Protection of inventions in the pharmaceutical sector through supplementary protection certificate

Author:Viorel Ro?
Position:PhD, Faculty of Law, 'Nicolae Titulescu' University of Bucharest (e-mail: viorelros@asdpi.ro).
Pages:7-30
SUMMARY

The topic of health is nowadays, more than ever in the history of mankind, one that enjoys an entirely special attention. It concerns, albeit at a different level, the sick and the healthy, doctors and patients, the young and the elderly, women and men. It concerns governments and individuals, medicine and herbal medicine researchers, and beneficiaries of the research activity. The paper below is ... (see full summary)

 
FREE EXCERPT
LESIJ NO. XXII, VOL. 1/2015
PROTECTION OF INVENTIONS IN THE
PHARMACEUTICAL SECTOR THROUGH
SUPPLEMENTARY PROTECTION CERTIFICATE
Viorel ROŞ*
Abstract
The topic of health is nowadays, more than ever in the history of mankind, one that enjoys an
entirely special attention. It concerns, alb eit at a different level, the sick and the healthy, doctors and
patients, the young and the elderly, women and men. It concerns governments and individuals, medicine
and herbal medicine researchers, and beneficiaries of the research activity.
The paper below is aimed to present special issues regarding the patent for medicinal products
and authorisation of placement on the European market of medicinal products.
Keywords: health, medicinal products, research activities, su pplementary protection
certificate, costs, temporary monopoly, territorial monopoly, authorisation procedure.
1. Health care policies worldwide
and health care institutions in the EU*
Health is a component of the standard
of living that also comprises the health care,
enshrined as a universal human right under
art. 25 of the Universal Declaration of
Human Rights
1
, and in harmony with that
the World Health Organization has
stipulated i n its Constitution that its
objective is the attainment by all peoples of
the highest possible level of health.
The “Alma-Ata Declaration” adopted
in 1978 formulated the organization’s
disease fighting strategy. The Ottawa
Charter of 1986 formulated the
organization’s concept o n health and
maintaining it through the disease fighting
strategy. The organization is responsible for
managing certain health r isks on a
worldwide basis, establishing the health
research agenda, offers technical assistance
* PhD, Faculty of Law, ”Nicolae Titulescu” University of Bucharest (e-mail: viorelros@asdpi.ro).
1
Adopted at 10 December 1948 by the Resolution no. 217A, in the third session of the UN General Assembly.
to the Member States, monitors and assesses
the people’s health, and approaches the most
complex population health challenges.
Lately, some of t he WHO’s a ctions in
the health car e domain have been
controversial, the organization having even
been accused of bioterrorism in the form o f
the support given to certain manufacturers of
vaccines that are actually biological
weapons, and of affiliation to international
corporate crime syndicates. These
accusations must be regarded with
reservation, however they cast doubt on the
overall activity of this organization and on
the efficiency of its actions.
The topic of health, defined by the
World Health Organization as a state of
complete physical, mental and social well-
being and not merely the absence of disease
or infirmity”, or as a state that should
ensure a physical and mental state allowing
a person to become productive and useful
to society”, is nowadays, more than ever in
8 Lex ET Scientia International Journal
LESIJ NO. XXII, VOL. 1/2015
the history of mankind, one that enjoys an
entirely special attention. It concerns, albeit
at a different level, the sick and the healthy,
doctors and patients, the young and the
elderly, women and men. It concerns
governments and individuals, medicine and
herbal medicine researchers, and
beneficiaries of the research activity.
The international cooperation in the
health domain takes most complex forms.
Over the past years, a special attention has
been paid to the cooperation and promotion
of new medical technologi es and new
(original, innovating, or generic) efficient
medicines to be made available to the
population, including the poor countries’
people for whom the access to generic
medicines (much cheaper than the innovator
ones) is essential. In 2001, the “Declaration
on intellectual property and public
health” was adopted at the Conference in
Doha, which offers an answer to the
concerns expressed by the developing
countries about the need for a more facile
and less b urdensome access to a range of
essential medicines designed to fight major
epidemics, at the same time offering the
necessary assurances to the manufacturers of
pharmaceutical pr oducts on the observance
of the intellectual property rights, with a
view to e ncouraging the furthering and
development of the research activities.
The European Union has also
implemented concrete actions in the public
health domain, the health care concerns
targeting not only the diagnosis and
treatment, but also prevention. The basic
principle of the health care policies of the
European Union has become, „health in all
policies”, and the Lisbon Treaty has
emphasized the impor tance of the health
policy, stipulating that, a high level of
human health protection shall be ensured in
the definition and implementation of all
Union policies and activities”. In its turn, the
Charter of Fundame ntal Rights o f the
European Union proclaims, under art. 35
(Health care), that „Everyone has the right of
access to preventive health care and the
right to benefit from medical treatment
under the conditions established by national
law and practices. A high level of human
health protection shall be ensured in the
definition and implementation of all Union
policies and activities”.
From the historical viewpoint, the
Community health care policy originates
from the health and safet y provisions,
developed pursuant to the free circulation of
the persons and goods within the internal
market, which has made possible the
coordination of the health care activities and
actions. The consumption and dependence
on drugs, the expansion of serious diseases
like cancer, the new diseases like AIDS, the
crisis caused b y the b ovine spongiform
encephalopathy (BSE), all these represent
major health issues, which in conjunctio n
with the ever freer circulation of the patients
and medical personnel within the EU have
secured the public health an even more
important role on the EU’s agenda. Amid the
crisis caused by ESB, the Directorate
General or Health and Consumers of the
Commission (DG-SANCO) has assumed the
coordination of all the health related
domains, including the medicines, albeit the
main responsibility for the protection of
health, and in particular of the health
systems, further lies with the Member States.
The strengthenin g of the specialized
agencies like the Euro pean M edicine
Agency (EMA) and the establishment of the
European Centre for Disease Prevention
and Control (ECDC) evidence the
increased commitment of the EU to the
health policy.
The European health policy is aimed at:
(i) Offering all the Union citizens
access to high quality health care;
(ii) Preventing diseases;
(iii) Fostering a healthier life style, and

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