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Recently, the EU members rejected the proposal of the European Commission to impose a formal system that would regulate any importer of leather shoes like Vie

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

tnam and China. The scheme was designed in order to replace emergency policies that were implemented last April. It must be noted that the temporary regulatin

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

g system was applied by the EU due to allegations that imported shoes were being sold at lower prices in order to gain a bigger share in the European markets.

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

At that time, the Commission stated that it was able to gather sufficient evidence that both China and Vietnam were subsidizing local shoe businesses in orde

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

r to gain an unfair advantage in the EU markets. According to EU Trade Commissioner Peter Mandelson, the implementation of a formal regulating system was need

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ed in order to protect all European manufacturers from any importer of cheaper goods such as shoe products.

The proposal was supported by shoe producers in m

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

ember states like Italy, Poland, and Portugal. According to them, European shoe manufacturers had to deal with higher production costs unlike their East Asian

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

competitors and thus could not compete with them in terms of pricing. However, the scheme was opposed by many retailers who argued that the system would force

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

them to increase their prices, a situation that might result to the decrease of their revenues. The temporary policy imposed on any importer in the EU market

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

s is due to expire in October.

The Commission, then, proposed a more formal system in order to regulate any importer from China or Vietnam. The policy needs

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

at least 13 votes from the 25 members of the European Union. But getting such level of approval even proves to be hard. The Commission initially suggested the

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

introduction of a quota system, which would allow 95 million pairs of imported shoes from Vietnam and 140 million from China.

Any importer that would exceed

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

the quota would have to pay up to 29.5% of duties. However, the idea was opposed by the majority of the EU members. The opposition was headed by major shoe m

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

anufacturers such as Italy, Poland, and Portugal. Moreover, the proposed policy was questioned as regard its legality under the global trade standards.

After

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

the proposal was rejected, the Commission came up with another scheme wherein 16.5% tariffs would be imposed on Chinese goods while 10% would be applied on Vi

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

etnamese products. However, that suggestion was also opposed by the EU members. Both Germany and Britain saw the duties as too harsh for any importer. A spoke

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

sman of Mr. Mandelson stated that the Commission would look for other alternative policies that would effectively protect European shoe businesses without bei

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ng too harsh on any importer. Meanwhile, retailers welcomed the decision of the Commission. Particularly, Horst Widmann, the head of the Federation of Europea

.

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

n Sporting Goods Industries, said that EU members have realized that imposing anti-dumping duties on both Vietnam and China would not help any European busine

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ss. Instead, it would only put at stake the interest of consumers and the competitiveness of EU markets, but also the credibility of international trade rules

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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