Actual - Legal

2006 saw employers getting to grips with age discrimination and the new TUPE regime. Here, we look at what is in store for 2007.

Work and families

Last July we looked at the Work and Families Ac

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

t 2006 when the detailed Regulations were still in draft. We now have the final version of the Regulations. The key changes to the law are as follows.

The new rules will apply to employees whose babies

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

Examples of combination products may in

are due to be born or placed for adoption on or after 1 April 2007.

Extension of maternity leave period

Under the new Regulations all pregnant employees will be entitled to 52 weeks leave when th

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

ir babies are born.

Notice period for return from maternity leave

Employees who wish to return to work earlier than the end of their statutory maternity leave period will be required to give thei

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

employer 8 weeks notice.

Statutory Maternity Pay period

The statutory maternity pay period will increase to 39 weeks from April 2007 - 6 weeks at 90% of pay and 33 weeks at the flat rate (?108.8

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

Combination pro

). The Government has announced that it intends to increase the pay period to one year by the end of this Parliament (2009/10).

Keeping in touch days

The Regulations allow an employee on materni

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

y leave to agree with their employer to work for up to 10 days during their leave without bringing the leave to an end. This is to allow employees to attend training courses or business or skills updati

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

g without prejudicing their maternity leave.

Reasonable Contact

Under the Regulations, employers are entitled to make 'reasonable contact' with employees during maternity leave.

Flexible work

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

ng

The law at present provides that parents with 26 weeks' service who have children under six (or under 18 if the child has a disability) are entitled to apply to work flexibly. The Act extends thi

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

right to carers of adults from 6 April 2007. The minimum service requirement (26 weeks) will remain the same.

An employee will be entitled to make a request to work flexibly if he or she is caring for

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

r expects to care for an adult to whom they are married or who is their partner (living together) or civil partner or who is a 'near relative', or an adult who lives at the same address as they do. 'Near

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

Following aspects would a

relative' will mean the employee's parents, parents-in-law, adult child, adult adopted child, siblings (including in-laws), uncles, aunts, grandparents or step-relatives.

There is no current proposal to

dd to the challenges in developing combination products:

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

extend this right to parents of children aged between 6 and 17 who do not have a disability.

Smoke-free work places

Under new legislation, virtually all enclosed and substantially enclosed workpl

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

ces must be smoke-free from 1 July 2007 (there are a few very limited exemptions). This will include company cars and other work vehicles. Designated 'smoking rooms' will no longer be allowed.

Employer

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

will face fines if they allow employees to smoke at their workplace or if they fail to display adequate no-smoking signs. Failure to display a no-smoking sign will incur a fine of up to ?1000 or a fixed

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

enalty notice of ?200. Failing to prevent smoking in what should be a smoke-free place will incur a fine of up to ?2,500.

Information and consultation

From 1 April 2007 the Information and Consu

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

Professional from academic institutions, pharmaceutical industries, health care indust

tation of Employees Regulations 2004 will extend the requirement to make available a formal information and consultation procedure to all businesses employing at least 100 employees.

New rates of comp

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

nsation

Any employee who is unfairly dismissed on or after 1 February 2007 will be able to claim a maximum compensatory award of ?60,600. The rate of statutory redundancy pay will increase to ?310 p

.

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

r week (from the current level of ?290 per week). The new maximum amount of a statutory redundancy payment will be ?9,300.

New rates of statutory pay

From 1 April 2007, the standard rate of Stat

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

Companies that provide selfless information through particip

tory Maternity Pay, Statutory Paternity Pay and Statutory Adoption pay will be ?112.75 per week.

The weekly rate of Statutory Sick Pay will increase on 5 April 2007 to ?72.55 (the current rate is ?70.05)

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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