Advice Pool - Insurance

About 87 percent of the residents have statutory health insurance. As of May 2005, the statutory relied on 321 non-profit sickness funds to collect premiums from the

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

ir members and pay health care providers according to negotiated agreements. Those who are not insured this way, mainly civil servants and the self-employed, receive

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

Examples of combination products may in

health care through private insurance. An estimate of 0.3 percent of the German population (around 250,000 people) has no health insurance at all. Some of them are

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

o rich that they do not need it but most of them are poor and receive health care through social assistance.

Private Health Insurance

About eleven

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

percent of Germany's residents pay for private health insurance provided by some 40 for-profit insurance carriers. Many of those choosing private insurance are civi

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

Combination pro

servants who want to secure percentage of their medical bills not covered by the government. Some sickness-fund members buy additional private insurance to cover su

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

ch extras as a private room or a choice of physicians while in a hospital. Otherwise, the medical care provided to the publicly and privately insured is identical. I

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

both cases the same medical facilities are used. Self-employed persons earning above the income ceiling must have private insurance. Members of a sickness fund who

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

leave it for a private insurance carrier are not allowed to return to public insurance.

As opposed to the statutory heath insurance, contributions to the private in

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

urance depend on the member's age, gender, occupation and health status, that is, the individual risk. Although private insurance companies pay health care providers

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

about twice the amount paid by the primary sickness funds, private insurance is often cheaper than statutory health insurance, especially for younger policyholders

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

Following aspects would a

without dependents. As is the case for members of sickness funds, employees who have private insurance have half their premiums paid by their employers.

Sta

dd to the challenges in developing combination products:

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

utory Health Insurance

There are three different categories of sickness funds: primary funds, substitute funds and special funds. Some workers are required

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

to be members of the primary funds, e.g. if they earn less than the than the income ceiling (2006: EUR 3,937.50 per month / EUR 47,250.00 per year). Those earning m

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

re than that ceiling may be members on a voluntary basis, or they may have a choice of funds. Some of them automatically become members of a particular fund for exam

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

ple because of their occupation (company-based funds) or place of residence (local sickness funds). Some occupations have their own special funds, e.g. farmers or sa

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

Professional from academic institutions, pharmaceutical industries, health care indust

lors. Substitute funds are divided into two kinds: they provide health insurance to both white collar workers and blue collar workers earning more than the income ce

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

iling. Membership is voluntary.

Both, employers and employees pay half of a member's premiums, which in 2006 averaged between 13 and 14 percent of a worker’s gross

.

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

arnings up to the contribution assessment ceiling (2006: EUR 3,562.50 monthly / EUR 42,750.00 p.a.). Premiums are fixed according to earnings rather than risk and ar

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

Companies that provide selfless information through particip

e unaffected by the respective member's marital status, family size, or health. Premiums are the same for all members within a particular fund with the same earnings

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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Advice Pool - Health Insurance in Germany

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