Regulatory Affairs
Journal, 2002, V
ol. 13(8), 653-660
The Position of Co-marketing and Co-
promotion Between EU Regulatory and Competition Rules
_____________________________________________________________________
Carlo
Piria explains
the regulatory aspects and limitations of co- marketing and co- promotion.
Carlo
Piria is
a partner in Avvocati Associati Franzosi, Milano, Italy.
The purpose of this paper
is to analyse the structure of co- marketing and co- promotion agreements in the
pharmaceutical industry in the light of the regulatory provisions and
competition law in force in the European Community (EC). The pharmaceutical
legislation of the EC has consistently pursued two objectives: the
protection of public health and the free movement of medicinal products.
Therefore, the regulatory provisions cannot be read alone, but must always be
interpreted in close connection with the general rules of the Treaty
establishing the European Community and EC legislation which is intended to
safeguard the free circulation of goods and competition among business
organisations1.
Defining co-
marketing and co- promotion
Co- marketing and co-
promotion are standard agreements and practice in the pharmaceutical industry.
Co- marketing consists of the sale and marketing of a defined product, which is
to be conducted independently and under different trademarks by each party in a
defined territory in accordance with the terms and conditions of the agreement.
Co- promotion consists of the sale and marketing of a defined product under a
single trademark, where the parties co- operate in managing the overall process
of commercialisation, from the manufacture through to sale to the ultimate
consumer. In
those countries where the promotion of a product under a single trademark by
more than one company is permitted, co- promotion and co- marketing are
sometimes interchangeable terms; in those countries where such a form of
commercialisation is not allowed, co- marketing is generally referred to in
opposition to co- promotion, and co- promotion describes the non- permissible
activity.
Co- promotion does not
require further description and comment, as it is sufficiently defined by the
concentration of the promotional efforts of co- promoters on a single brand.
In co- marketing, the contemporary presence of at
least two trademarks requires some differentiation from thostion agreements
undoubtedly pose problems with respect to the competition rules in the EU. Co-
marketing and co- promotion by their very names express more than the simple
fact of there being more than one player in the market place with the same
product. They imply a co- ordination of policies that may include co- ordination
of price policies to offer the same product, irrespective of the difference of
trademare situations where more than one company are engaged in the
commercialisation of identical products, distinguished by different tradenames,
but there is no co- marketing agreement. The essence of co- marketing provides
that all of the following conditions are met:
·
There are at least two marketing
authorisations identical in all respects but the tradenames, and all having a
common origin as far as the registration dossier is concerned. (Where a dossier
of common origin is lacking, even if there is identical product composition and
the product constituents have a common origin in terms of manufacturing sources,
the activity is not considered to be co- marketing. However where there is a
common dossier, it is irrelevant whether or not there are supply relationships
or other commercial agreements between co- marketers, even if these consist of
licences under patents or know- how; the common registration dossier is of the
essence).
·
There is ownership by the
originator of the dossier (or one of its affiliates) of the marketing rights
(promotion and sale) in the contractual territory.
·
There is contemporary
enjoyment of similar marketing rights in the same territory by an unaffiliated
company under a temporary agreement, such as that which may be obtained by means
of consent to access the registration dossier or the assignment of a marketing
authorisation or any other form of transfer of, or entitlement to, the
regulatory situation which permits the promotion and sale of the product in the
contractual territory.
Co- marketing may be put
in place between subjects none of whom is a marketing authorisation holder (for
instance, two companies, one being the national affiliate of a group to
which the company holder of all the centralised marketing authorisations belongs,
while the other co- marketer is not a part of the group and both of them are
indicated as local representative in the territory.) The contemporary presence
of more than one marketer of a product, each one independent (i.e. not
linked by an agreement) from the originator of the dossier is not co- marketing.
On the other hand, an affiliation relationship between co- marketers implies
that they are considered, from a competition point of view, as the same business
organisation. Furthermore, a marketing authorisation generated by access to the
dossier without any agreement with the originator (as, for instance, when the
term of data protection has expired) is not co- marketing; nor does co-
marketing generate the perpetual assignment of the marketing authorisation
rights.
Regulatory
framework
EC pharmaceutical
legislation explicitly permits co- marketing. Chapter 1 (Marketing
Authorisation) of Volume 2A of the Notice to Applicants expressly provides
(paragraph 2.3) that:
in
cases where companies wish to market the same medicinal product with a second trade
name, then a separate application for a separate second authorisation must
be submitted. The European Commission must be informed of this intention in
advance.
Chapter 4 (Centralised
Procedure) of Volume 2A of the Notice to Applicants states (paragraph 3.1)
that a specific procedure has been agreed between the EMEA and the European
Commission; under this procedure companies should submit, at the latest four months
in advance, an explanation of the underlying motives of the multiple application
and their intentions as far as exploitation of any authorisation granted.
Relating to the mutual
recognition procedure, Chapter 2 (Mutual Recognition) of Volume 2A of
the Notice to Applicants states that the application for multiple marketing
authorisations for an identical medicinal product with a different name by the
same or a different marketing authorisation holder is possible. There is no
provision in EC pharmaceutical legislation that explicitly prohibits or imposes
restriction on the granting of separate marketing authorisations following
multiple applications. The Mutual Recognition Facilitation Group (MRFG) has
provided specific recommendations in order to facilitate and harmonise the
regulatory issues for submission of duplicate applications in mutual recognition
procedures2.
Co- promotion is not at
present explicitly provided for in the EC legislation. Co- promotion does not
involve a multiplication of marketing authorisations and the establishment by
the marketing authorisation holder of the scientific service in charge of
information about the medicinal products pursuant to Article 98 of
Directive 2001/83/EC is sufficient in order to have a responsible for the
information about the products even if promoted by a third party other than
the marketing authorisation holder3.
Lack of an explicit
discipline for co- promotion has resulted in a different approach by the Member
States. In Italy, for instance, promotion is permitted only for the marketing
authorisation holder or the company that, under an agreement with the marketing
authorisation holder, takes care of the distribution of the product across the
whole national territory4.
This rule, which was present in the Italian
legislation well before the implementation of Directive 92/28/EEC on the
advertising of medicinal products, in practice constitutes a prohibition of co-
promotion and has been a determining factor in the significant development of
co- marketing5.
The current draft of the
proposal of modifications to Directive 2001/83/EC provides for the
insertion of a paragraph 3 to Article 98, reading:
the
Member States shall authorise the co- promotion of a medicinal product by the
holder of the marketing authorisation and one or more companies named by him/her.
This would probably then
lead to the removal of the prohibition of co- promotion where this practice is
currently not allowed.
Competition issues
Co-marketing and co-
promo
ks, at the same price so
as to be included in a reimbursed products list (especially where public
healthcare systems are in a strong position because of the circumstance of the
monopolistic manager of the healthcare services also being the regulator of the
market.)
Articles 81(1) and
81(2) of the Treaty [formerly 85(1) and 85 (2)] prohibit and declare
null and void1:
all agreements between undertakings, decisions by
associations of undertakings and concerted practices which may affect trade
between Member States and which have as their object or effect the prevention,
restriction or distortion of competition within the common market, and in
particular those which:
(a)
directly or indirectly fix purchase or selling prices or any other trading
conditions;
(b)
limit or control production, markets, technical development, or investment;
(c)
share markets or sources of supply;
(d)
apply dissimilar conditions to equivalent transactions with other trading
parties, thereby placing them at a competitive disadvantage;
(e)
make the conclusion of contracts subject to acceptance by the other parties of
supplementary obligations which, by their nature or according to commercial
usage, have no connection with the subject of such contracts.
Pursuant to Article 81(3),
the provisions of paragraph 1 may, however, be declared inapplicable in the
case of any agreement or category of agreements, any decision or category of
decisions and any concerted practice or category of concerted practices which
contribute to improving the production or distribution of goods or to promoting
technical or economic progress, while allowing consumers a fair share of the
resulting benefit, and which does not: impose on the concerned undertakings
restrictions which are not indispensable to the attainment of these objectives;
or afford such undertakings the possibility of eliminating competition in
respect of a substantial part of the products in question.
Regulation No 19/65/EEC
as amended by Regulation (EC) No 1215/1999, empowers the Commission to
apply Article 81(3) of the Treaty by regulation to certain categories of
agreements and concerted practices falling within the scope of Article 81(1)6.
This includes categories of agreements which are entered into by two or
more undertakings, each operating, for the purposes of the agreement, at a
different level of the production or distribution chain ('vertical agreements'),
and which relate to the conditions under which the parties may purchase, sell or
resell certain goods or services. It also includes categories of agreements to
which only two subjects are party and which include restrictions imposed in
relation to the acquisition or use of industrial property rights (in particular
patents, utility models, designs or trademarks) or to the rights arising out of
contracts for assignment of, or the right to use, a method of manufacture or
knowledge relating to use or to the application of industrial processes.
The Commission has made
use of this power by adopting, over the years, a number of regulations, commonly
known as 'block exemption regulations'. The agreements falling in the scope of
said regulations are automatically exempted, while the agreements which are not
block exempted are to be expressly exempted by the Commission, if they meet the
conditions provided for in Article 81(3) of the Treaty. The present
situation of block exemption regulations, excluding the regulations specifically
applicable to a particular industry (e.g. car manufacturing, brewing)
consists of four regulations as follows:
Regulation (EC) No 2790/1999
of 22 December 1999 on the application of Article 81(3) of the Treaty
to categories of vertical agreements and concerted practices
This regulation is
complemented by guidelines on vertical restraints7,8.
As mentioned above, 'vertical' means that the concerned business organisations
operate at a different level of the production or distribution chain. The
regulation has been applicable since 1 June 2000 and has replaced three
block exemption regulations applying to exclusive distribution, exclusive
purchasing and franchising agreements. As the Commission itself elucidates, the
new rules embody a shift from the formalistic regulatory approach underlying the
previous legislation towards a more economic approach in the assessment of
vertical agreements under the EU competition rules. The aim of this new approach
is to simplify the rules applicable to supply and distribution agreements and to
reduce the regulatory burden, especially for companies lacking market power,
such as small to medium enterprises, while ensuring a more effective control of
agreements entered into by companies holding significant market power. The new
policy is based on a single regulation with a wide scope of application, which
block exempts supply and distribution agreements concerning final and
intermediary goods as well as services.
The new block exemption
regulation allows companies whose market share is below 30% to benefit from
a safe harbour under the Community competition rules. The share is referred to
the supplier, but in case of exclusive supply obligations, the share must be
referred to the buyer with respect to the market in which it purchases goods or
services. The safe harbour below 30% market share, offers companies the
freedom to create supply and distribution arrangements best suited to their
individual commercial interests and to adapt to changing economic conditions.
However, the block exemption regulation does not apply to the so- called hard
core restrictions. Two of them are particularly relevant to the area of co-
marketing and co- promotion:
-
a producer may not impose on its distributors
the price at which to resell its products (but maximum and recommended prices
are normally permissible); and
-
a producer may not restrict its distributors
from selling to any customer if it is an unsolicited order (passive sales); this
means that each distributor must be free to respond to a request for the product
or service made by any customer inside the Community.
These particular
restrictions to the competition game are prohibited in order to maintain free
price competition between distributors for the benefit of consumers and to
guarantee the consumers’ right to purchase goods and services wherever they
want inside the Community. These prohibition rules can also be applied directly
by national competition authorities and national courts; violations can attract
fines and give rise to claims of damages.
A second set of
restrictions not covered by the new Regulation 2790/1999 concerns certain
restrictions which are not exempted, but may under certain circumstances
nonetheless be compatible with EC competition rules. The most important of these
concerns non- compete obligations (requiring distributors to resell only the
brands of one supplier) when their duration exceeds five years. Such
agreements are not covered by the new block exemption regulation as they may
have a strong foreclosing effect on the market. The guidelines describe under
what circumstances long-term investments may justify a longer duration of
non-compete obligations.
Above the 30% market
share threshold, vertical agreements will not be covered by the new block
exemption regulation, but nor are they automatically presumed to be illegal.
They may require an individual examination under Article 81(3) of the
Treaty which spells out the conditions under which agreements between companies
may be exempted from EC competition rules. Companies in such a situation are
asked to make a self- assessment of the possible consequences of their vertical
agreements under the law. The guidelines assist companies in carrying out their
own assessment under the EC competition rules by explaining which vertical
agreements generally do not distort competition and therefore fall outside
Article 81(1).
Regulation (EC) No
2658/2000 of 29 November 2000 on the application of Article 81(3) to
categories of specialisation agreement
Regulation (EC) No
2659/2000 of 29 November 2000 on the application of Article 81(3) of
the Treaty to categories of research and development agreements
Regulations No 2658/2000
and 2659/2000 replace the former regulations on specialisation (Commission
Regulation (EEC) No 417/85) and R&D (Commission Regulation (EEC) No 418/85)9,10.
In comparison to the old regulations, the new texts are designed to be more
user- friendly, with greater clarity and an increased scope of application. The
new block exemptions replace the system of specifically exempted ‘white
list’ clauses by a general exemption of all conditions under which
undertakings pursue R&D and specialisation agreements. This move away from a
clause- based approach gives greater contractual freedom to the parties of such
agreements and removes the ‘strait-jacket’ imposed by the old regulations.
The combined market share threshold for exemption of all parties to an agreement
is set at 20% for specialisation agreements and at 25% for R&D
agreements. Beyond these market shares, R&D or specialisation agreements
will not automatically be prohibited but will have to be assessed individually.
However, hard core restrictions (price fixing, output limitation or allocation
of markets or customers) will generally remain prohibited, irrespective of the
parties’ market power.
R&D agreements and
specialisation agreements are horizontal agreements. The 'guidelines on the
applicability of Article 81 of the Treaty to horizontal co- operation
agreements' not only complement Regulations 2658/2000 and 2659/2000
referred to above, but also cover a wider range of the most common types of
horizontal agreements, for which Regulation 19/65/EEC does not provide the
possibility for a block exemption, and which therefore need to be
individually exempted on a case- by- case basis11,12.
The guidelines are applicable to R&D and production agreements not covered
by the block exemptions as well as to certain other types of competitor
collaboration e.g. joint purchasing, joint commercialisation. The
guidelines describe the general approach which should be followed when assessing
horizontal co- operation agreements and set out a common analytical framework.
This helps companies to assess with greater certainty whether or not an
agreement is restrictive of competition and, if so, whether it would qualify for
an exemption.
Commission
Regulation (EC) No 240/96 of 31 January 1996 on the application of
Article 85(3) [now 81(3)] of the Treaty to certain categories of technology
transfer agreements
This regulation covers
the classical patent and know- how license agreements and may be considered as
the last survivor of the old formalistic approach; it will remain in force until
31 March 200613.
Discussion
The first issue we
have to deal with in comparing co- marketing and co- promotion agreements with
the system of competition rules outlined above is whether they are to be
considered horizontal or vertical agreements; that is, to decide whether co-
promotion and co- marketing are agreements entered into by business
organisations operating at the same or a different level of the production or
distribution chain. But even before this, we have to ask ourselves if the two types
of agreement really differ in their intrinsic nature. In other words, are the
differentiation of trademarks and the fact that the normal common origin of a
product in terms of manufacturing, so important as to put the co- marketers at a
different level of the production/distribution chain, and, moreover, does the
difference in trademarks create a competitive relationship between the co-
marketers? 'Normal common origin of the product in manufacturing terms' implies
that one of the co- marketers sells the product directly to the subsequent level
of the chain (generally the wholesalers), while the other one purchases the
product or the active ingredient from the first co- marketer before selling
it (or before manufacturing and then selling it) to the wholesalers.
The following, for
instance, has been the decision of the antitrust authority of Italy (a country
where co- promotion is still not permitted) in a number of cases in 1999 where
co- marketers were heavily fined because the public price of co- marketed
products was the same. The Italian authority held that co- marketing was a
vertical distribution agreement and the differentiation in trademarks generated
a competitive relationship and so any concertation of prices was prohibited.
One proposal of
interpretation may be that co- marketing and co- promotion do not differ in
their essence and that the choice between co- marketing and co- promotion is a
result of regulatory constraints, more than of a real dissimilarity between the
economic nature of the agreements. In the recent Evaluation
of the operation of the community procedures for the authorisation of medicinal
products, the influence of regulatory rigidities on the conduct of business
in the EU is well depicted14.
For instance, according to the
report it would appear that there would be
greater use of the centralised procedure if it were more flexible in recognising
the commercial context in which many products are developed. The degree of
uniformity demanded to avoid partitioning of the market is viewed by companies
as unnecessary or disproportionate in light of the objectives at issue. There
continue to be major concerns about the requirement for a single trademark and
about labelling practice. Recently, the Court of First Instance (Judgement 3 July
2002, Case T- 179/00) held that the Commission erred in law in prohibiting
the inclusion of the logo of the marketing authorisation holder's local
representative in the blue box of the outer packaging of a medicinal product
authorised by centralised procedure by virtue of Article 2(2), Directive 92/27/EEC15,16.
In fact this kind of restriction is viewed as making it impossible to reflect
adequately the commercial interests of companies who have jointly developed
products and intend to market them through co- marketing or co- promotion
arrangements. On the other hand, the current regulatory prohibition of co-
promotion, in countries like Italy, necessarily leads to organising co-
operation as co- marketing.
It appears that the
purpose of co- marketing, as well as of co- promotion, is the acquisition by the
product originator of an additional force of penetration into the market,
consisting of the promotional resources (typically the medical representatives)
of the co- marketers, against a compensation leaving the co- marketer a
sufficient profit margin. The purpose of co- marketing is the performance by the
co- marketer of the promotional activity for the product which, even if
characterised by a different tradename, is perfectly identical to that of the
originator.
If providing door- to-
door information to the physician were not considered to be the main sales
driver, the originator would probably avoid a co- marketing arrangement. The
economic desirability of a co- marketer arises when the incremental costs of an
additional promotional force in the territory required to achieve a certain
increment in sales allowed by the market potential of the product exceed the
erosion of the margin on said additional revenues obtained through the co-
marketer due to the compensation owed him. Externalising promotional costs
allows the originator to be more efficient in connection with the additional
revenues, and permits the co- marketer to allocate, again with an improvement of
efficiency, available resources. This is conditional upon the price on which the
profit margin for the co- marketer is measured (normally a function of public
price) being not less than the efficiency level threshold. But said efficiencies,
through the price control systems which characterise almost all the European
countries, may be transferred to the last phase of the economic cycle. There are
two interesting consequences of this way of looking at co- marketing.
Firstly, all contractual relationships of a differing nature (license, supply,
technology transfer) are exclusively ancillary to co- marketing and aim at
creating the legal-regulatory situation allowing the co- marketer to promote the
product and the means by which the co- marketer is compensated for its activity.
Secondly, even the enjoyment of marketing authorisation or any other transfer of
regulatory rights is ancillary to the purpose of co- marketing; the originator
does not want to transfer its regulatory and intellectual property rights
surrounding the product, but entrust them with the co- marketer only for the co-
marketing term.
The conclusion is that
even if co- marketing encompasses supply or distribution arrangements, co-
marketing as well as co- promotion, is a horizontal and co- operative agreement.
Its evaluation under the competition rules must be made taking into account
first of all the existing competitive relationship, if any; co- marketing under
different tradenames is co- operation aiming at the joint promotion, not of the
products respectively belonging to the parties, but all of them belonging to the
originator, and some of which are entrusted for the promotion and sale with the
co- marketer.
The core of co- marketing
is promotion. Supply of the active ingredient or the product (which do not
necessarily come from the originator, but may come from different subjects which
also manufacture and supply them to the originator) are ancillary. Irrespective
of the supply or distribution arrangements, co- marketers operate to the same
level of the economic cycle i.e. the level at which the ex-factory price is
formed. Construing compensation of the co- marketer as a direct compensation for
the service (e.g. a percentage of sales generated by the co- marketer),
instead of as a margin between the purchase and resale price, is not forbidden
and is another way of arranging the business relationship.
According to the
guidelines on horizontal agreements, those agreements closer to the downstream
end of a product's economic cycle are commercialisation agreements dealt with by
Section 5 of the guidelines12.
These agreements can vary widely in scope, depending on the marketing functions
being covered by the co- operative efforts. At one end of the spectrum, there is
joint selling leading to a joint determination of all commercial aspects related
to sale of the product, including price. At the other end, there are more
limited agreements that only address one specific marketing function such as
distribution, service or advertising. Price fixing, the guidelines observe, can
generally not be justifiable unless it is indispensable to the integration of
other marketing functions and this integration will generate substantial
efficiencies. The size of the efficiencies generated depends inter
alia on the importance of the joint marketing activities to the overall cost
structure of the product in question. Joint distribution is thus more likely to
generate significant efficiencies for producers of widely distributed consumer
products which are only bought by a limited number of users.
Of course, these
statements from the guidelines can't be taken as a sort of general authorisation
to price agreements. However, in the framework of a co- operative horizontal
agreement which does not affect previous competitive relationships, aimed at the
acquisition of promotional services on an undifferentiated product, is the
common determination of price still to be considered anti-competitive? The
product remains in the beneficial ownership of the originator and is just
entrusted with the co- marketer in order to be promoted and, often necessarily
as a regulatory constraint, distributed. Rather than a forbidden concertation, a
unique price appears to be a transparency obligation in a regulated market,
where the price regulation mechanism permits the transfer to the consumer of the
benefits arising from co- marketing.
Further comments
and conclusion
If there is an
imperfection, we can find it not in the alteration of the competitive game, but
in the substantial weakness of the co- promotion and co- marketing arrangements
as they are generally practised in Europe, when looked at as tools able to
strengthen the competitiveness of the European industry.
A report prepared in
November 2000 for the Enterprise Directorate General of the European Commission
by a group of scholars from leading Italian academies confirms that no company
is now able to control and master internally all the knowledge required to
discover and develop a new drug17.
The ability to access and make efficient use of a network of collaborative
relations and the underlying market for technology, the report says, has
therefore become a crucial source of competitiveness. Such co- operation may
take place between companies and academic institutions, pure research
organisations or new biotechnology firms as technology suppliers, as well as
between companies themselves engaged in all the phases of the economic cycle (research,
development, manufacturing and marketing).
According to the report,
US firms have consistently over time demonstrated the highest propensity to
collaborate in the pre-clinical phase, whereas collaboration in marketing
remains significant in the European countries. Furthermore, US firms act more
frequently as licensors (originators) of new R&D projects as compared to
European countries, which are typically licensees (developers). Firms located in
countries like Italy and, to a lesser extent, Sweden, have a high propensity to
license- in in the latter phases of the R&D chain from the US, while UK and
Swiss firms also collaborate extensively in the early stages of the R&D
process. Moreover the role of 'originators' of US and Canadian companies is
linked to the disproportionate share of licences which involve, largely as
licensors, new biotechnology firms, universities and other research centres, as
compared to the other major European countries (with the exception of the
Netherlands, Denmark and Sweden) and Japan.
The
report suggests that one major difference between the US and Europe is the
presence in the US of an industry of technology suppliers, both new
biotechnology firms and universities. In short, Europe and the US may not appear
too different if one looks individually at the large drug multinationals; but
they do appear different if one looks at the organisation of the industry. In
the US there is not only a larger number of big innovative companies, but also a
higher supply of new technologies and an extensive vertical specialisation
between an industry that is specialised in the 'exploration' of new technologies
and innovation opportunities and an industry that is specialised in their 'exploitation'.
The
European research system needs not only to be strengthened in terms of its
ability to produce more and better research, but also to exploit its innovation
potential by translating this potential into economic performance. The US
competitiveness in drug innovation appears to be the sum of these two effects
of better in- house capabilities and more effective use of the market for
technology; European firms lag behind their US counterparts in terms of their
in- house capabilities and, moreover, in the extent of their use of the market
for technology.
Co-
operation among European companies appears to be a necessity in order to develop
a domestic research system through a division of innovative labour and to
increase the productivity of their research as well as to gain access to
external knowledge from specialist technology suppliers without the mediation of
US companies. Co- operation may involve the early
phases of research and development or it may be more marketing oriented.
The typical format of an
agreement between a technology supplier and a pharmaceutical company is a
technology transfer, whereby the consideration for the technology supplier is in
terms of lump sum or royalties or a combination of both. When the co- operating
companies are fully engaged in the entire stream of the product life, down to
the marketing phase, they tend to have their reward from the market in terms of
revenue from sales. In such cases, the co- promotion or the co- marketing of the
product by the companies engaged in the co- operative agreement is the result
and the contents of their agreement. A co- marketing or a co- promotion
agreement made at the earliest stages of product development not only appears to
be a key success factor in the competitive game, but it is more likely to fall
under the scope of the block exemption regulation No 2659/2000 as it is
related alternatively to:
·
joint research and
development of products or processes and joint exploitation of the results of
that research and development; or
·
joint exploitation of the
results of research and development of products or processes jointly carried out
pursuant to a prior agreement between the same parties.
The efficiencies
generated will not simply be the avoidance of the ‘cost of competition’, but,
as the EC guidelines require, real savings resulting from the integration of
economic activities.
The environment of the
pharmaceutical industry has been rapidly changing since the last decade of the
last century. Co- marketing and co- promotion as a tool for non- European
companies to gain access to those national markets particularly protected from a
regulatory point of view are no longer in line with the new environment.
Innovation is confirmed as the arena in which the competitive contest will be
decided. The future of co- marketing and co- promotion may be co- research and
co- development between European companies.
References
1.
Consolidated version of The Treaty establishing the European Community as
amended by The Treaty of Amsterdam (signed 2 October 1997), OJ,
1997, C340, 173-308
2.
MRFG, Recommendations on Multiple Applications in Mutual Recognition
Procedures, Final Version, 28 May 1999, available via website http://heads.medagencies.org/
3.
Directive 2001/83/EC of the European Parliament and of the Council
of 6 November 2001 on the Community code relating to medicinal products for
human use, OJ, 2001, L311,
67- 128
4.
Legislative Decree No 541/1992, Gazzetta
Ufficiale della Repubblica Italiana (GURI), 11 January,
1993, 7, supplement, as amended by Legislative Decree No 44/1997,
GURI, 6 March, 1997, 54, supplement
5.
Council Directive 92/28/EEC of 31 March 1992 on the advertising of
medicinal products for human use, OJ, 1992,
L113, 13-18
6.
Council Regulation (EC) No 1215/1999 of 10 June 1999
amending Regulation No 19/65/EEC on the application of Article 81(3)
of the Treaty to certain categories of agreements and concerted practices, OJ,
1999, L148, 1-4
7.
Commission Regulation (EC) No 2790/1999 of 22 December 1999 on
the application of Article 81(3) of the Treaty to categories of vertical
agreements and concerted practices, OJ,
1999, L336, 21-25
8.
Commission Notice 2000/C 291/01, Guidelines on vertical
restraints, OJ, 2000, C291,
1-44
9.
Commission Regulation (EC) No 2658/2000 of 29 November 2000 on the
application of Article 81(3) of the Treaty to categories of specialisation
agreements, OJ, 2000, L304,
3-6
10.
Commission Regulation (EC) No 2659/2000 of 29 November 2000 on
the application of Article 81(3) of the Treaty to categories of research
and development agreements, OJ,
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