MHRA acted lawfully in inspection of pharmaceutical company, rules High Court

In a judgment handed down today (R(Roche Registration Limited) v Secretary of State for Health acting by the Medicines & Healthcare Products Regulatory Agency [2014] EWHC 2256 (Admin)) Carr J found that that the MHRA acted lawfully in an inspection of Roche carried out in autumn 2013.

The inspection followed an earlier inspection of Roche in which the MHRA had made serious findings of alleged non-compliance with Roche’s pharmacovigilance obligations (obligations on pharmaceutical companies to monitor, and to report to the regulators on, potential problems with licensed medicines).

Following those findings, the European Medicines Agency (“EMA”) had started an investigation of Roche under the Penalties Regulation, which provides for the imposition of fines for breach of (among other things) pharmacovigilance obligations.

Roche complained that: (1) the EMA had had no power to issue a letter under Article 8(3) of the Penalties Regulation to the MHRA requesting provision of the report of the re-inspection to it for use in relation to the penalties proceedings; (2) that the MHRA had acted unfairly in not adequately disclosing the purpose of the re-inspection; and (3) that the MHRA had wrongly reported to the EMA that Roche was liable for the default of other Roche group companies and had wrongly assessed its compliance by reference to new obligations in force only after 2012.

The Judge dismissed the application on all points.  She held that on the facts Roche was not misled as to the purpose of the investigation or as to the possible use of the report in relation to the EMA’s investigation under the Penalties Regulation.  As for the EMA’s letter to the MHRA, although it was not clear that the EMA had power to make that request, the point was immaterial as the report would in any event have been provided to the EMA under other relevant provisions: so it was not appropriate to make a reference to the Court of Justice of the EU.  As to the MHRA’s alleged errors in its report, Roche’s real concern was not with the report but with the possibility that the EMA and the Commission (which takes the final decision on penalties) might accept those views in the context of the Penalties Regulation: and (applying Masterfoods) it was not right for the national court to pre-empt any decision by the Commission along those lines either by deciding the matter itself or by making a reference to the Court of Justice.  Such a decision could be challenged in the General Court, and that was the appropriate course for Roche to take.

George Peretz represented the MHRA.  Please click to download the judgment in Roche Limited v MHRA

DWF v The Secretary of State for Business Innovation

In a short judgment this morning in DWF v BIS  the Court of Appeal upheld a contract suspension under Regulation 47G of the Public Contracts Regulations (or rather did so in part), and gave some encouragement to those who look to pursue remedies other than damages in these claims.  The Court also gave helpful guidance as to when Claimants in procurement claims can amend their case to add to their complaints even when 30 days has expired since they learned of the relevant new facts.

 

Michael Bowsher QC appeared for the successful appellant, DWF LLP.  A case note will follow.

 

Please click to download the judgment in DWF v The Secretary of State for Business Innovation

This case has been featured in The Lawyer, which can be viewed here.

Brendan McGurk Featured in the Tax Journal

Brendan McGurk of Monckton Chambers has had an article published in the latest edition of the Tax Journal.

The article is an analysis of the Upper Tribunal judgment in Patersons of Greenoakhill Ltd v HMRC.

The Upper Tribunal dismissed the appeal for the landfill site operator (LSO) for the repayment of landfill tax paid on the disposal of biodegradable material (biomass), or that proportion of it, from which landfill gas is naturally produced. The decision illustrates that LSOs seeking repayment of landfill tax will have to demonstrate that they did not have an intention to discard material which is the subject of repayment claims. The ruling gives some indication as to the circumstances in which repayment claims by LSOs deriving electricity from methane produced by landfill might yet run.

For more information on Patersons of Greenoakhill Ltd v HMRC, please click here.

Judgment in Georgia v. Russia

The Grand Chamber of the European Court of Human Rights has today handed down judgment in the first inter-State case brought  using the special procedure of Article 33 of the Convention (i.e., one brought by one Member State of the Council of Europe against another) since the Court became a full time institution in 1998 and only the fourth such case ever to be brought before the Court.  The case of Georgia v. Russia (I), application no. 13255/07 concerned the alleged existence of an administrative practice involving the arrest, detention and collective expulsion of Georgian nationals from the Russian Federation in the autumn of 2006.

In its judgment in the case, which is final, the Court held, by a majority, that there had been:

a violation of Article 4 of Protocol No. 4 (prohibition of collective expulsion of aliens) of the European Convention on Human Rights;
a violation of Article 5 & 1 (right to liberty and security);
a violation of Article 5 & 4 (right to judicial review of detention);
a violation of Article 3 (prohibition of inhuman or degrading treatment);
violations of Article 13 (right to an effective remedy) in conjunction with Article 5 & 1 and with Article 3; and
a violation of Article 38 (obligation to furnish all necessary facilities for the effective conduct of an investigation).

The Court found no violation of Article 8 (right to respect for private and family life), no violation of Article 1 of Protocol No. 7 (procedural safeguards relating to expulsion of aliens) and no violation of Articles 1 and 2 of Protocol No. 1 (protection of property and right to education).

However, having regard to the parties’ submissions, the statements by 21 witnesses it had examined during a hearing in Strasbourg, and the reports from various international organisations, the Court found that in the autumn of 2006, a coordinated policy of arresting, detaining and expelling Georgian nationals had been followed by the Russian authorities, which had amounted to an administrative practice incompatible with the Convention.

 

The application to the Court was prepared by Piers Gardner and Jeremy McBride on behalf of the Ministry of Justice of Georgia.

 

To read the judgment in full, please click here.

Ian Rogers QC appointed member of the RFU Judiciary

Ian Rogers QC has been appointed a member of the Rugby Football Union (“RFU”) Judiciary.

Ian will sit on the panel to hear appeals, competition appeals and other specialised cases from time to time.

Ian recently acted in Park Promotions Ltd t/a Pontypool Rugby Football Club v Welsh Rugby Union, concerning contractual rights and the scope of the Bradley duty of fairness imposed on sports governing bodies by reason of their control over the sport.

Please click here for more information on this case.

Tim Ward QC of Monckton Chambers was also appointed to the RFU panel last year.

Upper Tribunal roundly rejects HMRC’s unlawful treatment of Tourist Boards

In a decision released today, the Upper Tribunal has held that HMRC’s approach to the taxation of bodies established by statute for the purposes of promoting tourism is incorrect. The ruling is good news for all Tourist Boards, particularly those that have been established by statute to serve the Governments in the country they have been established to promote, because it is now clear that there is no objection in principle to such Boards receiving regular VAT credits from HMRC.

Click here for an analysis of the case by Frank Mitchell, South African Tourist Board v HMRC case note.

Click here for a link to the Upper Tribunal’s decision, South African Tourist Board v HMRC judgment

Melanie Hall QC and Frank Mitchell acted for The South African Tourist Board

The comments made in this case note are wholly personal and do not reflect the views of any other
members of Monckton Chambers, its tenants or clients.

High Court upholds Home Secretary’s policy on recourse to public funds

The High Court has rejected a challenge to the Home Secretary’s “no recourse to public funds” policy. Under the Home Secretary’s policy, a foreign national granted permission to stay in the UK on the basis that she has a family life here cannot claim welfare benefits unless she is destitute or there are compelling reasons relating to the welfare of a child.

In a judgment handed down on 20 June, Mr Justice Kenneth Parker rejected a claim that the policy was incompatible with the Home Secretary’s statutory duty to have regard to the welfare of children in the UK. In a decision that illustrates the margin of discretion afforded to Ministers in matters of public policy, the Judge concluded that the policy accorded due weight to the welfare of children and that, in those circumstances, the Court could not strike down a public policy choice made by the elected government even if it disagreed with it.

Ben Lask acted for the Home Secretary.

Please click here to download the NS v Secretary of State Home Office Judgment.

Victory for sports bra retailers

The CMA today closed its investigation into the retail pricing of sports bras, concluding that there were no grounds for enforcement action against the parties involved.

In September last year, following a two year investigation, the OFT issued a Statement of Objections alleging that DBA, manufacturer of the “Shock Absorber” range, had entered into a series of resale price maintenance arrangements with each of Debenhams, House of Fraser and John Lewis, covering three separate periods between 2008 and 2011. This was the first time the OFT had proceeded with an investigation on its own initiative, without a prior complaint or leniency application providing detailed evidence regarding the specific conduct in question.

Once an SO is issued, it is unusual for the investigation to be closed: over the past five years, 90% of parties receiving an SO alleging an anti-competitive agreement or concerted practice have gone on to be the subject of infringement decisions.

However, in this case, following written and oral representations from the parties, the CMA reassessed the evidence on its file and concluded that there were no grounds for action against the parties.

Daniel Beard QC and Alison Berridge represented House of Fraser.

Anneli Howard and Michael Armitage advised the CMA.

Court of Appeal upholds the right to charge VAT on hot takeaway food

The Court of Appeal today confirmed that HMRC are entitled to charge VAT on hot takeaway food. Over 1,200 hot takeaway food outlets stood behind this test case brought by Sub One, part of the Subway franchise. The Court of Appeal dismissed the appeal, finding that the legislative test, which focuses on the purpose for which food has been heated, did not give rise to any lack of certainty or unfairness based on the VAT principle of fiscal neutrality. Permission to bring a fresh challenge to that part of the legislative test which decides whether food is hot by reference to the ambient air temperature was also refused.

Click to view a copy of the judgment in Sub One v HMRC

 

Melanie Hall QC, representing HMRC, led Ewan West of Monckton Chambers and Owain Thomas.