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

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