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Advice You - Property Rights and the EU
The European Community (also referred to as the European Economic Community) has as its task the establishment of a common market and the progressive approximation of the e
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
conomic policies of Member States. The term common market has been defined as an area, which consists of two or more Member States that abolish tariffs and other trade barr
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
iers in their mutual trade, set-up a Common External Tariff with third non-EU countries and apply the principle of the free movement of the sources of production (goods, la
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
or, capitals) within the territory of that area.
One of the fundamental principles of the European Union is the free movement of goods between Member States. Thus, Member
One of the fundamental principles of the European Union is the free movement of goods between Member States. Thus, Member
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
States are prohibited from imposing any restriction on imports or exports might hinder the free movement unless EC Law allows it. The European Union's Institutions through
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
their instruments and law regulations strive to develop a free commercial network that does not suffer from custom duties, quantitative restrictions, or other charges havin
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
equivalent effect on imports or exports.
While Member States impose these kinds of restrictions in order to protect their own interests, the Court of Justice, through its
While Member States impose these kinds of restrictions in order to protect their own interests, the Court of Justice, through its
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
decisions, acts to ensure that EC Laws are applied. Free movement of goods means in practice that no regulations or restrictions take place on Member States' borders as Ar
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ticles 25, 28 & 29 (ex Articles 12, 30 & 34) prohibit them. Specifically, while European Union Members try to impose restrictions of non-pecuniary or pecuniary nature on bo
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ders, the Court of Justice acts a "guard" by examining the legal basis and the purpose of the charge imposed.
Such restrictions or prohibitions shall not, however, constit
Such restrictions or prohibitions shall not, however, constit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ute a means of arbitrary discrimination or a disguised restriction on trade between Member States. A Member State may have resource to Article 30 (ex Article 36) of the Tre
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
aty providing for the said exceptions to justify a measure having equivalent effect to quantitative restriction on imports or exports only if no other measure, less restric
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ive from the point of view of the free movement of goods, is capable of achieving the same objective.
Although the Treaty does not provide any exceptions, the Court has he
Although the Treaty does not provide any exceptions, the Court has he
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ld in the past, that charges levied for tasks required by EC Law or charges for services rendered, do not breach Article 25 (ex Article 12). Regarding Articles 28 & 29 (ex
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Articles 30 & 36), the Court has introduced an exception called the Rule of Reason. It permits that restrictions can be imposed on goods as long as the Court of Justice all
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ws them.
Concluding, the burden of proof that a measure is justified lies on the Member State's concern and on the Court of Justice's decision. In the case of industrial a
Concluding, the burden of proof that a measure is justified lies on the Member State's concern and on the Court of Justice's decision. In the case of industrial a
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
nd commercial property rights litigation between private parties, the burden lies on the party seeking to oppose the importation or sale of the product concerned. Save meas
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ures relating to the protection of public policy or public morality, the adoption of other measures banning circulation of products and being able to jeopardize the free mo
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ement of goods lawfully marketed in another Member State, obliges the Member States concerned to exchange information with the Commission so that the latter to be enabled t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
o manage such measures affecting the free movement of goods and settle satisfactorily for business and consumers any problems arising in connection with the internal market
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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