Harmonisation – add in notes from tut.

Concerned with eliminating disparities between the regulations and laws of states, through
the introduction of a common rule which applies to all states.

The EU is an important engine of harmonisation - it is unusual as a transnational body

because it has a very elaborate institutional structure, and an ongoing capacity to legislate. It
can pass law which harmonises the laws of the MSs. Language of negative and positive
integration often used...harmonisation described as a form of positive integration. MSs must
do X. One of the things that is striking about the EU as a transnational org is that it seeks to
strike a balance between negative & positive integration.

Minimum v exhaustive harmonisation

Minimum
Case C-289/96 Aher-Waggon
EU adopted a measure harmonising rules on noise from aeroplanes. Germany v
concerned about noise pollution in its cities, and introduced a national law setting a higher
standard for aeroplane noise in its cities. Can Germany do this?

 ECJ interpreted the EU directive as doing nothing more than setting down minimum
standards, to which MSs had to comply, but could go above, and introduce stricter
standards.

Exhaustive
Regulation 1907/2006 (REACH chemicals regulation)
Concerned with regulating the quality of chemicals in our environment, incl those in
consumer goods.
Article 128(1) – not open to MS to insist on stricter standards, because the reg is in the form
of an exhaustive harmonisation measure.
Exhaustive doesn’t just set the floor, but also sets the ceiling.

Possible to have mixed harmonisation

Case C-11/92 Gallaher
Involved an EU directive harmonising health warnings on cigarette packets. Have to cover
a certain percentage of the packet. SOMEONE wanted to insist that a greater surface area
of the packet should be covered by the warnings. Is it a minimum or exhaustive
harmonising measure?

 UK can insist that cigarette manufacturers within its territory impose bigger health
warnings. But, the UK cannot insist that those stricter standards are met by cigarettes
which are manufactured in another member state, Minimum for UK inside its
territory, but for manufacturers in other members states, it is an exhaustive
harmonisation measure, so the UK must grant market access so long as those
cigarettes meet the minimum standards laid down in the directive.
 Sometimes referred to as minimum harmonisation with ‘passport’ clause.
Case C-1/96 Compassion in World Farming
EU harmonisation measure which regulated the farming of veal calves. Said the crates that
you raise the calves in have to be of a certain size. UK said that this size wasn’t big
enough. Said they were going to insist on crates twice that size. Stricter standards than reg.
Protests broke out when UK farmers started to export calves to France. UK govt caved
and said they would ban the export of live calves from the UK when those calves are going to
be raised in conditions which don’t meet the stricter UK standards.

 ECJ said it was ok for the UK to regulate stricter standards within their territory, but
cannot impede exports on the basis that another state does not enforce those standards.

Details/Framework
Framework rules accompanied by procedural requirements.

Is harmonisation a good way of achieving market integration in a context of global legal

pluralism? Depends in part upon what kind of harmonisation.

Advantages

 Eliminating regulatory disparities which might otherwise disrupt trade. Exhaustive

better at that than minimum.
 Equalises competition across states. Different regulations impose a burden on
manufacturers.
 It’s hard to hold onto your own higher standards in a mutual regulation approach,
where you have to let in goods which are lower in standard of reg than your own.
Pressure to deregulate – can’t compete with cheaper goods. Harmonisation imposes a
single standard
Disadvantages
How do you ensure the legitimacy of rules adopted at a global level?
Govts accountable to their Parliaments back home. But in intl relations, Pmts tend not to
play a v significant role – sidelined in favour of executive bodies.

Question of the adequacy of the standards...

Often, when you get a load of countries together, by the time they agree on the standards,
they are very low. Tension between legitimacy & adequacy. Consensus degree of
legitimacy. Basis of informed consent. But then v likely that you have to ratchet the standards
down.

Is it really conceivable in our diverse world to think that there will be circumstances in which
‘one size fits all’?

Regulatory problems today are complex & nobody really knows what the right approach is.
Not just about political will. If you accept that, many argue that it is a v good thing to let
different countries try different approaches, but then to create structures which facilitate
regulatory learning across those states.
The WTO & Harmonisation
The WTO is, in the main, all about negative integration. Don’t do X. This is because the EU
does not have the same elaborate institutional structure as the EU. But one area of WTO law
which stands out as an exception – TRIPS.
TRIPS
The Rule: Article 27 – requires that member states make patents available for inventions.
Article 33 - Must run for a min period of at least 20 years.

Includes pharmaceutical drugs. Developed countries allowed to delay implementing this

until 2005, and the least developed allowed to delay until 2016.

Exceptions: Article 31 – about the ability of states to allow the use of patented inventions
without the consent of the patent holder. Compulsory licensing is allowed, where it complies
with certain conditions.
WTO came to revise the rules...AIDS sufferers in poorer countries could not afford drugs
produced under compulsory licence. Generic medicines. *Read attached WTO decision*
EU & US have found effective ways to undermine the waver:
If rules no longer working in their interest, will walk away from the WTO and insist that
poorer countries sign away their right to rely on the waver, bilaterally. TRIPS plus
provisions.
If WTO not achieving an adequate standard of protection, EU pushing for an new
substantive patent treaty which better protects interests.
Put those together, less surprising that poor countries don’t reap the benefits of the waver.