Healthcare

Array ( [0] => WP_Post Object ( [ID] => 20519 [post_author] => 9 [post_date] => 2021-12-17 14:21:52 [post_date_gmt] => 2021-12-17 14:21:52 [post_content] => Welcome to the latest update from the Philip Lee Healthcare, Pharmaceuticals and Life Science group. This update covers a range of topics: General Regulatory – Ireland 1. The Irish Pharmaceutical Healthcare Association (“IPHA”) and Minister for Health agree Framework Agreement on Pricing and Supply of Medicines 2021 – 2025 2. Medicines for Ireland (“MFI”) and Minister for Health agree Framework Agreement on Pricing and Supply of Medicines 2021 – 2025 3. IPHA has released a standardised model Clinical Trial Agreement (“mCTA”) for use in all interventional clinical trials in Ireland 4. Healthcare a key focus under the National Development Plan (“NDP”) 2021-2030 and under Budget 2022 5. New Intellectual Property List created as sub-division of the Irish High Court’s Commercial List General Regulatory – EU 6. European Commission to Table Legislation to Ensure Continuity of Supply of Medicines to and from Northern Ireland 7. New EU Clinical Trial Regulation 8. Commission proposes extension to transitional period of the In Vitro Diagnostics Medical Devices Regulation 2017/746 (the “IVDR”) 9. European Commission Public Consultation on a Reform of EU Pharmaceutical Legislation 10. Publication of an Implementing Regulation of Good Distribution Practice for Veterinary Medicinal Products in accordance with Regulation (EU) 2019/6 11. Consultation outcome on cross border healthcare / Evaluation of patients’ rights 12. New EU Health Emergency Preparedness and Response Authority established (“HERA”) 13. Proposal for IP waiver for COVID-19 vaccines 14. EU Strategy on COVID-19 Therapeutics Strategy – 5 promising treatments identified by the Commission in the EU Strategy on COVID-19 Therapeutics 15. European Commission signs Contract for Supply of Monoclonal Antibody Treatment. Global Insights 16. Molnupiravir pill from Merck: the first oral anti-viral Covid-19 drug seeks US approval Competition Law 17. Competition and Consumer Protection Commission (CCPC) Publish 2020 Annual Report 18. Competition (Amendment) Bill 2021 19. European Commission scrutinising Illumina/Grail transaction 20. Imposition of fines by UK Competition and Markets Authority (CMA) for the placing of excessive prices on hydrocortisone tablets Data Protection 21. Data Protection Commission (DPC) guidelines regarding return to in-person work / employers not allowed to inquire as to employees’ vaccination status 22. European Data Protection Board (EDPB) adopts guidelines on restrictions under Art 23 GDPR 23. EDPB adopts draft guidelines on GDPR provisions on international transfers (Chapter V) and territorial scope (Article 3)   To read the full update see: Healthcare, Pharmaceuticals and Life Sciences Update. [post_title] => Healthcare, Pharmaceuticals and Life Science Update [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => healthcare-pharmaceuticals-and-life-science-update [to_ping] => [pinged] => [post_modified] => 2021-12-17 14:21:52 [post_modified_gmt] => 2021-12-17 14:21:52 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.philiplee.ie/?p=20519 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) )

Array ( [0] => WP_Post Object ( [ID] => 18719 [post_author] => 9 [post_date] => 2021-01-04 16:04:06 [post_date_gmt] => 2021-01-04 16:04:06 [post_content] => The much-anticipated final Expert Group Report to Review the Law of Torts and the Current Systems for the Management of Clinical Negligence Claims, chaired by Mr Justice Charles Meenan (the Report), issued with little fanfare prior to Christmas. The Report which can be accessed here contains 17 recommendations summarised as follows:

• As clinical negligence claims involve issues that do not arise in other personal injury actions, practices and procedures must be introduced to reflect this;
• Pre-action protocols to be implemented together with the commencement of the provision extending the Statute of Limitations period from two years to three years;
• Procedures allowing for the case management of clinical negligence claims to be implemented;
• That there be a dedicated list in the High Court to deal with the management and hearing of clinical negligence claims;
• That medical records, when requested, are provided in a timely way and in a legible form;
• That failure to comply with the requirements of pre-action protocols should be penalised with costs or, where there is persistent non-compliance, an order to dismiss the claim or defence;
• That s. 26 of the Civil Liability and Courts Act, 2004 be amended to provide for sanctions where a defendant files a defence containing matters in respect of which there is no supportive expert report.
• The Expert Group does not recommend the introduction of a no-fault system to deal with certain clinical negligence claims;
• The establishment of a compensation scheme to deal with certain vaccine damage claims;
• The Expert Group does not recommend the establishment of a Medical Injuries Assessment Board (MIAB);
• That a system for the “restoration of trust”, as provided for in Chapter 5 of the CervicalCheck Tribunal Act, 2019, be made available for other clinical negligence claims;
• Ex gratia payment schemes only have limited application;
• That care packages provided by the HSE be funded so as to reduce the difference between what the HSE can offer and what a court would award;
• That the disclosure of certain patient safety incidents be made mandatory;
• That failure to make a disclosure, when required by law to do so, should be considered to be either professional misconduct or poor professional performance by the healthcare provider involved, and should be the subject of an inquiry by the relevant professional body;
• It should be a criminal offence for a healthcare provider: - (i) to deliberately fail to make a disclosure of a serious reportable patient safety incident when required by law to do so; (ii) to alter medical records with the intent to mislead or deceive;
• That the provisions of the Health Act, 2007 be amended so as to enable HIQA to carry out investigations other than those currently provided for.

Pre-action protocols Let us hope that this is the final report in which pre-action protocols are recommended.  Let us hope also that there is little delay in bringing about these much-needed reforms.  Having worked in this area of the law in the UK, the writer can attest to the significant efficiencies that can be achieved with the use of mandatory pre-action protocols in the management of even the most complex clinical negligence claims.  The protocols encourage co-operation and provide for the narrowing of issues in dispute between the parties.  However, in order for the protocols to work effectively, it is also important for the parties to be compelled to address the issue of quantum in a meaningful way at the pre-action stage which in turn will allow for realistic offers of settlement much earlier in the life of the claim. Witness statements The Report also recommends the provision of witness statements, the entirely laudable rationale for this being to avoid claimants having to give evidence of a personal or intimate nature in open court.  The Report posits that the adversarial aspect of a court hearing could be confined to resolving disputes between suitably qualified experts.  The writer has long advocated for the use of witness statements of fact in clinical negligence actions in Ireland similar to other common law jurisdictions.  Witness statements can be a crucial part of the case, designed to give advanced notice of the evidence to be relied on at trial, allowing the parties and, most importantly, their experts to be better prepared and thus reducing the element of surprise. However, the Report suggests that the use of witness statements could potentially remove the need for the claimant to give evidence in court unless he or she wishes to do so.  The likelihood is that such statements would only replace the evidence-in-chief of the witness.  Each party must surely retain the right to cross-examine their opponent's witness in order to "test" the cogency of the evidence and the witness’s credibility.   In such circumstances, unfortunately, the claimant would still have to submit to cross-examination on his or her evidence. Case management The Expert Group recommended the implementation of the excellent case management proposals set out in the report of the Working Group on Medical Negligence and Periodic Payments (Module 3) which, the Expert Group say, would considerably improve the current system to the benefit of the litigants involved. However, The Expert Group also notes that, “whilst proposed rules have been circulated for the implementation of pretrial protocols and a Statutory Instrument is being drafted, there has been no such progress in the introduction of case management”. Case management is an essential tool for the purposes of controlling lengthy, complex and potentially unwieldy clinical negligence cases.  It is critical that we do not miss the opportunity to effect this reform in this highly sensitive area of the law. It is critical also, for the sake of all parties involved in these difficult cases, that reforms are not piece-meal.   For further information in relation to the above article, please contact Marie Kinsella. [post_title] => Philip Lee welcomes the final report of the Expert Group into the management of clinical negligence claims chaired by Mr Justice Charles Meenan [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => philip-lee-welcomes-the-final-report-of-the-expert-group-into-the-management-of-clinical-negligence-claims-chaired-by-mr-justice-charles-meenan [to_ping] => [pinged] => [post_modified] => 2021-01-04 17:12:40 [post_modified_gmt] => 2021-01-04 17:12:40 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.philiplee.ie/?p=18719 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) )

Array ( [0] => WP_Post Object ( [ID] => 11777 [post_author] => 9 [post_date] => 2020-09-21 14:14:28 [post_date_gmt] => 2020-09-21 14:14:28 [post_content] => The Civil Law and Criminal Law (Miscellaneous Provisions) Act 2020 (“the Act”) is now in force. It was introduced by the Irish Government in response to the challenges posed in the wake of the COVID-19 pandemic and seeks to meet the immediate difficulties faced in civil and criminal proceedings. Chief among the provisions introduced by the Act are the following:

• the introduction of statements of truth instead of affidavits and statutory declarations;
• the introduction of a statutory basis for courts to conduct remote hearings in civil proceedings;
• the admissibility of business records as evidence in civil proceeding;
• the lodgement of documents with the courts by electronic means, or e-filing;
• provision for the wider use of video links between persons in custody and the courts;
• enhancing and widening the existing provisions on giving evidence through video link;
• providing for appeals (to the Court of Appeal and the Supreme Court) in criminal proceedings to take place via remote hearing;
• providing for the remote meetings of State bodies;
• provisions making it easier to alter the operating hours and sitting locations of the District Court.

Statements of truth and the move away from affidavit evidence A most welcome provision of the Act is the introduction in Section 21 of a ‘statement of truth’ as an alternative to sworn affidavits and statutory declarations in civil proceedings as governed by the Oaths Acts 1838, 1888 and 1909. These statutes require the deponent to hold a religious text and swear the document before God (with provisions for members of other faiths and for making of an affirmation). Although a long-standing feature of Irish Court proceedings, there have long been calls to abolish the need for affidavits in civil and criminal proceedings. In its 1990 Report on Oaths and Affirmations, the Law Reform Commission (“LRC”) made six main recommendations including that the oath should be abolished for witnesses and jurors, and for deponents filing affidavits in civil or criminal proceedings. It recommended the use of affirmations instead of the requirement that “persons […] have a belief in a supreme being to whom they are answerable.”  The LRC explored the various forms of oath appropriate for members of different faiths and pointed out that swearing an oath on a religious text is, in fact, contrary to the teachings of some faiths. It has also been commented upon that the practice of requiring a witness to indicate their religious faith when submitting evidence is embarrassing, archaic and does not have any place in a modern, pluralist society. Changes arising from COVID-19 Recently, the unprecedented COVID-19 pandemic has resulted in practical difficulties for deponents filing affidavits. The distancing measures in place mean that the usual practice of attending in person before an independent solicitor or commissioner for oaths to swear a document presented challenges. While the pandemic has undoubtedly hastened these reforms, the provisions of section 21 of the Act are not limited to any interim period or time of emergency and as such, appear to be here to stay. Section 21 provides that a statement of truth may be made and transmitted electronically, may be signed electronically by the person making it, and ought to:

• Contain a statement that the person making the statement of truth has an honest belief that the facts stated therein are true; and
• Complies with any other requirements that may apply.

In practice, it can be assumed that the statement itself would follow a similar format to the manner in which facts are set out on affidavit, with a declaration signed by the person making the statement that the facts contained therein are true and accurate. The provision that a statement of truth may be signed electronically is also welcomed, given the recent move to conducting business, and court business, remotely and the more frequent use of electronic signature. However, the making of a statement of truth should be taken no less seriously than swearing an affidavit or signing a Statutory Declaration - section 21(4) states that a person who makes a statement of truth without an honest belief as to the truth of that statement shall be guilty of an offence, notwithstanding the law in relation to contempt of court.  The statutory penalties for such an offence are severe and, pursuant to section 21(5), are:

• on summary conviction, a class A fine or imprisonment for a term not exceeding 12 months or both;
• or upon conviction on indictment, to a maximum fine of €250,000 or imprisonment for a term not exceeding 5 years, or both.

Court Rules   While the Act makes provision for statements of truth, section 21(1) explicitly requires amendment to the Rules of Court to give this provision effect.  Such Rules would likely set out in detail any additional requirements in respect of format, content, verification and authentication. It is envisaged that the relevant Court Rules will be amended swiftly to alleviate the stress on practitioners and clients alike associated with executing sworn documents. It would also appear that the Court Rules have a degree of latitude when it comes to the finer details of statements of truth as  the Act also provides that Rules of Court may make provision for a statement to be made and transmitted by electronic means “subject to such conditions and exceptions as may be specified by such rules.” Conclusion and further observations While the LRC report observed a gradual legislative move towards statutory declarations rather than sworn affidavits, the introduction of statements of truth goes further in removing entirely the requirement for a solicitor or commissioner for oaths. Further, a person’s religious beliefs are now a special category of personal data under the GDPR.  Statements of truth will ensure the protection of the dignity and privacy of persons as they will no longer be required to declare their religious beliefs in order to execute a legal document. However, these reforms apply only in respect of affidavits and statutory declarations in litigation and not other civil matters such as probate or conveyancing. Additionally, jurors and witnesses giving evidence viva voce in Court will still be required to swear an oath in advance of providing such testimony. President of the Law Society, Michele O’Boyle, welcomed the reforms that reflect our diversity and inclusivity today, but noted that the Act does not go far enough. She stated further reforms are necessary and these would be actively pursued. It is clear that while the Act makes significant progress in respect of the function of the court in these challenging times and beyond, further Rules of Court are necessary to fully implement the statements of truth so they may be invoked in proceedings going forward, and without delay. Further, introducing statements of truth in litigation matters only is insufficient and further legislative reform is urgently needed so that all areas of law can benefit from these advancements in procedure.   For any further information, please contact Marie Kinsella, Jennifer Darcy, or a member of the healthcare litigation team. Article written with the assistance of Darragh Bollard.   [post_title] => Stating the truth - The Civil Law and Criminal Law (Miscellaneous Provisions) Act 2020 [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => stating-the-truth-the-civil-law-and-criminal-law-miscellaneous-provisions-act-2020 [to_ping] => [pinged] => [post_modified] => 2020-09-21 14:24:45 [post_modified_gmt] => 2020-09-21 14:24:45 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.philiplee.ie/?p=11777 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) )