Counterfeiting of pharmaceutical products under the EU law and relevant jurisdictional practice

Author:Marius Pantea
Position:PhD, Lecturer - Faculty of Police, 'Alexandru Ioan Cuza' Police Academy, Bucharest
Pages:1-18
1
COUNTERFEITING OF PHARMACEUTICAL PRODUCTS UNDER THE
EU LAW AND RELEVANT JURISDICTIONAL PRACTICE
*)
Marius Pantea
**)
Abstract
Throughout the article, the author brings forward the main characteristics of
intellectual property law touching the pharmaceutical industry, the provisions of
European Union (EU) law and the practical arrangements for the protection of
medicines and other pharmaceuticals, international and regional bodies involved
in the process of registration and protection of patent in the abovementioned field,
important statistical aspects of the counterfeiting of medicines and medical
devices. The end of the article highlights the EU strategy in the field of protecting
pharmaceutical products and objectives of EU institutions specialized in
combating such criminal activities.
Keywords: intellectual property law; counterfeiting; pharmaceuticals; e-commerce
Preamble
Inventiveness and creativity are essential features that favoured human
differentiation, during its evolution, from all other living creatures. The ability to
give these features a productive use remains fundamentally paramount in social
and economic structures of human society. Survival of every single man, of each
enterprise, organization or even nations clearly depends on the ability to keep
permanent contact with the development and progress in all fields.
Intellectual property includes legal rights ensuing from intellectual creation
activities in the following areas: industrial, scientific, literary or artistic, and
impossibility of protection by mere possession of the intellectual property object
stands for the basis of the whole concept of legal regulations on such property,
designed to protect creators and other producers of goods and services on account
of time-limit assignment of the right to use such works or services
1)
. Intellectual
property rights are outlined in Article 27 of the Universal Declaration of Human
Rights, which stipulates that „everyone has the right freely to participate in the
cultural life of the community, to enjoy the arts and to share in scientific
advancement and its benefits ... Everyone has the right to the protection of the
moral and material interests resulting from any scientific, literary or artistic
*)
Article translated from the Romanian language by Cerasela Gheorghe (Casa de traduceri).
**)
PhD, Lecturer – Faculty of Police, „Alexandru Ioan Cuza” Police Academy, Bucharest;
email; marius.pantea@academiadepolitie.ro.
1)
See M. Pantea, ProtecŃia penală a proprietăŃii intelectuale în era globalizării (Criminal
Protection of Intellectual Property in the Era of Globalization), Expert Publishing House,
Bucharest, 2008, p. 18.
2
production of which he is the author” and in the EU Charter of Fundamental
Rights, which clearly stipulates in Article 17 par. 2 that „intellectual property shall
be protected”
2)
.
In the era of globalization of trade and communications, industry digitization,
the unprecedented development of information systems, intellectual property
protection is a challenge for democratic governments and international vocation
bodies. The various forms taken by the intellectual property were always based
and are still based on economic interests and „counterfeiting has become a
thriving industry, which may even kill and whose flagship is China”, according to
the European Commission’s statements, which challenged Member States of the
European Union (hereinafter EU) to combat this phenomenon
3)
.
Large sums of money invested in the industrial logistics by criminal
organizations with the view to increase both quality and quantity of current
production allow counterfeit products to be manufactured, which are increasingly
harder to be detected. In some countries, there were built real industrial parks
specialized in the manufacture of counterfeit goods, where the goods sold are
actually fake. The price of a counterfeit product can sometimes be higher than the
price of an original one, so as not to attract attention of the authorities or holders
of rights. At present, involvement of international criminal organizations in global
trafficking of counterfeit goods is a certainty, often being used for this purpose all
legal instruments for the import and export of such products.
„Counterfeit industry of pharmaceuticals” has become lately more profitable
than illegal drug trafficking as organized crime groups operate, generally,
similarly with any economic agent provider of services or manufacturer of
material goods, aiming to increase their earnings and with the view to reduce the
volume of the total gross income expenses. Crime in the area of intellectual
property rights has become a global problem, has a strong cross-border character,
its negative effects often involving serious violations of human rights and
fundamental freedoms, financial losses and economic damage to states,
endangering people’s life and health, being a threat to national security of states,
and potentially having a devastating effect on human society.
1. Agreement on intellectual property rights related to trade. On the subject
of pharmaceuticals, it all started from the premise that their protection is an
economic incentive to develop research and innovation in the field. Economic
reasons behind the rationale of this type of protection justified costs and benefits
and led to a proposal for international regulation embodied in the Agreement on
2)
Published in the „Official Journal of the European Union” C 303 / 1 of December 14
th
,
2007 (see http://eur-lex.europa.eu/ro/treaties/dat/32007X1214/htm/C2007 303RO.01000101.htm).
3)
European Commission: The counterfeiting industry can kill and must be abolished, article
published on the site Ziare.com, March 10
th
, 2008 (see http://www.ziare.com/articole/medicamente-
contrafacute).
3
Trade-Related Aspects of Intellectual Property Rights (TRIPS)
4)
. This established
at international level a legal mechanism allowing all member countries to have
access to both new patent-protected drugs, and especially in generic medicines.
A brief history of the emergence of the Agreement on Trade-Related Aspects of
Intellectual Property Rights sends us back to the 80s of last century as starting point,
when the acceleration of globalization in the field of intellectual property rights
through international trade, foreign direct investment and licensing led to a situation
of conflict between protection standards of these rights at the relevant time and
needs incurred due to the economic circumstances of the time. This situation
worsened during the 90s of the twentieth century, as the need to sell products
covering intellectual property rights internationally has become increasingly
inappropriate with the arrangements for the protection of inventions and existing
trademarks, strictly based on national or regional laws and regulations.
The United States of America initially endorsed at the Ministerial Conference in
1982 the establishment of an international code of counterfeit goods, but the initiative
was not viewed with much enthusiasm by the other Member States. Negotiations on
the launch of the Uruguay Round lasted almost as long as negotiations for the entire
Tokyo Round. The United States of America attempted to launch a round of
negotiations since the early 80s, due to unsatisfactory results of the Tokyo Round.
Inclusion of new areas, among which pharmaceuticals, in the Uruguay Round was
entirely a U.S. initiative, being driven by the interests of multinational companies in
this country. In terms of intellectual property area, the main stimuli were brought by
the pharmaceutical, software and entertainment industries.
The Agreement sets down general standards in relation to each of the main
areas of intellectual property accepted. There are thus established minimum
standards of protection that are to be offered by each member, characterized as an
agreement allowing members to provide greater protection of intellectual
property, in as far as Member States are free to determine the most appropriate
implementation method of the agreement, in compliance with their own legal
system and relevant policies. It also allows Member States to provide some
options for the definition of recipients and national treatment, provided these
issues shall be notified to the Council of the Agreement on Trade-Related Aspects
of Intellectual Property Rights.
Most significant amendments to the above-mentioned document on
intellectual property are in the field of patents, given the controversies relating to
technology protection. Article 27 of the Agreement provides a broad definition of
processes, products likely to be patented: patents shall be available for any
inventions, whether products or processes, in all fields of technology, provided
4)
The Agreement on Trade-Related Aspects of Intellectual Property Rights is an agreement concluded
among all WTO members, establishing protection and enforcement of intellectual property rights. Trade-
Related Aspects of Intellectual Property Rights is the most comprehensive multilateral agreement on
intellectual property to date (see http://www.microsoft.com/romania/antipiracy/informlegale.mspx).
4
that they are new, involve an inventive step and are capable of industrial
application. The Agreement prohibits discrimination in relation to the use of
rights conferred by patents between imported and locally produced products.
Patents shall be available as to the place of innovation, the field of technology and
whether products are imported or locally produced. Therefore, many countries
need to expand the level of patent protection in major technological fields, like the
pharmaceutical, chemical and food industries. Member States shall enjoy
flexibility in defining the conditions for protection, establishment of these
conditions standing at the discretion of each country. Developing countries may
opt for high standards of novelty and to determine whether an invention can be
patented or not, although the usefulness of such excessive demand as compared to
usual practice may be extremely low. Authorities in the field can be prepared to
recognize only the restrictive demands to promote the ability of competitors to
invent around patents. Likewise, there are provided exemptions from
patentability, designed to protect public order or morality, to prevent
environmental damage, to protect the lives of people and animals and preserve
vegetation. These exceptions are limited by the provision under which „members
may provide exceptions limited to exclusive rights conferred by a patent, provided
that they do not unduly prejudice the normal exploitation of the patent or cause
undue harm to lawful interests of patent owner, bearing in mind the legitimate
interests of third parties” (Article 30). In practice, it allows states to provide
limited use for private and non-commercial purposes, research, experimentation or
teaching purposes and for the preparation of certain medicines by pharmacies. It can
also be raised in the approval of generic medicines. There can also be excluded
from patentability diagnostic, therapeutic and surgical methods. The most
controversial is the exception
5)
relating to biotechnological inventions, which in
principle are patentable, and patents should be given to micro-organisms and
microbiological processes. However, unlike the strong protectionist U.S. approach,
the Agreement on Trade-Related Aspects of Intellectual Property Rights permits the
exclusion from patentability of essentially biological processes for the production of
plants or animals and plants and animals other than micro-organisms.
In addition to expanding coverage of patents, including pharmaceuticals, the
agreement strengthens the purpose of rights conferred, recognizes the exclusive
right of import, although many experts argue that this right was implicative to the
right to offer for sale. Since the obligations on the use of patents in domestic
production of medicines are no longer valid, these can not be used to justify
compulsory licensing. However, the right of import is explicitly limited.
5)
Article 27.3 of the Agreement on Trade-Related Aspects of Intellect ual Property Rights (see
http://www.dce.gov.ro/Materiale%20site/texte_ref/ACORD_PRIVIND_ASPECTELE_DREPTUR
ILOR_DE_PROPRIETATE_INTELECTUALA.html).
5
It is important to note the fact that the holder of a patent in the pharmaceutical
area has the opportunity to decide how to use it and submit it. Likewise, the
agreement establishes an obligation to disclose this type of invention so that to
fulfil the original purpose, namely to boost the innovative process in the health
area, resulting in economic growth. This provision ensures that the company fully
benefits of the gains of the relevant invention in the pharmaceutical field, as well
as of the possible economic implications of that patent. Member States may allow
unauthorized use of patented inventions under certain conditions, as long as those
exceptions do not unreasonably interfere with the exploitation of patents and do
not unreasonably prejudice the legitimate interests of the patent holder. In
practice, it allows states to provide limited use for private and non-commercial
purposes, research, experimentation or teaching and for the preparation of certain
medicines by pharmacies. This provision may also be appealed to in the generic
drug approval. There are set new limits on the use of compulsory licenses for
patented information, but it is recognized their partly utility as means to stimulate
competition with the view to ensure access to technology.
The Agreement provides ample opportunities to specify conditions for the use
of compulsory licenses, keeping up a compromise between those who develop
technology and potential users. Significantly, compulsory licenses are not
territorially limited, so that rights afforded by pharmaceutical patents are not
abused. On these lines there may be issued non-exclusive and non-assignable
licenses where patent holders have failed within a normal period of time to
negotiate voluntary licenses, those interested providing commercially reasonable
terms. Licenses shall be used mainly for domestic markets, in order to protect the
interests of right holders abroad. Holder by right must be given adequate
remuneration, based on economic value of authorized use. Also, authorities can
issue compulsory licenses in order to allow use of dependent patents for which
operation is related to access to protected technology by virtue of a previous patent.
However, such licenses are exclusively allowed when the second patent is an
important technological advance, with considerable economic significance to the
first patent. Conditions listed above were considered strict safeguards
6)
. However,
some crucial conditions are totally dependent on the purposes and merits of such
agreements. They provide a significant possibility of choice for economic policy
makers from developing countries in order to build legal foundations, making sure
that these conditions do not become too restrictive. An example is the distribution
of patented pharmaceutical products through public hospitals or health centres on
non-commercial grounds, ensuring access to those who can not afford buying them,
though need them. Pharmaceutical patent legislation in some developed countries
6)
See Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (see
http://www.dce.gov.ro/Materiale%20site/texte_ref/ACORD_PRIVIND_ASPECTELE_DREPTURILO
R_DE_PROPRIETATE_INTELECTUALA.html).
6
and developing countries contains such provisions, although only Canada actually
uses this tool extensively for pharmaceutical products.
The agreement unifies coverage of patent protection granted to
pharmaceutical products for a minimum term of protection of 20 years since its
first embodiment. Moreover, in case of alleged infringement of pharmaceutical
patent holders’ rights, the burden of proof is reversed, being placed with the
defendant that is to demonstrate that its product or process for obtaining a
pharmaceutical product does not infringe patent held by the accuser
7)
. This has
lately become the general rule in many industrialized countries, where it is
recognized the fact that the demonstration of process violation is difficult and
therefore the procedure requires amendment in patent law in many developing
countries, but also in some developed countries.
2. EU legislation in the field of pharmaceuticals protection, taking over all the
provisions of the Agreement on Trade-Related Aspects of Intellectual Property
Rights
8)
, includes the following regulations:
Protocol amending the TRIPS Agreement
9)
European Patent Convention done at Munich in 1973
10)
and its Revision
Act, adopted in 2000
11)
. The regulation allows inventors to obtain a single patent,
encourages innovation, promotes a unified and clear legal framework and
provides financial facilities in the area by reducing the costs of registration.
European patent term is 20 years from the actual date of filing the application
12)
;
Regulations to the European Patent Convention, adopted by the
Administrative Council, setting forth the instituting of the European Patent Office
in The Hague and the procedures for obtaining a European patent
13)
;
7)
Under certain conditions, according to Article 34.1 of the Agreement on Trade-Related Aspects of
Intellectual Property Rights (see http://www.dce.gov.ro/Materiale%20site/texte_ref/ACORD_PRIVIND_
ASPECTELE _DREPTURILOR _DE_PROPRIETATE_INTELECTUALA.html).
8)
Done at Marrakech on April 15
th
, 1994, ratified by Romania on December 22
nd
, 1994 by
Law no. 133/1994 published in the „Official Gazette of Romania”, Part I, no. 360 of December
27
th
, 1994 (see http://www.osim.ro/legis/marci/lege133.htm).
9)
Published in the „Official Journal of the European Union” L 311 37 of November 29
th
, 2007
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:311:0037:0041:RO: PDF).
10)
See M. Uban, L. Antoniu, E. Bondar, ConvenŃia brevetului european (European Patent
Convention), OSIM Publishing House, Bucharest, 2004.
11)
Romania joined by Law 611/2002, published in the „Official Gazette of Romania”, Part I,
no. 844 of November 22
nd
, 2002 (see http://www.osim.ro/legis/brevet/leg611.html).
12)
Date referred to in Article 53 point c of the Convention on the Grant of European Patents (see http://
www.tehimpuls.ro/files/File/Legislatie/conventia%20brevetului%20european%20%28traducere%29.pdf).
13)
Decision 2011/167/EU of the Council of March 10
th
, 2011 authorizing enhanced
cooperation in the area of the creation of unitary patent protection, published in t he „Official
Journal of the European Union” OJ L 76/53 of March 22
nd
, 2011 (see http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:076:005 3:0055:ro: PDF).
7
Directive 98/44/EC of the European Parliament and of the Council on the
Legal Protection of Biotechnological Inventions
14)
, which establishes patent
protection of products consisting of or containing biological material, and
processes which produce, process or use biological material. Equally, it protects
biological material isolated from its natural environment or produced by means of
a technical process, even if it previously occurred in nature. Inventions related to
plants or animals shall be patentable if the technical feasibility of the invention is
not limited to a particular variety of plant or animal. There is also protected an
element isolated from the human body or produced in another way through a
technical process, including the sequence or partial sequence of a gene, even if the
structure of that element is identical to that of a natural element
15)
;
Council Decision of 1975 setting up a Pharmaceutical Committee
16)
, which
establishes the obligation to consult the Committee for Proprietary Medicinal
products when the latter shall draw up proposals for directives in the field;
Convention on the elaboration of a European Pharmacopoeia
17)
, common
to the countries concerned, undertaken by the „Public Health Committee” of the
Council of Europe aimed at the preparation and adoption of monographs to be
included in the „European Pharmacopoeia”;
Protocol to the Convention on the elaboration of a European
Pharmacopoeia 1994
18)
;
Regulation (EC) No. 297/95 of the Council on fees payable to the
European Agency for the Evaluation of Medicinal Products
19)
;
Commission Regulation (EC) No. 540/95 of March 10
th
, 1995 laying
down the arrangements for reporting suspected unexpected adverse reactions
which are not serious, whether arising in the Community or in a third country, to
14)
Published in the „Official Journal of the E uropean Union” 'L 213/13 of July 30
th
, 1998 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:2 13:0013:0021:EN:PDF).
15)
See C. Voicu et al., etc., Securitatea Financiară a Uniunii Europene în viziunea Tratatului
de la Lisabona (Financial Security of the European Union under the Lisbon Treaty), vol. II, Pro
Universitaria Publishing House, Bucharest, 2010, p. 81.
16)
Published in the „Official Journal of the European Union” L 147/23 of June 9
th
, 1975 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3197 5D0320:RO:HTML).
17)
Published in the „Official Journal of the European Union” L 158/19 of June 25
th
, 1994 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:21994A0625%2802%29:RO:HTML).
18)
Published in the „Official Journal of the European Union” L 35 of February 15
th
, 1994 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995R0297:RO:HTML) as amended
by Commission Regulation (EU) No. 301/2011 of March 28
th
, 2011 amending Council Regulation (EC)
No. 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32011R0301:RO:HTML).
19)
Published in the „Official Journal of t he European Union” L 158/19 of June 25
th
, 1994 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3199 5R0297:RO:HTML).
8
medicinal products for human or veterinary use authorized in accordance with
the provisions of Council Regulation (EEC) No. 2309/93
20)
;
Commission Regulation (EC) No. 540/95 laying down the arrangements
for reporting suspected unexpected adverse reactions which are not serious,
whether arising in the Community or in a third country, to medicinal products for
human or veterinary use authorized in accordance with the provisions of Council
Regulation (EEC) No. 2309/93
21)
;
Commission Regulation (EC) No. 1662/95 laying down certain detailed
arrangements for implementing the Community decision-making procedures in
respect of marketing authorisations for products for human or veterinary use
22)
;
Regulation (EC) No. 1610/96 of the European Parliament and of the
Council concerning the creation of a supplementary protection certificate for plant
protection products
23)
;
Commission Regulation (EC) No. 2141/96 concerning the examination of
an application for the transfer of a marketing authorization for a medicinal product
falling within the scope of Council Regulation (EC) No. 2309/93
24)
;
Directive 2001/20/EC of the European Parliament and of the Council on
the approximation of the laws, regulations and administrative provisions of the
Member States relating to the implementation of good clinical practice in the
conduct of clinical trials on medicinal products for human use
25)
;
Directive 2001/82/EC of the European Parliament and of the Council on
the Community code relating to veterinary medicinal products
26)
;
20)
Published in the „Official Journal of the European Union” L 55 of March 11
th
, 1995 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3199 5R0540:RO:HTML).
21)
Published in the „Official Journal o f the E uropean Union” JO L 214 of August 24
th
, 1993
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:319 95R0540:RO:HTML).
22)
Published in the „Official Journal of the European Union” L 158/4 of July 8
th
, 1995 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3199 5R1662:RO:HTML).
23)
Published in the „Official Journal o f the E uropean Union” L 198 of August 8
th
, 1996 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3199 6R1610:RO:HTML).
24)
Published in the „Official Journal of the European Union” L 2 86 of November 8
th
, 1996
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:319 96R2141:RO:HTML).
25)
P ublished in the „Official Journal of the European Union” L 121 of Ma y 1
st
, 2001 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:3 11:0001:0066:RO:PDF), as
amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council of June
18
th
, 2009 ad apting a number of instruments subject to the procedure referred to in Article 251 o f
the Treaty to Council Decision 1999/468/EC with regard to the regulator y procedure with scrutiny
- Adaptation to the regulatory procedure with scrutiny - Part Four, published in the „Official
Journal of the European Union” OJ L 188 of July 18
th
, 2009 (see http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:188:001 4:0092:RO:PDF).
26)
Published in the „Official Journal of the European U nion” L 311 of November 28
th
, 2001
(see http://eur-lex.e uropa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:1 21:0034:0044:RO:PDF),
as amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council of
June 18
th
, 2009 adapting a number of instruments subject to the procedure referred to in Article
251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with
9
Directive 2001/83/EC of the European Parliament and of the Council on
the Community code relating to medicinal products for human use
27)
;
Commission Directive 2003/94/EC laying down the principles and
guidelines of good manufacturing practice in respect of medicinal products for
human use and investigational medicinal products for human use
28)
;
Regulation (EC) No. 726/2004 of the European Parliament and of the
Council laying down Community procedures for the authorization and
supervision of medicinal products for human and veterinary use and establishing
a „European Medicines Agency”
29)
;
Commission Directive 2005/28/EC laying down principles and detailed
guidelines for good clinical practice as regards investigational medicinal
products for human use, as well as the requirements for authorisation of the
manufacturing or importation of such products
30)
;
Commission Regulation (EC) No. 2049/2005 laying down, pursuant to
Regulation (EC) No. 726/2004 of the European Parliament and of the Council,
rules regarding the payment of fees to, and the receipt of administrative
assistance from, the „European Medicines Agency” by micro, small and medium-
sized enterprises
31)
;
Commission Directive 2006/130/EC implementing Directive 2001/82/EC
of the European Parliament and of the Council as regards the establishment of
criteria for exempting certain veterinary medicinal products for food-producing
animals from the requirement of a veterinary prescription
32)
;
scrutiny – Adaptation to the regulatory procedure with scrutiny – Part Four, published in the
„Official Journal of the European Union” OJ L 188 of July 18
th
, 2009 (see http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:188:001 4:0092:RO:PDF).
27)
Published in the „Official Journal of the European U nion” L 311 of November 28
th
, 2001
(see http://eur-lex.e uropa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:3 11:0067:0128:RO:PDF),
as amended by Directive 2010/84/EU of the European Parliament and of the Council of December
15
th
, 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community
code relating to medicinal products for human use, published in t he „Official Journa l of the
European Union” L 348 of December 31
st
, 2010 (see http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32010L0084 :RO:PDF).
28)
Published in the „Official Journal of the European Union” L 2 62 of October 14
th
, 2003 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:2 62:0022:0026:RO:PDF).
29)
Published in the „Official Journal of the European Union” L 136 of April 30
th
, 2004 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:1 36:0001:0033:RO:PDF).
30)
Published in the „Official Journal of the European Union” L 91 of April 9
th
, 2005 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:0 91:0013:0019:RO:PDF).
31)
Published in the „Official J ournal of the European Union” L 329 of December 16
th
, 2005
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005 :329:0004:0007:RO:PDF).
32)
Published in the „Official J ournal of the European Union” L 349 of December 12
th
, 2006
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:320 06L0130:RO:HTML).
10
Commission Regulation (EC) No. 507/2006 on the conditional marketing
authorisation for medicinal products for human use falling within the scope of
Regulation (EC) No. 726/2004 of the European Parliament and of the Council
33)
;
Regulation (EC) No. 816/2006 of the European Parliament and of the
Council on compulsory licensing of patents relating to the manufacture of
pharmaceutical products for export to countries with public health problems
34)
;
Commission Regulation (EC) No. 1950/2006
35)
establishing, in
accordance with Directive 2001/82/EC of the European Parliament and of the
Council on the Community code relating to veterinary medicinal products, a list
of substances essential for the treatment of equidae
36)
;
Commission Regulation (EC) No. 658/2007 concerning financial penalties
for infringement of certain obligations in connection with marketing
authorisations granted under Regulation (EC) No. 726/2004 of the European
Parliament and of the Council
37)
;
Regulation (EC) No. 1394/2007 of the European Parliament and of the
Council on advanced therapy medicinal products and amending Directive
38)
;
Commission Decision 2008/911/EC establishing a list of herbal
substance, preparations and combinations thereof for use in traditional herbal
medicinal products
39)
;
Commission Regulation (EC) No. 1234/2008 concerning the examination
of variations to the terms of marketing authorisations for medicinal products for
human use and veterinary medicinal products
40)
;
33)
Published in the „Official Journal of the European Union” L 92 of March 30
th
, 2006 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3200 6R0507:RO:HTML).
34)
P ublished in the „Official Journal of the European Union” L 157 of June 9
th
, 2006 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3200 6R0816:RO:HTML).
35)
Published in the „Official Journal of the European Union” L 367 of December 22
nd
, 2006 (a
se vedea http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1950:RO:HTML).
36)
Solipeds (odd-toed ungulate) mammal family, including horse, d onkey, zebra, etc., (In sg .)
animal in this family. [Sg. ecvide u. / équidés, cf. Lat. equus Horse], see
http://dexonline.ro/definitie/ecvideu.
37)
Published in the „Official Journal of the European Union” L 155 of June 15
th
, 2007 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3200 7R0658:RO:HTML).
38)
Published in the „Official Jo urnal of the European Union” L 324 of December 10
th
, 2007
amended by Commission Regulation (EU) No. 1235/2010 of the European Parliament and of the
Council of December 15
th
, 2010 amending, as regards pharmacovigilance of medicinal products for
human use, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and establishing a European
Medicines Agency, and Regulation (EC) No. 1394/2007 on advanced therapy medicinal products
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX: 32010R1235:RO:NOT).
39)
Published in the „Official Journal of the Euro pean Union” L 328 of December 6
th
, 20 08
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:320 08D0911:RO:HTML).
40)
Published in the „Official J ournal of the European Union” L 334 of December 12
th
, 2008
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:320 08R1234:RO:HTML).
11
Directive 2009/35/EC of the European Parliament and of the Council on
the colouring matters which may be added to medicinal products
41)
;
Regulation (EC) No. 469/2009 of the European Parliament and of the
Council concerning the supplementary protection certificate for medicinal
products
42)
;
Commission Regulation (EC) No. 668/2009 implementing Regulation
(EC) No. 1394/2007 of the European Parliament and of the Council with regard
to the evaluation and certification of quality and non-clinical data relating to
advanced therapy medicinal products developed by micro, small and medium-
sized enterprises
43)
;
Protocol amending the Agreement on Trade-Related Aspects of
Intellectual Property Rights, which specifies important pharmaceutical
regulations, reaffirmed by the Declaration on the Agreement on Trade-Related
Aspects of Intellectual Property Rights and Public Health
44)
. Annex to this
protocol defines the „pharmaceutical product” as „any patented product, or
product manufactured through a patented process, of the pharmaceutical sector
needed to address the public health problems”.
3. International and regional bodies. Among international and regional
vocation organizations with authority in managing issues on the patent granted for
pharmaceuticals range:
3.1. World Trade Organization (WTO), which was created on January 1
st
,
1995 to implement the „Agreement on Trade-Related Aspects of Intellectual
Property Rights” and to replace the „General Agreement on Tariffs and Trade”
(GATT)
45)
, which included a series of commercial treaties concluded at the end of
World War II in order to facilitate free trade. Principles of the „General
Agreement on Tariffs and Trade” were adopted by the World Trade Organization,
which was responsible for administering and expanding them. Unlike the
„General Agreement on Tariffs and Trade”, World Trade Organization has a
substantial institutional structure. Effectively, the World Trade Organization is the
successor of the much delayed International Trade Organization (ITO), which
was originally planned to be successor of the General Agreement on Tariffs and
Trade. The International Charter for the International Trade Organization was
41)
Published in the „Official Journal of the European Union” L 109 of April 30
th
, 2009 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3200 9L0035:RO:HTML).
42)
Published in the „Official Journal of the European Union” L 152 of June 16
th
, 2009 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3200 9R0469:RO:HTML).
43)
Published in the „Official Journal of the European Union” L 194 of July 25
th
, 2009 (see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:3200 9R0668:RO:HTML).
44)
Text adopted by the European Parliament in Strasbourg in 20 07 (see
http://www.europarl.europa.eu/sides/).
45)
General Agreement on Tariffs and Trade.
12
established in the United Nations conference on trade and occupation, held in
Havana in March 1948, but was blocked by the U.S. Senate. Some historians have
assumed that failure may have resulted from fears coming from within the U.S.
business community, that the „World Trade Organization” could be used to
regulate, rather than liberate, big business.
World Trade Organization promotes economic globalization and free trade,
which are considered by many to be two topics of concern. World Trade Organization
treaties have been accused of bias tendency toward multinational corporations and
rich countries. While partnership is voluntary, critics believe that non-joining places
non-participant nation under embargo, creating an international system of constrained
economic rules and discouraging exchange and experimentation.
The decision-making process within the organization and in terms of
organization was also subject to criticism. The three major members – the United
States of America, the European Union and Japan have been accused of using
the World Trade Organization to exert undue influence over the less-powerful
Member States. In addition, some believe that Member States have adopted
treaties undemocratically or to the detriment of their citizens or the environment.
3.2. The European Patent Office (EPO), based in Munich, part of the European
Patent Organization, established by the European Patent Convention, is basically
aimed to issue the European patent for invention. Official working languages of the
European Patent Office are English, French and German. World Intellectual
Property Organization (WIPO) is an observer of the works of the European Patent
Office Board of Directors, according to an agreement signed by the two institutions.
A European patent is valid up to 20 years from the date of filing the application.
The European Patent Convention formally stipulates that „any infringement of a
European patent shall be dealt with by national law” in the area.
4. Counterfeiting of pharmaceuticals and medical devices. Practical
approaches. Competition and innovation activities in the pharmaceutical area are
global, and unfair competition practiced by pharmaceutical trusts that
unreasonably delay market entry of generic medicines has been the subject of an
„Antitrust Report on shortcomings in pharmaceutical sector”
46)
at EU level.
According to the report in the European community, there were spent about 214
billion euros in 2010, (about 2% of European GDP) for pharmaceutical products,
about 430 euros per EU citizen
47)
. It was also found that, unaccountably, during
the period 1995-2000 there was registered a decline of new drugs entering the
market from 40 to 27 new pharmaceuticals, which in conjunction with trusts’
46)
Presented in Brussels on July 8
th
, 2009 (see
http://europa.eu/rapid/pressReleasesAction.do?reference= IP/09/1 098&language=RO).
47)
See Antitrust Report on shortcomings in pharmaceutical sector in the European Union
(http://europa.eu/rapid/ pressReleases Action.do?reference= IP/0 9/1098&language=RO).
13
attempts to extend their market penetration, as generic drugs, has led to major
losses of public health systems of member countries and therefore on consumers.
A justification of the big drug manufacturers, for manoeuvres mentioned above,
is the loss of 45 billion euros due to counterfeiting of pharmaceuticals
48)
. According
to the World Health Organization., in 2010, the counterfeit medicines and medical
devices market ranged at approximately $ 75 billion, 90% more than in 2005, and
for 2011 experts in the specialty industry forecast an increase by 13%
49)
.
In Europe, counterfeit drugs market ranged at about 10.5 billion euros in
2010, the EU average of consumers of such pharmaceutical products amounting to
20% of the total community population
50)
. An impressive number if we consider
that, in France, nearly 7 million people made already use of counterfeit drugs, and
the German and British citizens have bought in 2009, counterfeit swine flu
antiviral drugs worth many million of euros, generating a profit of about 60,000
pounds per day to Russian criminal organizations
51)
. Over 2 million people in the
United Kingdom have consumed, in 2007, counterfeit „Prozac” and „Viagra”
purchased online from the Internet
52)
, which prompted the European Commission
to initiate relevant legislation in order to regulate virtual pharmacies’ status
53)
.
A check carried out by European authorities in December 2009 revealed that
62% of pharmaceuticals purchased online are counterfeit in whole or fall below the
standards required (the active substance does not meet requisite dosage)
54)
.
Champions of the consumption of counterfeit pharmaceutical products are Germans
48)
M. Botezatu, Chirac, Campaign against Counterfeit Drugs, article published in the daily
newspaper „Evenimentul zile i” of October 12
th
, 2009 (see http://www.evz.ro/detalii/stiri/chirac-
campanie-impotriva-medicamentelor-contrafacute-871412.html).
49)
See R. Collia-Suzuki, The War a gainst Counterfeit Drugs, „The Pharma Packaging and
Labeling USA 2 011” Conference, which took place on April 12
th
– 13
th
, 2011 in Washington DC,
Columbia, (see http://www.pharmaceutical-technology.com/features/feature114 721/).
50)
See A. Bardas, Cumperi medicamente contrafăcute? (Do you buy counterfeit drugs?),
article published on the site Ziare.com, on February 28
th
, 2011, (see
http://www.ziare.com/economie/stiri-economice/cumperi-medicamente-co ntrafacute-996235).
51)
See I. Ursu Pe internet se vând medicamente contrafăcute împotriva gripei porcine (Counterfeit
swine flu drugs sold on the Internet), article published on the site Ziare.com, on November 16
th
, 2009
(see http://www.ziare.com/stiri/gripa-porcina/pe-internet-se-vand-medicamente-contrafacute-impotriva-
gripei-porcine-951761).
52)
Nu consumaŃi medicamente de pe Internet, (Stop consuming drugs on the Internet), article
published on the site Ziare.com on January 11
th
, 2008 (see http://www.ziare.com/articole/medicamente-
contrafacute).
53)
See Opinion of the Economic and Social Committee on the Proposal for a Directive of the European
Parliament and of the Council amending Directive 2001/83/EC on the prevention of the entry into the legal
supply chain of medicinal products which are falsified in relation to their identity, history or source of 2009
(see http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0083:RO:HTML).
54)
See A. Serghescu, Pilulele de slăbit false sunt cel mai des cumpărate medicamente pe piaŃa
neagră (Counterfeit weight-loss pills are most often bought drugs on the black market), article published
on the site Ziare.com, on February 16
th
, 2010, (see http://www.ziare.com/articole/medicamente-
contrafacute).
14
38%, Italians 37% English 12% and Dutch 10%, the „favourite” products being
weight-loss drugs, „Tamiflu” influenza drug, „Viagra” and „Liptor”.
According to statistics of the World Customs Organization, counterfeiting of
pharmaceuticals brings to organized crime proceeds of approximately $ 200 billion
annually
55)
, trade in such products becoming more profitable than drug trafficking.
At this point we argue that trade in counterfeit pharmaceuticals turned into a global
issue, and for its solution it appears a fortiori the effective cooperation between
relevant industry and national and international authorities. A top of counterfeit
pharmaceuticals, provided by the World Customs Organisation, places in top five
weight-loss drugs, anti-infective, cardiovascular, for the central nervous system
protection and anticancer drugs. We may illustrate in this regard reports drafted by
„GlaxoSmithKline” and „Pfizer” which show that approximately 50% of drugs sold
online are counterfeit, being identified pills where the active substance was not
sufficient to produce health effects and in the contents there were identified
impurities, unauthorized substances and even other drugs
56)
.
In May cy, Hazim Gaber, Canadian citizen, pleaded guilty in Phoenix (USA)
for Internet sales of counterfeit medicines used to treat cancer. He sold common
white powders, such as starch, dextrin, dextrose or lactose, as „sodium
dichloroacetate”
57)
to 65 patients from North America and Europe. In another
case, thousands of patients in the UK have purchased counterfeit „Casodex”,
prostate cancer medicine.
In late 2008, the border police of several European countries managed to
capture 34 million counterfeit pills. In the context of „Medi-Fake” operation,
Belgian customs at the airport in Brussels made the biggest catch of illegal drugs
in Europe, namely 2.2 million tablets, of which 1.6 million analgesic drugs and
600,000 pills against malaria. Also, the French authorities made a stunning catch
in the town of Le Havre, 11 million pseudo-ephedrine tablets, an extremely
dangerous precursor used for drug production
58)
.
Relevant examples are thrilling if we keep in view that there are sold
counterfeit drugs and medical devices to treat cancer, AIDS and other diseases
and that 200,000 people die annually due to consumption of counterfeit
55)
See G. Miller, E. Duggan, Top Counterfeit Drugs Report, article published on the site
www.sproxil.com on August 16
th
, 2010 (see http://www.fiercepharmamanufacturing.com/node/
8843/Chart%20courtesy%20 of%20PSI).
56)
See http://www.fiercepharmamanufacturing.co m/signup?sourceform=Viral-rTynt-Fierce
PharmaManufacturing-FiercePharma Manufacturing.
57)
Medicine used to treat cancer that decreases p roliferation and inhibits tumour growth,
without apparent toxicity (see http://en.wikipedia.org/wiki/Dichloroace tic_acid).
58)
Captură de 34 de milioane de medicamente pe teritoriul U.E. în 2 luni (Capture of 34
million of drugs across the EU in two months), article published in daily newspaper „Romania
Libera” of December 1 6
th
, 2008 (see http://www.ro manialibera.ro/actualitate/eveniment/34-de-
milioane-de-medicamente-ilegale-capturate-pe-teritoriul-ue-141904 .html).
15
medicines
59)
. The U.S. has seen an increase by 800% in the number of cases of
counterfeit pharmaceutical products between 2000 and 2006. In the early 2009, a
U.S. federal police operation led to the seizure of counterfeit drugs worth 20
million dollars, being seized: antibiotics, anti-malarial drugs, contraceptives, anti-
tetanus vaccines, aspirin and medicines for erectile dysfunction treatment.
Unfortunately, not only drugs are target for counterfeiters. In 2009, 2 million
counterfeit insulin needles were found in Great Britain and on the Dutch market.
In the Netherlands, the discovery came after the manufacturer received a
complaint from a patient who acquired a set of needles that did not fit properly on
the insulin pen. A total of 200,000 counterfeit needles were found on the Dutch
market, 500,000 in Great Britain and needles worth over 1.3 million in Poland.
Right now, 30,000 counterfeit needles are still in circulation in the Netherlands
60)
.
French police discovered in 2008 in the town Messimy, near Lyon, the largest
clandestine laboratory to produce illegal drugs. The laboratory was identified after
several weeks of investigation undertaken by French police throughout the
country, it was located on the ground floor of a two-floor apartment building, and
counterfeit medicines were in the form of pills, suppositories or creams. After
their manufacture, pharmaceutical products were packed and sent by mail,
recipients being especially cancer patients. The total amount of drugs found at the
site was some cubic meters, investigators also discovering lists of recipients and
invoices allowing the location of patients and thus getting important evidence in
the investigation. Nine people were detained and dozens of searches were
conducted to determine „the whole channel” of distribution and manufacturing of
drugs, investigators adding that they shall continue their investigation in order to
„determine their responsibilities in the network activity, as well as the precise
extent of traffic”
61)
.
5. EU Strategy in the area of population protection against counterfeit
medicines and medical devices. Since the „counterfeit pharmaceuticals’ industry”
seriously affects public health, the EU adopted a strategy on population protection
against counterfeit medicines and medical devices, which envisages, inter alia
62)
:
better regulation of the pharmaceutical market;
products cheapened by the manufacturer, wholesaler and pharmacy;
tightening rules on the inspections in the pharmaceutical field;
59)
M. Botezatu, op. cit.
60)
R. Collia-Suzuki, op. cit.
61)
Vast laborator de medicamente contrafăcute, descoperit lângă Lyon (Large counterfeit drugs
laboratory, found near Lyon), article published on the site Ziare.com, on March 10
th
, 2008, (see
http://www.ziare.com/stiri/frauda/vast-laborator-de-medicamente-contrafacute-descoperit-langa-lyon-
324742).
62)
See http://www.mhra.gov.uk/Safetyinfor mation/Generalsafetyinformationandadvice/
Adviceandinformation forconsumers/Counterfeitmedicinesanddevices/inde x.htm.
16
introduction of a unique seal for pharmaceuticals and reseal lock-out;
the ability to identify batches of products throughout the entire production-
distribution channel;
increasing transparency by building a common database under which a
product can be identified;
tightening rules on the import, export and transit of drugs across the EU;
introduction of the notification procedure for manufacturers or importers
of active substances.
The European Security Strategy provides important measures in intellectual
property, considering, in the first place, promotion of innovation and creativity,
labour market development and improvement of competitiveness, but at the same
time protecting the EU interests in the area.
During the last decade, statistics recorded worrying extension of the
counterfeiting and piracy phenomenon, which actually turned into a super
profitable industry”, with direct links to cross-border organized crime, which
prompted the European Commission to propose, on September 25
th
, 2008 the
establishment of the European Observatory on Counterfeiting and Piracy
(hereinafter called the Observatory). The main objectives of the Observatory are:
Improving the quality of information related to counterfeiting and piracy;
The establishment of statistical database enabling rapid identification and
stopping imports of counterfeit and pirated products in the EU;
EU implementation of the best strategies to fight against the phenomenon,
and also use of the latest techniques for detecting counterfeits and their
popularization within the Union;
Implementation of a uniform strategy in preventing and fighting against
the phenomenon;
Interconnection of public and private system for an effective fight against
piracy and counterfeiting;
Awareness of European public opinion, in order to limit the harmful
effects of consumption of counterfeit goods.
Three working groups have been created within the Observatory, whose initial
topics are: surrounding data gathering, assessing the European and Member
States’ legal framework and European public awareness.
The Observatory is composed of members from both the public sector (the
existing structures of the European Commission) and the private sector (industry
representatives, European and national associations, etc.) and experts participating
in regular meetings focused on timely issues embodied in specific reports, which
reflect the real situation of piracy and counterfeiting in the EU. Also, the
Observatory will prepare a detailed annual report with the identified problems and
proposed measures in the production and marketing of counterfeit products.
17
2008 Council Resolution on a comprehensive European anti-counterfeiting
and anti-piracy plan
63)
provides in section 9 data of the Organization for
Economic Cooperation and Development report on the economic impact of
counterfeiting and piracy, particularly its estimate that international trade in
counterfeit and pirated goods may have been some USD 200 billion in 2005. Data
provided by the customs authorities of member countries of the Organization for
Economic Cooperation and Development indicate that „the total value of trade in
counterfeit or pirated products could exceed this amount by several hundred
billion dollars ...” in 2010
64)
.
Conclusions
Given those depicted above, we may argue that the protection of intellectual
property rights in the information society is an important element of economic
development of the internal market. Information Society opens new opportunities
under which protected works or products can be exploited via computer, Internet
and interactive services. Copyright, related rights and industrial property rights are
not just an ex post reward for the creators’ work, but also a means to encourage
them to create more. Holders must be eligible for protection of rights, regardless
of national borders or methods of use during the entire period of validity.
In the information society, piracy and trade in counterfeit products prevent the
continuation of creative activities that would be financially profitable. We should
bear in mind that information assets carry an atypical cost structure, in which most
expenses are in the design and production phase.
Economic justification of patent-protected new pharmaceutical products lies
not only in paying research teams for their work, but also in ensuring adequate
incentives for researchers to continue their creative work, with the view to provide
the population with tools to fight against serious disease and similar other
challenges to come.
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63)
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18
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