Answers - Legal

What is a Will?

A will is a legal document that can protect your assets and help minimize any disagreement or dispute over the distribution of your estate when you die. A will is created and used to c

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

ontrol the distribution of property upon your death, to provide guidance or suggestion to the courts as to who should act as the guardian of your minor children after death, and to name the person who will manage your

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

Examples of combination products may in

state after you die. A will provides instruction for the distribution of your assets through the probate courts.

Why do I need a Will?

After you die, your assets are distributed to your heirs and ben

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

ficiaries (those named in the will) through an order of the probate court. The executor of your will (the person you name in your will) will gather up the assets and provide an inventory or list of the same to the prob

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

ate court. The executor will then oversee the testator's assets and to carry out the specific requests of the testator after he dies. The executor collects and manages the assets of the deceased, collects any debts tha

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

Combination pro

are owed to the testator at the time of his death, pays debts owed by testator (unless the will directs otherwise), sells estate property necessary to pay estate taxes or expenses, and files all necessary court and ta

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

documents for the estate.

What happens if I do not have a Will?

When a person dies without a will (commonly referred to as dying "intestate"), the probate court appoints a person to receive all of t

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

he claims made against the estate. The appointed person also pays creditors and then distributes all remaining property in accordance with the laws of the state. The major difference between dying with a will and witho

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

t a will is that intestate estate distribution is done in accordance with pre-set state laws (i.e. the state decides who gets what and in what proportions) whereas a person with a will can distribute his or her propert

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

in accordance with the instructions provided by the will.

What makes a valid Will? To make a valid will:

- the person making the will (known as the testator) must be at least 18 years of age and be

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

f "sound mind" - this means that the person must be able to understand the full meaning of the document.

- it must be written (except for a few uncommon circumstances).

- the testator must (in the vast majority of ca

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

Following aspects would a

ses) sign the document in the presence of two witnesses, and the signature must be witnessed and notarized.

Is a Will like a Trust?

Not really. A Trust is a legal document that details how property i

dd to the challenges in developing combination products:

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

owned, held or transferred before the death of the person making the Trust. Since the Trust is the legal owner of the transferred property and the Trust survives the death of the testator, this transferred property do

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

s not have to go through "probate" once the person making the Trust dies (i.e. it's no longer the property of the person making the Trust).

Can I change my Will?

Yes, at any time while you are still

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

alive. A will can be changed through a separate document to amend a will, called a "Codicil". Codicils are intended to deal with relatively minor changes to a will, not wholesale revisions. Since a Codicil must be sign

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

d and witnessed in the same way as a will, it is often preferable to have an entirely new will prepared than it is to prepare a Codicil to an existing will. To revoke a will, all that needs to be done is to execute a n

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

Professional from academic institutions, pharmaceutical industries, health care indust

w will that states that all prior wills are revoked. Also, a will can be revoked without making a new one by simply by destroying it - tearing it up, burning it, defacing the will, etc. To do so, however, would leave n

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

o will in place.

Is a Will public record?

Yes and no. While the testator is alive the will is not part of any public record. When the testator dies, the will must be filed with the probate court - an

.

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

it becomes a public record. However, very few people will view the will after it is filed with the probate court.

Learn more about creating Last Will and

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

Companies that provide selfless information through particip

Testament documents at Standard Legal

For more articles and information, visit the Standard Legal Law Library

# #

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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