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Healthcare, Pharmaceuticals and Life Sciences Update

Sunday, June 30, 2019


  • General Regulatory – Ireland
  • General Regulatory – EU
  • Brexit
  • Competition Law



  1. Falsified Medicines Directive

In 2018, the HPRA detained 619,213 dosage units of illegal medicines. Therefore, the European Commission’s Delegated Regulation on safety features for medicinal products for human use (which came into force on 9 February 2019) has arrived at an appropriate time. Delegated Regulation (EU) 2016/161 supplements the Falsified Medicines Directive 2011/62/EU by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use.

All medicinal products released by marketing authorisation holders for the Irish market after 9 February 2019 should bear the safety features as required i.e. (a) a 2D barcode and (b) an anti-tamper device. The Irish Medicines Verification Organisation (“IMVO”) has been established to manage the medicines verification system for Ireland and the majority of pharmacies, wholesalers, MAH’s and manufacturers have registered with the IMVO.

If a pharmacist or wholesaler (or indeed anyone present on the supply chain of the product in question) has reason to believe that packaging has been interfered with, based on their examination of the anti-tampering device on the pack, they must report their concern to the HPRA.

  1. HPRA has updated its 2013 Guideline on Good Distribution Practice of Medicinal Products for Human Use

The 2019 updated guide (with tracked changes) can be found here.  

New sections on verification of safety features and decommissioning of unique identifiers prior to supply have been added.



  1. New Medical Devices Regulations – EMA Guidance

On 25 May 2017 Regulation (EU) 2017/745 on medical devices (“the Medical Devices Regulation”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“the IVD Medical Devices Regulation”) replaced the three existing medical device Directives (93/42/EEC, 98/79/EC and 90/385/EEC). These two new regulations will come into full application in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices. In response to this, the European Medicines Agency (the “EMA”) has published guidance outlining the new duties arising from the change in legislation.

The first questions and answers (“Q&A”) document deals with the implementation of Article 117 of the Medical Devices Regulation. This states that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body.

The EMA intends to publish further updates to the Q&A document addressing other requirements for various categories of devices, including those made of substances that are systemically absorbed, products which are not clearly defined as medicinal products, known as “borderline products”, and in vitro diagnostic tests used to determine patients’ eligibility for a specific medical treatment.

  1. New IFPMA Code of Practice

A new Code of Practice of the International Federation of Pharmaceutical Manufacturers and Associations (“IFPMA”) has been introduced, heralding a number of significant changes. For example, it is now prohibited for companies to offer gifts and professional aids to healthcare professionals. The purpose of this ban is not only to avoid unprofessionalism within the healthcare industry, but more importantly to place the focus firmly on the patient’s best interest. The new Code contains a different approach – from a rules based approach to a code grounded in ethos, namely “care, honesty, fairness and respect.”

See the full text of the Code of Practice here.

  1. Opinion on the interaction between the Clinical Trials Regulation and the General Data Protection Regulation

The European Data Protection Board (“EDPB”) has adopted an Advisory Opinion (the “Opinion”) discussing the interaction between Regulation (EU) 536/2014 (the “Clinical Trials Regulation”) and the General Data Protection Regulation (the “GDPR”). The Opinion discusses (1) the primary use and (2) the secondary use of clinical data (the use of clinical data for scientific functions outside the clinical trial protocol).

Examples of primary uses of clinical data would be processing operations relating to reliability and safety purposes. Under Article 6(1) (c) of the GDPR, organisations may rely on a legal obligation to which they are subject under EU law or under the laws of an EU country to justify their processing operations. The EDPB considers that the processing of sensitive data for reliability and safety purposes in the context of clinical trials could rely on the fact that the processing is necessary for reasons of public interest in the area of public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of EU law or an EU country law, Article 9(2) (i) GDPR. According to the EDPB, this would correspond with the necessity to comply with a legal obligation under Article 6 GDPR. The Clinical Trials Regulation requires entities that perform clinical trials to process personal data for reliability and safety purposes – the Opinion confirms that this “legal obligation” ground permits the processing of personal data in this context.

The Opinion also discusses the legal basis for processing sensitive data when conducting clinical trials for research purposes – the legal basis identified under Article 6 GDPR shall be applied only if Article 9 GDPR provides for a specific derogation from the general prohibition to process sensitive data.

  1. New mutual recognition agreement between the Swiss agency for therapeutic products (Swissmedic) and the Eudra GMDP Database allowing Swissmedic “read and write” access

Swissmedic, the Swiss authority responsible for the authorisation and supervision of therapeutic product, will now have “read and write” access to the EudraGMDP database. Swissmedic is committed to align on the EU framework since it has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This new provision is part of a mutual recognition agreement (MRA) between the EU and Switzerland that entered into force in 2002.

If you want more information about the EU-Swiss MRA, please click here.

  1. Five additional countries to benefit from EU-US mutual recognition agreement for inspections

The US Food and Drug Administration (“FDA”) confirmed the capability of five additional EU Member States (Bulgaria, Cyprus, Luxembourg, The Netherlands and Germany) to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to the United States. The move is part of a wider EU-US agreement where the FDA and the EU will be able to rely on each other’s GMP inspections and is planned to be fully operational by 15 July 2019. The inclusion of these countries brings the total number of EU Member States to 27 which are now party to mutual recognition of GMP testing.

  1. 1.7% increase of fees payable to EMA from 1 April 2019

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders increased by 1.7% on 1 April 2019.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.


  1. Batch testing exemption

Medicinal products imported into the EU must undergo quality control testing (also known as batch testing) at batch release sites established in the EU/EEA to ensure the quality of medicinal products being placed in the Union market. Authorisation holders must comply with this requirement by the withdrawal date, which may result in moving batch testing sites from the United Kingdom to within the EU27.

In February 2019, the European Commission acknowledged that there may be “objective reasons beyond the control of the marketing authorisation holders that may prevent timely transfer of such testing activities to the Union by the withdrawal date.” Accordingly, the Commission introduced an exemption allowing competent authorities to permit marketing authorisation holders to rely on quality control testing performed in the United Kingdom for an extended period of time – until 31 December 2019 (subject to certain conditions).

Marketing authorisation holders have been encouraged to immediately notify the relevant national competent authority that granted the marketing authorisation (or the EMA in case of centrally authorised products). However, the original 29 March notification deadline has been extended to the new withdrawal date (currently set for 31 October 2019).

The EMA has reportedly approved approximately 50 out of 60 applications from drug companies applying for the temporary batch testing exemption.

  1. EMA advice in relation to medicinal products vis-à-vis Brexit

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure have been drafted jointly by the European Commission and the EMA. The guidance addresses the situation where the United Kingdom becomes a third country without a withdrawal agreement and hence without a transition period provided for in the draft withdrawal agreement. If that is the case, the following is relevant:

    • Products that only have batch release and quality control testing sites for finished product in the UK will have to change the batch release and testing sites. For finished products manufactured in the UK an importation site (in the EEA) will need to be introduced;
    • For medicinal products that are co-packaged (but do not form a single integral product) with a medical device for which the conformity assessment to support the CE marking was performed by a UK notified body, it will be necessary to either update the marketing authorisation dossier with evidence supporting the CE marking by a new notified body, or remove the medical device from the pack, or replace the device with an alternative medical device with a valid CE mark; and
    • In preparation for the UK’s withdrawal from the Union, a marketing authorisation holder currently established in the UK will need to be replaced with a marketing authorisation holder established in one of the remaining countries of the EEA. This change in marketing authorisation holder requires an application for a transfer of a marketing authorisation from the current UK-based holder to a different legal entity established in the EEA.

For more information, click here.

  1. EU actions to prevent medicine shortages due to Brexit

The EMA has recently published a question and answers document for patients, healthcare professionals and the general public on the preparatory work that EU authorities are doing to prevent medicine shortages due to the UK’s withdrawal from the EU in both a “no-deal scenario” and in the case of a withdrawal agreement.

Click here to read the full report.



  1. Antitrust concerns in the Irish pharmaceutical sector?

Clinical director of the National Centre for Pharmacoeconomics, the body that advises the Health Service Executive (“HSE”) on the cost-effectiveness of medicines, stated in a recent interview that pharmaceutical companies may be pursuing “predatory pricing” for new medicines. The Irish Pharmaceutical Healthcare Association, which represents pharma companies said the accusation is “baseless” and amounted to an “accusation of illegality against the industry”. A spokesperson for the Competition and Consumer Protection Commission in Ireland has confirmed that the pharmaceutical sector in Ireland is being monitored following concerns raised regarding pricing issues, according to media reports.

Unfair pricing imposed by a dominant undertaking may amount to an abuse of dominance which is unlawful under both Irish competition law rules and EU law. Companies found to have abused their dominance in Ireland face a maximum fine of €5 million or 10 per cent of turnover, whichever is greater.

  1. Continued European and national competition law based scrutiny to continue in the pharmaceutical sector

The European Commission published a report on competition enforcement in the pharmaceutical sector following market monitoring in the area during the period  2009-2017. During this time European competition authorities investigated more than 100 cases, sanctioning companies in 21 cases and imposing fines for more than €1 billion. Over 20 cases of possible antitrust infringements are currently subject to ongoing investigation.

In summary, the report shows that antitrust concerns in the sector led to intervention decisions arising primarily from abuses of dominance. Examples of such abuse included firms charging excessive prices for medicines. The implementation of restrictive agreements between competitors such as pay for-delay agreements is also identified as another concern because this practice may have the effect of preventing generic brands entering the market. The report indicates that mergers in the pharmaceutical sector may also raise competition concerns if there is a risk of price increases for medicines or the prevention of innovation.

The report concludes that antitrust tools and enforcement combined with merger control are a means to enhance innovation and to increase the choice in medicines. Building on their strong expertise in the field, the European Commission and domestic Member State competition authorities will keep scrutinising the pharmaceutical sector to ensure it remains at a competitive level in the future considering its impact on health and finance across the European Union.

To read the full report, click here.

  1. Flynn and Pfizer v Competition and Market Authority (CMA)

The long running dispute between Flynn and Pfizer and UK competition authorities involved another skirmish recently with a ruling on costs in the matter on 29 March.

Back in December 2016, the CMA had found that Pfizer and Flynn Pharma abused their respective dominant positions by charging excessive prices for phenytoin sodium capsules in the UK. The CMA fined Pfizer £84.2 million and Flynn Pharma £5.2 million. On 7 June 2018, the Competition Appeal Tribunal (the “CAT”) gave its judgment on Flynn and Pfizer’s appeal, upholding the CMA’s finding on dominance but, more importantly, setting aside the CMA’s finding of abuse. The CAT held the CMA failed to identify an appropriate benchmark which would have applied in conditions of normal and sufficiently effective competition. Identifying a benchmark would indicate the economic value of the medicine to determine whether excessive pricing had actually taken place.

It is difficult to determine whether a price is excessive; the CAT’s judgment confirms that a market in the pharmaceuticals sector can be defined narrowly but it set a high burden of proof on how excessive pricing might characterise an abuse of dominance.

The recent costs ruling effectively stayed the matter until the Court of Appeal has ruled on the appeals in this case. The CMA appealed the CAT’s decision on a number of grounds, which commentators presume is because it has a number of other investigations which may hinge on the CAT’s judgment.

  1. Update to administrative timetables for CMA investigation into alleged breaches of competition law within the pharmaceutical sector:

The CMA is currently investigating alleged anti-competitive agreements and/or concerted practices and suspected abuse of dominance in relation to a product within the pharmaceutical sector under Chapters I and II of the Competition Act 1998 as well as Articles 101 and 102 of the Treaty of the Functioning of the European Union (“TFEU”). As part of the investigation, the CMA is to decide whether a statement of objections can be issued.

On 18 June 2019 the CMA announced that further time was required in order to gather and analyse information. Accordingly, the date for completing its investigation has changed from June 2019 to November 2019. This is the third time that the CMA have sought an extension to gather information in relation to this particular investigation.

  1. CMA issue statement of objections in relation to suppliers of antidepressants accused of illegal anti-competitive conduct

The CMA has accused competitors King, Auden McKenzie, Alissa and Lexon of dividing the supply of an anti-depressant, nortriptyline, to a large pharmaceutical wholesaler.

It has been purported that commercially sensitive information was exchanged between parties in order to maintain high prices for nortriptyline. In a statement of objections, the CMA has indicated that such infringements fall under Section 2(1) of the Competition Act 1998 and Article 101 (1) of the TFEU. The Director of Competition, Geoff Steadman, said: “If pharmaceutical companies get together to restrict competition for the supply of a drug, this can lead to the NHS – and ultimately the UK taxpayer – paying over the odds for what are often essential medical treatments.

This is the CMA’s provisional finding, meaning that the parties in question now have the chance to make representations to the CMA before it reaches a final decision.

  1. French national competition authority reports on distribution in the pharmaceutical sector

The French national competition authority, the Autorité de la Concurrence, put forward a package of measures that could be implemented to foster competition in the French pharmaceutical sector following its latest report relating to the sector. These recommendations include:

    1. The removal of regulatory constraints for online sales of un-prescribed medicine. This is intended to allow pharmacists to pool resources to sell medicine through joint online platforms;
    2. The liberalisation of the sales of non-prescribed drugs so that they could be available to purchase by consumers in supermarket outlets; and
    1. The wholesalers of subsided medicine should be paid based on the volume of medicine sold rather than on the price of the drug at face value.

Under French law, pharmacies have a legal monopoly to sell medicine. The French competition authority’s recommendations on improving competition within the French pharmaceutical sector are merely a policy recommendation. Regulatory and legislative action must follow, therefore, for these measures to be introduced.



Ronan Dunne