Tradoc - 153010.4.7 Pharmaceuticals

Pharmaceuticals in
TTIP
global supply chains. They produce a

medicine in stages, with different
ingredients coming from suppliers in
different countries.
2.
Enabling regulators to work

together more closely to ensure
medicines are safe and effective
In this chapter, we want to:

join forces to ensure medicines
meet strict standards of
efficacy, quality and safety
support each other's work on
developing regulations in new
areas.
Approvals
This is about the time and resources a

pharmaceutical company needs to devote
to get a new medicine onto the market.
When a company develops a new medicine,
it first has to carry out studies, including
clinical trials, before regulators will
consider whether it can sell its product.
These studies have to show that the
benefits of using the medicine outweigh
the risks.
We want to avoid the need for a company
to carry out the same studies twice in order
for both EU and US regulators to approve
its product.
3.
Reasons for negotiating

pharmaceuticals
We already work together with the US on
pharmaceuticals - for example, we have
removed customs tariffs on exports
between the EU and the US. And our
regulators work together closely.
With TTIP, we now want to help them work
together even more. Doing so would make
a difference for patients and industry
across Europe.
More specifically, we want to help
regulators in 3 main areas inspections,
approvals, and innovation
1.
Inspections
Regulators check the way companies make

medicines regularly, to ensure they meet
strict EU standards.
Doing this is more of a challenge
nowadays, because companies often use
Innovation
This is about helping regulators work

together closely in areas where science is
evolving fast.
Developing new medicines means working
at the cutting edge of science. This can
make it more of a challenge for regulators
to check if those products are safe.
We can make regulators' task easier, by
enabling them to:
share their expertise and findings

with each other
exchange views based on the latest

science available.
from the EU, the US and other

regions
EU goals
1.
Inspections
We would recognise each other's

inspections of manufacturing plants, based
on principles and guidelines known as
'Good Manufacturing Practice (GMP)'.
For so-called 'biosimilars':
These ensure companies produce their

medicines consistently, and to the required
quality standards. They cover things like:
manufacturing procedures and

equipment checks
laboratory analyses and recordkeeping
staff qualifications
systems for assuring products'

quality.
benefit from each other's

inspections, and the resources
needed to carry them out
avoid unnecessarily doing the

same work twice.
2.
Biological medicines are used to

treat a wide range of conditions,
such as cancer or auto-immune
disorders.
Here's a summary of the main ones, and

the EU's position on each.
Sensitivity/concern
EU response
1. Pricing medicines, reimbursing bills
Some people fear
Neither TTIP nor
EU governments
any other EU trade
would lose their
deal would affect
right to decide:
EU governments'
right to decide how
much people have
the prices
to pay or how
people pay for
they're reimbursed.
medicines, or
For all medicines, we want to help EU and

US regulators:
Regulators would work more

closely together on EU and US
requirements for medicines similar
to biological medicines which
regulators have already authorised.
Some issues in this chapter are sensitive or

have raised particular public concerns.
Approvals and innovation
Sensitive or controversial issues
By doing so, we would:
work more closely with each other

in areas where the ICH hasn't yet
agreed international rules for
example, on generic medicines.
exchange information that makes it

easier to decide whether to
approve medicines
The only thing EU

law requires of
governments is to
make their
decisions in a clear,
open way.
2. Transparency of clinical trial data
Some people are
The EU adopted a
concerned TTIP
new regulation on
might undermine
clinical trials in
work more closely with the US in

the International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use, or
'ICH' for short; this is an
international body that brings
together industry and regulators
2
how people are

reimbursed.
EU policies to
ensure the public
can see data from
trials of new
medicines.
2014 (number
536/2014). in
October 2014, the
European Medicines
Agency published
its final policy on
public access of
clinical data.
national health
systems, which
are already
stretched.
We wont negotiate
- either in TTIP or in
other EU trade
deals - any rules
that affect this
right in any way.
3. Protecting intellectual property
Some people worry The EU and US
TTIP would make it already have
harder for people to effective rules in
afford the
place for protecting
medicines they
intellectual
need, by handing
property.
companies even
stronger rights over These rules strike a
their intellectual
delicate balance by
property that stop
allowing:
other firms
producing the same companies to
medicine.
profit from their
research and
remain
amongst the
most
competitive in
the world
patients to
benefit from
new medicines.
We wont negotiate
anything in TTIP
which would:
upset this
delicate
balance, or
increase costs
for EU
countries'
3

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Pharmaceuticals in

global supply chains. They produce a

Enabling regulators to work

In this chapter, we want to:

This is about the time and resources a

Reasons for negotiating

Regulators check the way companies make

This is about helping regulators work

share their expertise and findings

exchange views based on the latest

from the EU, the US and other

We would recognise each other's

For so-called 'biosimilars':

These ensure companies produce their

manufacturing procedures and

laboratory analyses and recordkeeping

systems for assuring products'

benefit from each other's

avoid unnecessarily doing the

Biological medicines are used to

Here's a summary of the main ones, and

For all medicines, we want to help EU and

Regulators would work more

Some issues in this chapter are sensitive or

Approvals and innovation

Sensitive or controversial issues

By doing so, we would:

work more closely with each other

exchange information that makes it

The only thing EU

work more closely with the US in

how people are

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