
price of a fringe benefit for the use of an automobile of the
employer free of charge or at a preferential price for activities
not related to the employer's business is 4000 EEK per month. The
previous maximum price was 2000 EEK per month. The amendments
entered into force on 1 January 2009, except those scheduled to
enter into force at another time prescribed by the amended act.
On 4 December 2008, the Riigikogu passed the Taxation Act and
Associated Acts Amendment Act. The amendments introduce sweeping
changes in the system of payment and set-off of taxes and in the
provisions regulating claims for refunds. As a result of the
changes, taxable persons may meet all of their obligations by making
payments to just one bank account of the tax authority. In order to
ensure timely payment of any future financial obligations, taxable
persons have the right to remit amounts to the bank account of the
tax authority prior to the due date for settling a financial
obligation. On the due date the tax authority sets off the financial
obligations of the taxable person against its claims for refunds, in
the order in which the financial obligations are paid or set off.
The amendments entered into force on 1 January 2009.
top
|
| |
|
Other Recent Legislative Developments |
|
|
|
Equal Treatment Act
On 11 December 2008, the Riigikogu adopted the Equal Treatment
Act. The objective of the act is to protect persons against
discrimination. To achieve this objective the act defines the
principles of equal treatment and societal obligations to implement
them. The act also establishes the legal bases and competence of the
activities of the gender equality and equal treatment commissioner,
as well as the procedure for resolving disputes concerning
discrimination. The act entered into force on 1 January 2009.
Machinery Safety Act
On 10 December 2008, the Riigikogu passed the Machinery Safety
Act. There are no fundamental changes in comparison with the current
act. The main reasons for adopting the new act derive from the need
to regulate certain matters as required by EU directives. Those
include the introduction of new terms, requirements concerning the
placing on the market of machinery and the requirements for notified
bodies and persons in charge of machine work, as well as provisions
regulating the certification of staff. The act entered into force on
29 December 2008.
Reorganization Act
On 4 December 2008, the Riigikogu adopted the Reorganization
Act. The act provides the regulation for conducting reorganization
proceedings, which is new in the Estonian legal environment. The
proceedings should serve as an alternative for bankruptcy
proceedings and help reduce the number of enterprise liquidations.
The purpose of reorganization is defined as the application of a set
of measures in order for an enterprise to overcome economic
difficulties, to restore its liquidity, improve its profitability
and ensure its sustainable management. According to the act
reorganization proceedings are proceedings on petition in which the
reorganization petition is submitted by the undertaking. If
sustainable management of the enterprise is likely after the
reorganization the court commences reorganization proceedings,
designates a reorganization adviser and later approves the
reorganization plan, whereas the reorganization adviser exercises
supervision over compliance with the reorganization plan. The
reorganization plan sets out the measures for overcoming payment
difficulties and the term during which the claims of obligees are to
be satisfied. The Reorganization Act entered into force on 26
December 2008.
Commercial Code Amended
On 19 December 2008, the Riigikogu passed the Act Amending the
Commercial Code, the Penal Code and Associated Acts. The aim of the
amendments is to change the rules for electing directing bodies of
legal persons so as to prevent third parties from appointing,
unbeknownst to the shareholders or management board of a private
limited company, unknown persons as members of the management or
supervisory board of the company, by using forged documents. To this
end, stricter rules were prescribed in the Commercial Code for the
procedure of adopting and executing a shareholders' resolution
concerning the election of management board members. The changes
also pertain to registration of prohibitions to engage in business
imposed pursuant to the rules of the Bankruptcy Act and the Penal
Act. The amendments entered into force on 22 December 2008.
Use of Digital Stamps Introduced by Law
On 4 December 2008, the Riigikogu adopted the Act Amending the
Digital Signatures Act and the Administrative Procedure Act. The
amendment creates a legal basis for the use of digital stamps. A
digital stamp is defined as a data unit which is created using a
system of technical and organizational means which the holder of a
digital stamp certificate uses to certify the integrity of a digital
document and to indicate the holder's connection to the document. In
addition to natural persons legal persons may also be holders of
such certificates. The act entered into force on 12 January 2009.
Excise Duty Acts Amended
On 6 November 2008, the Riigikogu adopted the Act Amending the
Alcohol, Tobacco, Fuel and Electricity Excise Duty Act and
Associated Acts. More than one hundred changes are made in the
Alcohol, Tobacco, Fuel and Electricity Excise Duty Act. Oil shale
used for the generation of heat is now included among fuels and
shall be subject to excise duty from 2011. Other provisions
specified include the conditions for producing excise goods,
collection of the duty and exemptions from excise duty. Additional
requirements are introduced for measuring excise goods and for
registered traders. Further amendments pertain to the provisions
regulating excise warehouse activity licenses and activity licenses
of registered traders, as well as refunds of excise duties and
duty-free limits for excise goods imported by travelers. The
amendments entered into force on 1 January 2009, except those
scheduled to enter into force at another time prescribed by the
amended act.
top
|
| |
|
|
| For further information please contact
Raino Paron
(CV),
Partner at Raidla Lejins &
Norcous in Tallinn. |
| |
|
Latvia
|
|
|
|
Voting Requirements for Joint Stock Companies
Relaxed |
| |
|
On 18 December 2008, the Latvian
Parliament (Saeima) passed
amendments to the Commercial Law
relaxing certain provisions of the
Commercial Law that restricted
freedom of shareholders of joint
stock companies to specify in the
company’s constitutive documents the
number of votes needing to be cast
in favor of a decision of general
meeting of shareholders. The
amendments entered in force on 21
January 2009 and thus predated by
several days the ruling of
Satversmes Tiesa (the
Constitutional Court of Latvia) on
the same subject matter rendered on
4 February 2009 and holding these
restrictions unconstitutional.
Prior to the amendments the law
required that decisions of
shareholders’ meetings of joint
stock companies are taken by a vote
of a simple majority of shareholders
present at the meeting, while
certain fundamental decisions like
amendments to the charter (articles
of association) of the company,
increase or decrease of the equity
capital, issuance of convertible
bonds, company’s reorganization and
liquidation requited a vote of three
quarters of the shareholders
present. The companies were not
allowed to vary these voting
majorities in their constitutive
documents. By the amendments to the
Commercial Law of 18 December 2008
the above joint stock company
shareholders’ meeting decision
taking majorities were made as the
statutory minimum of votes required
to be cast in favor of a decision to
be taken and the joint stock
companies are now free to determine
in their constitutive documents the
decision taking majorities that are
higher than these minimums.
Notwithstanding that the amendments
to the Commercial Law had cured the
contested issue, on 4 February 2009
Satversmes Tiesa took a
decision not to stay its proceedings
on a complaint of a private person –
a shareholder in a joint stock
company, alleging
unconstitutionality of the provision
of the Commercial Law under which
the joint stock company was not
permitted to provide in its
constitutive documents the
shareholders’ meeting decision
taking majority that was higher than
the one required by the law, and
rendered a full ruling on the
contested issue. Satversmes Tiesa
recognized the provision as being in
breach of persons’ constitutional
right to property. In addition, it
declared the provision as void ab
initio in respect of the joint
stock company whose shareholder the
complainant was. This is the first
ruling of the Latvian Constitutional
Court on the matters of Latvian
corporate (company) law.
top |
| |
|
New Regulation of Commercial Transactions |
| |
|
On 18 December 2008, the Saeima supplemented the Commercial Law with a
new section on commercial (business) transactions. This section will enter in
force on 1 January 2010 and will provide specific regulation for the business
transactions in which at least one of the parties to the transaction is a
business person or business entity and where the particular transaction is
entered into in that person’s or entity’s course of business. Thus, the new
regulations will apply to virtually all legal entities and individuals whose
business is sale of goods or provision of services.
The new regulation of business transactions will preempt application of any
inconsistent provisions of the Latvian contract law. The new regulations will
also apply to business transactions with consumers except to the extent
specified otherwise in the consumer protection law.
The new regulation of commercial transactions will, inter alia, for the first
time in Latvia regulate such transactions as franchise agreements, factoring and
leasing transactions none of which are currently specifically referred to or
regulated by the Latvian contract law. In addition to these, specific provisions
will be introduced in respect of commercial sale, commercial agency, expedition
(transportation) and commercial storage transactions.
top |
| |
|
Bank Take-Over Law and its Implementing
Regulations Passed |
| |
|
On 18 December 2008, the Saeima
passed a Bank Take-over Law
specifying the grounds and
procedures under which Latvia state
through its entities or state-owned
companies may voluntarily or
involuntarily take-over the banks
registered in Latvia, as well as
their foreign branches, by forcing
out some or all of the existing bank
shareholders or taking over the
assets or rights of the bank. The
Law entered in force on 31 December
2008. The Law does not apply to the
Latvian branches of the banks
registered in other EU member states
or in third countries.
According to the Bank Take-over Law,
a bank may be taken over in a
situation when stability of the
Latvian banking system and smooth
operation of its payment system is
under a material threat or would be
under such threat if the bank was
not taken over and the bank
therefore is not able or would not
be able to meet the banking
regulatory requirements. The
take-over may be made either as a
voluntary take-over on a basis of a
contract or as a forced
(involuntary) take-over pursuant to
a specific law.
The bank take over process may be
commenced either by the Finance and
Capital Markets Commission (the
Latvian banking supervisor) or the
Bank of Latvia (the Latvian central
bank) by making a motivated proposal
to the Ministry of Finance. In case
all of the Finance and Capital
Markets Commission, the Bank and
Latvia and the Ministry of Finance
agree that there is a reason to take
over the bank, the Ministry of
Finance commences negotiations with
the bank or its shareholders on the
takeover. In case the agreement is
reached within not more than 5 days,
the matter is submitted to the
Cabinet of Ministers (the
Government) for its approval. In
case the agreement is not reached
within 5 days, the Ministry of
Finance will propose a draft law on
the take-over of the bank to the
Cabinet of Ministers to be made as a
legislative initiative to the
Parliament.
The Bank take-over may be effected
as a take-over of shares, assets,
rights or obligations. If shares are
taken-over in a forced (involuntary)
take-over, the pledges and other
encumbrances attached to the shares
are discharged under the relevant
take-over law unless the taking-over
state entity has agreed to take them
over. The secured creditors whose
security interests are thus wiped
out will have a priority right to
the compensation paid for the
shares, if any. There are no
comparable provisions in respect of
take-overs of assets or rights
subject to pledge.
The law requires that in case of a
forced (involuntary) take-over of
the bank a fair compensation is paid
to the shareholders, if shares are
taken-over, or to the bank, if
assets or rights are taken over, in
the amount determined by the Cabinet
of Ministers based on the bank’s
value on the date when the take-over
process was commenced. The Cabinet
of Ministers has passed a specific
Cabinet of Minister’s regulation on
the determination of the
compensation. According to this
regulation, the amount of
compensation payable to the
shareholders or the bank is equal to
the positive difference between the
aggregate balance sheet value of the
bank’s assets and the liquidation
(fast sale) value of the bank’s
assets. In essence, it means that no
compensation is payable if the
valuation committee appointed by the
Finance minister would determine
that the liquidation value of the
bank’s assets is larger than their
balance sheet value.
top |
| |
|
|
| For further information please contact
Dace Silava-Tomsone
(CV),
Partner at Raidla Lejins
& Norcous in Riga. |
| |
|
Lithuania
|
|
|
|
Recent Tax Updates |
|
|
|
During December 2008, the Parliament of
the Republic of Lithuania (Seimas)
passed several laws Amending the Law on
Corporate Income Tax. The amendments
increased the income tax rate for 2009
from 15% to 20% for the income of
Lithuanian entities and permanent
establishments of foreign entities,
which are subject to taxes; for
dividends and other distributed
earnings, as well as for the financial
support received, which exceeds 250
minimum standards of living and for
earning of foreign entities, which were
not received in their permanent
establishments in Lithuania. The
amendments also provided that income
from increase in asset value for shares
transfer is not subject to taxes, if
shares were transferred to an entity
under reorganization or other cases
defined in the Law, and if such entity
possessed 25 per cent of unit’s voting
power for an unbreakable period of three
years or more, the shares of which are
being transferred. The amendments also
abolished tax exemptions for corporate
income tax of entities engaged in
agricultural activities, credit unions
and Central Credit Union. The amendments
entered into force on 30 December 2008.
Seimas also passed several laws
amending the Law on Value Added Tax. As
a result of the amendments, standard
value added tax was increased from 18%
to 19%. The reduced value added tax rate
shall be applied to heating energy,
supplied to residential premises and to
hot water, supplied to residential
premises. The reduced value added tax of
5% will also be applied to medicines and
medical products to full or partial
compensation from the state medical
insurance budget. It is also important,
that the new reduced value added tax
rate of 9% was established in respect of
books and non-periodical publications,
as well as periodical publications,
provided that the subscription fees for
the periodical publications for the 2009
were fully paid till 31 December 2008.
What is more, the reduced value added
tax rate of 5% may be applied to
accommodation at hotels and other
special accommodation services during
2009 if the booking was completed prior
to 31 December 2008. The reduced value
added taxes of 5% will be applicable
only until the terms established at the
law. The amendments entered into force
on 1 January 2009, except those
scheduled to enter into force at another
time prescribed by the amended law.
top |
| |
|
Other Recent Legislative Developments |
|
|
|
The Civil Procedure Code
Amended
On 14 November 2008, the
Seimas adopted the Law
Amending the Civil Procedure
Code. The amendments firstly
concern the provisions
regulating the activities of
bailiffs. They establish
that the claim concerning
the activities of a bailiff
or notary public may be
submitted not later than
within twenty days from the
day the person became aware
of or was supposed to become
aware of the performance of
the disputed activity or the
refusal to perform it, but
not later than within ninety
days from the performance of
the disputed activity.
Moreover, other amendments
specify in detail the
provisions, regulating the
procedure of the execution
of judgements. It also needs
mentioning that the law will
enter into force on 1 April
2009.
The Civil Code Amended
On 16 December 2008, the
Seimas passed the Law
Amending the Civil Code.
Considering the legal notice
on violations from the
Commission of the European
Communities this Law seeks
to impose into Lithuanian
law the provisions of the
European Council Directive
on Unfair Terms in Consumer
Contracts. The aim of the
amendments is to create the
better protection of the
consumers’ rights, by
establishing that any
written condition of the
consumer contract must be
put clearly and
understandably. In case
there are any doubts about
conditions of consumer
contact, they must be
interpreted in favour of the
consumer, excluding those
cases, when it is sought to
forbid further usage of the
prepared standard conditions
of the contract. These
amendments entered into
force on 30 December 2008.
The Law on Lottery and
Gaming Amended
On 19 December 2008, the
Seimas passed the Law
amending the Law on Lottery
and Gaming Tax. The
amendments establish the
increased fixed taxes on
lotteries and gaming. As a
result of the changes, every
legal entity, operating
gaming machines and table
games, shall pay a larger
fixed fee for every gaming
machine indicated in the
gaming license. However, the
rates of tax applied for
operators of lottery, bingo
and betting have not been
amended. The amendments
entered into force on 1
January 2009.
The Law on Excise Duty
Amended
On 19 December 2008, the
Seimas adopted the Law
Amending the Law on Excise
Duty. The aim of the law was
bound to ensure additional
income for the budget of the
state. Increasing excises
was one of the measures that
should have been taken in
order to defeat the
financial crisis, according
to the Financial Crisis
Prevail Plan approved by the
Government of the Republic
of Lithuania. The law
increased excises for the
ethyl alcohol, manufactured
tobacco products and energy
products, including fuel.
Other provisions abolished
excise duty relief for small
beer breweries. The
amendments entered into
force on 1 January 2009,
except those scheduled to
enter into force at another
time prescribed by the
amended law.
Labor Code Amended
On 19 December 2008, the
Seimas passed law
amending the Law on Labor
Code. As a result of the
amendments, the provisions
of the Code, stating that
the rest days, which
coincide with public
holidays, shall be
transferred to the nearest
succeeding work day or that
collective agreements may
settle different procedures
of transferring the rest
days, which coincide with
public holidays, are
repealed.
The
amendments entered into
force on 1 January 2009.
Law on the Establishment of
the Ministry of Energetic
Passed
On 12 January 2009, the
Seimas passed the Law on
the Establishment of the
Ministry of Energetic. The
aim of the law was to
establish the Ministry of
Energetic in order to ensure
the effective control of the
energetic sector of the
Republic of Lithuania. For
that reason, a part of the
functions related with the
energetic sector and which
previously have been
executed by the Ministry of
Economy, were delivered to
the newly established
Ministry of Energetic. The
Ministry will aim to secure
the implementation of the
future goals for the
Lithuanian energetic,
ensuring the further
integration of Lithuanian
energetic to the European
Union energetic systems and
the effective control of
Lithuanian energetic
infrastructure development.
The enactment of this law
determined the obligation of
the Republic of Lithuania to
amend a variety of legal
acts, concerning the
energetic activities. The
law entered into force on 13
January 2009.
top |
|
|
|
|
|
| For
further information please contact
Irmantas Norkus, (CV),
Managing Partner at Raidla Lejins & Norcous in Vilnius. |
| |
|
Finland
|
|
|
|
Working
Group Report on the Revision of
the Finnish Competition Act |
| |
|
The working group appointed
by the Ministry of Trade and
Industry (presently the
Ministry of Employment and
the Economy) submitted its
report on the revision of
the Finnish Competition Act
(“Competition Act”) to the
Minister responsible for
competition matters, Ms
Tarja Cronberg. The working
group proposes that the
current Competition Act be
repealed and replaced by a
new Competition Act, as the
current Competition Act is
no longer fully logical and
clear due to several partial
revisions.
The working group proposes substantive changes to the Competition Act in respect
of merger control, procedural rules, sanctions and compensation for damage. In
addition, the working group proposes that provisions on a business undertaking’s
rights of defense are included in the Competition Act. The latter amendment
would be mainly for informational purposes, as the rights of defense already
have to be taken into account on the basis of administrative provisions and
principles.
The main amendment proposed by the working group in respect of merger control is
to replace the dominance test applied under the current Competition Act with the
so called SIEC-test (significant impediment of effective competition), which is
applied by the Commission. The working group also proposes, inter alia, that the
deadline for notifying a concentration to the Finnish Competition Authority (“FCA”)
should be abolished from the new Competition Act.
In respect of procedural rules, the working group aims to expedite the FCA’s
investigations and to enable the FCA to focus on investigating the most serious
restrictions of competition by giving it greater possibilities to dismiss an
action if it is obvious that an investigation is not necessary taking into
account the objective of the Competition Act and the functioning of the market
as a whole. The working group also proposes amendments to the Act on the
Openness of Government Activities in order to protect the integrity of the FCA’s
investigations and to maintain the confidentiality of information submitted to
the FCA in a leniency application. Furthermore, the working group proposes that
the FCA be given the right to carry out inspections at private premises with the
permission of the Finnish Market Court, a right which the Commission and other
Nordic competition authorities already have.
As regards the sanction system, the working group proposes amendments to enhance
the effectiveness of sanctions and to render the system more predictable. The
proposed provision is closely aligned with the principles adopted in the
Commission’s Guidelines in the method of setting fines, according to which,
e.g., the duration of the infringement has a direct effect on the amount of the
fine. In addition, the working group proposes that the leniency system be
aligned with the Commission’s Leniency Notice and the Model Leniency Program of
the European Competition Network in order to make it more predictable and to
increase incentives for companies to blow the whistle on cartels they
participate in. In regard to compensation for damage, the working group proposes
that the scope of application of the provision on compensation for damage be
amended to cover also consumers.
The working group report is only the first step in the revision process the next
step being the submission of the Government Bill. The new Competition Act is
expected to enter into force in 2010.
top |
| |
|
|
|
For further information please contact
Christian Wik
(CV),
Partner at Roschier in Helsinki. |
|
|
|
|
Sweden
|
|
|
|
The European
Commission
Pharmaceutical
Sector Inquiry –
Preliminary Report |
| |
|
The observations
from the
stakeholders
have now been
submitted in
reply to the
Preliminary
report by the
European
Commission on
its inquiry in
to the
pharmaceutical
sector. The
report was
issued last
year, on 28
November 2008
and a final
report is
expected in late
spring or early
summer 2009.
The sector
inquiry began
with dawn raids
at the premises
of a number of
pharmaceutical
companies in
Europe. The
Commission
supplemented
this
fact-finding
with numerous
and sometimes
extremely
detailed
questionnaires
to stakeholders,
i.e.
pharmaceutical
companies,
competition
authorities,
consumer
associations,
patent offices,
patient
associations and
insurance
companies. The
result is a
preliminary
report of 426
pages.
What are the
major findings
stated in the
preliminary
report?
First, the
Commission
claims that the
originator
companies are
using a variety
of strategies,
what the
Commission calls
a “toolbox” to
delay or prevent
the entry of
generics in
order to ensure
continued
revenue streams
for their
medicines. These
include multiple
patent
applications
around the same
medicine (so
called patent
clusters),
initiation of
disputes and
litigation,
conclusion of
patent
settlements
which constrain
market entry of
generic
companies and
interventions
before national
authorities when
generic
companies ask
for regulatory
approvals or in
the pricing and
reimbursement
process.
There is
currently a
large debate
underway on both
sides of the
Atlantic whether
or not and under
what conditions
multiple patent
applications can
violate
competition law.
The Commission’s
view seems to be
that the two
areas of law do
not stand
separate from
each other,
leaving itself
open the option
to prosecute any
use of the
patent system
that it regard
as abusive.
Second, the
Commission found
that the
originator
companies have
developed
“defensive
patenting
strategies” in
order to block
the development
of new products
by other
companies.
Another issue
that has proven
problematic
relates to the
numerous
overlaps between
patents held by
different
pharmaceutical
companies. The
inquiry revealed
that at least in
1,100 cases
across the EU
the patents held
by an originator
company might
overlap with the
R&D program
and/or patents
held by another
originator
company for
their medicine.
Finally, the
preliminary
findings
revealed a high
number of
contractual
agreements
between
originator
companies, the
majority
concerning the
commercialization
phase.
One issue, which
was commented on
already at the
public
presentation of
the preliminary
report on 28
November 2008 is
that the report
does not examine
competition
among generic
companies as
such even though
the preliminary
report mentions
misuse of the
regulatory
system by “some
(generic)
applicants, who
use various ways
of making
“unnecessary”
bookings in
order to delay
access for other
applicants. Nor
does it deal
with parallel
trade issues
within the EU.
However, one of
the dawn raids
in the second
wave was aimed
at a generic
company.
What practical
impact will the
preliminary
findings have on
the
pharmaceutical
industry as a
whole?
The report
contains a
number of
allegations that
appear to
challenge
practices that
are fairly
common within
the industry.
While the report
is not
definitive or
even conclusive,
it is rather
unlikely that
the Commission
will be
convinced that
its findings are
wrong. In fact,
Commission
officials have
already
conducted dawn
raids in several
Member States at
the premises of
a few
pharmaceutical
companies. In
the press the
Commission
stated that the
inspections were
not related to
the sector
inquiry.
However, the
Commission did
admit that the
knowledge
acquired during
its sector
inquiry allows
it to draw
conclusions on
where to conduct
“action based on
competition
law”. It would
therefore appear
more than likely
that the sector
inquiry will
ultimately lead
to further dawn
raids and
proceedings
initiated by
both the
Commission and
perhaps also by
national
competition
authorities.
Commissioner
Neelie Kroes has
also made
statements that
the Commission
will not
hesitate to open
anti-trust
cases.
A new chance for
the EU patent
system?
In view of the
efforts and
resources put
down in this
sector inquiry,
it seems likely
that the
pharmaceutical
sector will
continue to be
at the center of
the Commissions
attention and
that it will
take active
steps also in
other areas,
i.e. not limited
to competition
law, in order to
enhance
competition in
the market. It
should not come
as a surprise if
the Commission
will use this
report to build
support for the
harmonization of
the EU patent
system. It is
likely that
further
legislative
proposals to
bring about such
harmonization
will be put
forward on this
in due course.
Initiatives for
harmonization of
the EU patent
system have been
sought by the
Commission for
years, but have
failed, mainly
on disagreements
regarding
languages and
jurisdiction. It
remains to be
seen whether
this time will
be any
different.
Could there be
other causes of
generic delay?
In respect of
the regulatory
issues, the
Commission noted
that there
appear to be
bottlenecks in
the approval and
marketing of
medicines, which
delay products
coming to the
market. For
example, some
agencies lack
adequate
resources and
there are
discrepancies in
assessment
criteria on
marketing
permissions and
national pricing
and
reimbursement
procedures which
create delay and
uncertainty.
Some
commentators
have even gone
as far as to ask
whether the
delays for
generic products
are not caused
by
administrative
problems rather
than the
toolbox. It
remains to be
seen whether
these concerns
will be
addressed by the
Commission in
the final
report.
Is the report of
any relevance
for other
industries?
The
distinctive
features of the
pharmaceutical
sector may lead
people to the
conclusion that
the Commission’s
view (and
criticism) will
only affect
companies active
in that sector.
This approach
can be
dangerous. There
are several
industries where
the competition
for different
reasons is less
well
functioning,
which from this
perspective can
be compared with
the
pharmaceutical
sector. Typical
examples of such
sectors are
newly
de-regulated
sectors and
markets with
strong
regulatory
elements.
Also, as IPLA
and other
commentators
have concluded,
many of the
practices
attacked by the
Commission are
inherent in the
patent system.
For example, the
filing of
divisional
applications is
a necessary part
of the patent
prosecution
procedure, and
companies in all
sectors use the
procedure in
essentially the
same way.
For Sweden, the
pharmaceutical
industry stands
for 0.5% of the
GNP and employs
thousands of
people in
Sweden. The
export net is
for example
three times
higher than the
car industry.
Any negative
effects on the
pharmaceutical
sector are
therefore likely
to also effect
Sweden.
top |
|
|
|
|
| For further information please contact
Axel Calissendorff
(CV),
Partner at Roschier
in Stockholm. |
| |
|
|
|
| This Newsletter is a
periodic publication of RoschierRaidla and
should not be construed as legal advice or legal opinion on any specific
facts or circumstances. We have used reasonable efforts in collecting,
preparing and providing the information in this newsletter, but we do
not warrant or guarantee the accuracy, completeness, adequacy or
currency of the information contained herein. The contents are for
general informational purposes only, and you are urged to consult a
lawyer concerning your situation and any specific legal questions you
might have. |
| |
|
|
|