Thread by @AndrewChapman50

Back in December 2017, with the aid of a useful graphic, Michel Barnier explained that under a UK-EU FTA, the UK would have 'regulatory autonomy' - which is to say that we will not be bound to follow any EU rules and regulations.

ec.europa.eu/commission/sit…

He pointed out the UK's red lines: no ECJ jurisdiction, no free movement, no substantial ongoing financial contribution, independent trade policy, and regulatory autonomy, and observed that neither the EEA-EFTA, nor the Swiss, nor the Ukraine, nor the Turkey model were compatible

with them. They were however compatible with an FTA of the type of the CETA and EU-Korea FTAs.

Under these FTAs, Canada and Korea (that is, South Korea) do not generally bind themselves to adopt or conform to a EU laws and regulations.

Take CETA, for

example, and Ch. 4 'Technical Barriers to Trade', which applies to 'the preparation, adoption, and application of technical regulations, standards, and conformity assessment procedures that may affect trade in goods between the Parties.'

trade.ec.europa.eu/doclib/docs/20…

Its purpose clearly is to reduce technical barriers to trade (TBTs). Does this involve Canada aligning itself with EU regulations? Let's take a look.

The next paragraph of Article 4 incorporates several provisions of the WTO TBT Agreement, including:

Article 4.3 provides that the Parties should strengthen their cooperation in the areas of technical regulations, standards and so on, as set out in Ch. 21 'Regulatory Cooperation':

The only reference to EU law in Ch. 21 is in connection with the reciprocal exchange of information concerning product safety. It is immediately followed by a reference to similar Canadian law, and neither Party is required to adopt the law of the other:

Returning to the TBT chapter, Art 4.4 facilitates the harmonisation of the Parties' technical regulations. First, if Party A wants to make a regulation equivalent to a regulation of Party B, then Party B is to assist Party A in doing so, to the extent possible:

Second, Art 4.4.2 provides for one Party to recognise a regulation of the other as equivalent to its own. Recognition cannot be refused without reasons being given:

These provisions build upon the requirement in the WTO TBT Agreement for Members to give positive consideration to accepting regulations of other Members as equivalent to their own:

wto.org/english/docs_e…

CETA 4.5 provides that the Parties shall observe two Protocols, one on the mutual acceptance of conformity assessment results, and one on the mutual recognition of the Parties' pharmaceutical GMP programmes:

The conformity assessment Protocol (data.consilium.europa.eu/doc/document/S…) contains procedures to allow the EU to recognise Canadian certifiers as competent to certify products as compliant with EU regulations, and vice versa. It contains references to one Article of one EU legal act, namely

Decision 768/2008, and Article R17 'Requirements relating to notified bodies', which begins:

Under the Protocol, a conformity assessment body (CAB) designated by Canada to certify products for the EU market must meet these requirements:

All this is saying is that Canadian certifiers for the EU market must meet the same requirements as EU certifiers.

In the same way, EU certifiers for the Canadian market must the same requirements as Canadian certifiers:

It's just that in Canada, all that is required is accreditation by a recognised accreditation body, without reference to a law.

And in fact, the Protocol provides for the EU accepting accreditation as sufficient where the accreditation requirements are equivalent to those of

Article R17.

The matter is hardly more than extension of the principle that any exporter complies with the product regulations of the countries it is exporting to. If conformity to these regulations is to be assessed by locally established certifiers, then it is hardly

surprising if these, for this purpose only, have to comply with the importing countries's regulations and procedures for certifiers.

(to be continued)

Under CETA, there is no recourse to the ECJ, even if a dispute raises a question of the interpretation of EU law. If an arbitration panel is set up, it is to the follow the 'customary rules of interpretation of public international law', including those of the Vienna Convention:

It should also take into account relevant interpretations in WTO disputes.

It is conceivable that the arbitration panel could have to decide on the interpretation of a clause in Art R17 of Decision 768/2008. It is sometimes said that the EU does not allow its law to be

interpreted by any body other than the ECJ, but does this not constitute an exception? @Lorand_Bartels @hhesterm (EU law in CETA (in Conformity Assessment Protocol) to be interpreted by arbitration panel).

@Lorand_Bartels @hhesterm The above seems to be correct:

https://twitter.com/Lorand_Bartels/status/1197128436919218177

It is unacceptable for a similar provision, if there is one, in a future UK-EU FTA, to be subject to rulings on interpretation by the ECJ. This CETA example shows there is no necessity for ECJ referral in such a case.

@Lorand_Bartels @hhesterm Returning to CETA 4.5 'Conformity Assessment', the 2nd protocol to be observed by the Parties is that for GMP mutual recognition.

As a preliminary observation, GMP guidelines have been harmonised internationally to a great degree through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

A German govt study found that the EU's GMP guidelines were closely aligned to the WHO guidelines, through ICH and PIC/S guidelines: frl.publisso.de/resource/frl:5…

The EU-Canada GMP Protocol (data.consilium.europa.eu/doc/document/S…) replaces an existing EU-Canada GMP MRA (academy.gmp-compliance.org/guidemgr/files…).

Each Party accepts certificates of GMP compliance that have been issued by 'equivalent' regulatory authorities of the other:

Each Party operates under its own law, for example with respect to the definition of what is a medicinal product (EU) or drug (Canada):

(to be continued)

CETA 4.6 'Transparency' is based closely upon the Parties' existing WTO obligations to notify other WTO Members of proposed new technical regulations in time amendments to be made in response to comments received. Thus, WTO TBT 2.9.2 requires notifications at an early stage:

while CETA 4.6.3 specifies that at least 60 days should normally be provided for comments by the other Party under the WTO notification system:

Again, while TBT 2.9.4 requires Members to 'discuss' and 'take into account' written comments received:

CETA goes somewhat further by requiring replies 'in writing':

Each Party thus retains its regulatory autonomy, but under the constraint imposed by their WTO obligation (TBT 2.2) that new technical regulations should not be more trade-restrictive than is necessary to fulfil a legitimate objective:

The notion that technical barriers to trade are to be lessened by one Party adopting the technical regulations of the other as their domestic regulations is absent from CETA's TBT chapter.