Medicines And Medical Devices Act 2021

Schedules

Schedule 1: Further Provision about the Commissioner for Patient Safety

Principles relating to core duties

307. Paragraph 1(1) places a duty on the Commissioner to prepare and publish a set of principles to govern the way in which the Commissioner will carry out their core duties.
308. Paragraph 1(2) allows the Commissioner to revise these principles and requires any revised versions to be published.
309. Paragraph 1(3) sets out that the Commissioner must carry out a public consultation when preparing or revising the principles.

Involvement of patients

310. Paragraph 2(1) requires the Commissioner to take reasonable steps to involve patients in the discharge of their core duties.
311. Paragraph 2(2)(a) requires the Commissioner to take reasonable steps to ensure that patients are aware of the Commissioner’s core duties and of how they may communicate with the Commissioner.
312. Paragraph 2(2)(b) requires the Commissioner to take reasonable steps to consult patients on matters which the Commissioner proposes to consider in the discharge of their core duties.

Supplementary functions and information

313. Paragraph 3(1) sets out the supplementary functions the Commissioner may exercise for the purposes of carrying out their core duties. These include making reports or recommendations to relevant persons; consulting patients and appropriate persons; as well as requesting information from and sharing information with, relevant persons.
314. Paragraph 3(2) provides that a relevant person to whom a report or recommendation is made must provide a response within such period as the Commissioner may reasonably require.
315. Paragraph 3(3) sets out that a relevant person must, so far as reasonably practicable, comply with a request for information within such period as the Commissioner may reasonably require.
316. Paragraph 3(4) outlines that nothing in Schedule 1 authorises a disclosure of information which contravenes data protection legislation. ‘Data protection legislation’ has the meaning given by section 3(9) of the Data Protection Act 2018.
317. Paragraph 3(5) provides definitions. It outlines that in paragraph 3 "relevant person" means a person who exercises functions of a public nature in England in relation to medicines and medical devices; and any other person who, in the course of providing health care, provides services relating to medicines or medical devices in relation to England.

Individual cases

318. Paragraph 4(1) prevents the Commissioner from exercising functions in relation to an individual case.
319. Paragraph 4(2) provides that this does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue.

Amendments to primary legislation

320. Paragraph 5 makes various amendments to primary legislation relating to the Commissioner for Patient Safety.
321. Paragraph 5(1) amends Schedule 1 to the Public Records Act 1958 to include the Commissioner for Patient Safety. This provides for the Commissioner’s records to be regarded as public records.
322. Paragraph 5(2) amends Schedule 1 to the House of Commons Disqualification Act 1975. The effect is that the Commissioner cannot also be a Member of Parliament.
323. Paragraph 5(3) amends Schedule 1 to the Freedom of Information Act 2000 to bring the Commissioner within the Act’s definition of a "public authority". This makes the Commissioner subject to relevant provisions of that Act.
324. Paragraph 5(4) amends section 71 of the National Health Service Act 2006 (schemes for meeting losses and liabilities etc. of certain health service bodies). This means that the Commissioner will be eligible to participate in indemnity schemes established under that section. This does not mean that the Commissioner will automatically be a member of any such scheme.
325. Paragraph 5(5) amends Schedule 19 to the Equality Act 2010 (authorities subject to the public sector equality duty) to include the Commissioner.

Regulations about appointment and operation

326. Paragraph 6(1) provides a power for the Secretary of State to make provision in regulations about the appointment and operation of the Commissioner for Patient Safety.
327. Paragraph 6(2) sets out a list of matters regulations may (among other things) contain provision for and about. These include the Commissioner’s terms of office; the provision of financial or other assistance, including staff, accommodation, equipment or other facilities for the Commissioner; and the appointment of a board to provide advice to the Commissioner.

Schedule 2: Medical Devices: Civil Sanctions

Part 1: Monetary Penalties

Imposition of monetary penalty

328. Schedule 2 outlines how the new civil sanctions regime for medical devices will operate. Part 1 relates to monetary penalties.
329. Paragraph 1 provides that the Secretary of State may impose a monetary penalty on a person who he is satisfied beyond a reasonable doubt has committed an offence under section 28 of this Act or regulation 60A of the MDR (that is, the offence of breaching a provision listed in the last Schedule to the MDR, inserted by Schedule 3 to the Act and explained below). The amount payable is determined by the Secretary of State.

Notices, representations and appeals etc

330. Paragraph 2 provides that the Secretary of State must notify a person on whom he is planning to impose a monetary penalty before doing so. That notice must give the person the opportunity to discharge their liability by paying less than, or an equal amount to, the penalty. The person will then also have the opportunity to write to, or object to the Secretary of State regarding the penalty. Following this, the Secretary of State must then decide whether or not to proceed with the penalty.
331. Paragraph 2(5) provides that the Secretary of State cannot issue a monetary penalty if he is no longer satisfied with the reasons for doing so.
332. Paragraph 2(6), sets out the circumstances in which the person who has been issued with the penalty may appeal. Any such appeal is to the First Tier Tribunal. The First Tier Tribunal is made up of 7 chambers which settles legal disputes and is structured around particular areas of law.
333. Paragraph 2(8) provides that the Tribunal must allow the appeal if the appellant claims they did not commit an offence, unless they believe beyond reasonable doubt that they did. This is the same standard of proof as required by a criminal offence.

Information to be included in notices under paragraph 2

334. Paragraph 3 sets out what must be included in the notice provided by the Secretary of State to the person(s) he is considering imposing a monetary penalty on.

Monetary penalties: criminal proceedings and conviction

335. Paragraph 4 provides that a person may not be subject to any criminal proceedings in relation to the conduct that has led to the imposition of the monetary penalty if they have paid the penalty, or before the allowed time between the notice and paying the penalty.

Part 2: Enforcement Undertakings

336. Part 2 outlines "enforcement undertakings". These provisions allow a person to offer to take certain action within a specified time as a result of the Secretary of State suspecting (on reasonable grounds) that they have committed an offence under section 28 or under regulation 60A of the MDR. The action taken can either be to ensure the offence does not occur again, or as set out in the supplementary regulations. The Secretary of State has the power to accept an enforcement undertaking.
337. Paragraph 5(2) provides that the person cannot be convicted of an offence, or subject to a monetary penalty, in relation to the action that led to the offer of the enforcement undertaking, unless they have failed to comply with the undertaking.

Part 3: Enforcement Costs Recovery Notices

Imposition of enforcement costs recovery notices

338. Paragraph 6 provides that the Secretary of State has the right to issue a notice to the person on whom a monetary penalty has been imposed in order to recoup the costs of issuing the penalty. These costs include administration costs, investigation costs, and the costs of obtaining expert advice (including, but not limited to, legal advice).

Information to be included in enforcement costs recovery notices

339. Paragraph 7 outlines what must be included in an enforcement costs recovery notice. It states that the person who received an enforcement costs recovery notice can ask the Secretary of State for a detailed breakdown of costs.

Appeals

340. Paragraph 8 sets out the grounds on which a person on whom an enforcement costs recovery notice has been served can appeal. An appeal is to the First Tier Tribunal.

Part 4: Power to Make Supplementary Provision etc by Regulations

Supplementary regulations: general

341. Paragraph 9 gives the Secretary of State the power to make regulations, as set out in paragraphs 10 to 12, to supplement the civil sanctions regime set out in Schedule 2 ("supplementary regulations"). The Secretary of State may also make consequential, incidental, transitional, transitory or saving regulations using this power. Paragraph 9(2) provides that regulations under this power may make different provision for different purposes, different provision for different areas and/or provision for all cases to which the power applies, or for specified cases or descriptions of cases.

Monetary penalties and costs

342. Paragraph 10 provides that supplementary regulations can make certain provision in relation to monetary penalties, specifically provisions relating to early payment discounts, interest on payments or other financial payments as a result of late payments (this may not exceed the total cost of the penalty), and enforcement. Provisions relating to enforcement can include provision for the recovery of the costs and/or penalties as civil debt and also under a court order.

Enforcement undertakings

343. Paragraph 11 sets out the matters relating to enforcement undertakings that can be set out in supplementary regulations, being:
     1. how a person can enter into an undertaking;
     2. the terms of an undertaking;
     3. when/how the Secretary of State can publish an undertaking;
     4. variation of an undertaking;
     5. what constitutes compliance with an undertaking;
     6. how the Secretary of State can monitor compliance;
     7. how the Secretary of State can issue a certification of compliance for the undertaking;
     8. the ability to appeal against the Secretary of State’s decision to refuse certification of compliance;
     9. provision that where a person has given inaccurate, misleading or incomplete information in relation to an undertaking, that person is to be regarded as non-compliant;
     10. provision that where an enforcement undertaking has only been partly complied with, the partial compliance should be taken into account when considering imposing any sanctions to be imposed on that person.

Appeals

344. Paragraph 12 provides that supplementary regulations may make provision with respect to the appeals process in relation to the imposition of a requirement or the service of a notice under the civil sanctions provisions. Sub-paragraph (2) provides that supplementary regulations may confer powers on the tribunal to which the appeal can be made, including to withdraw/confirm the requirement/notice, to take certain steps or to require that the decision be reconsidered by the Secretary of State.

Part 5: General and Supplemental

Guidance as to enforcement

345. Paragraph 13 requires the Secretary of State to prepare and publish guidance with regard to enforcement and civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.
346. Sub-paragraph (2) provides that the guidance must include information on the circumstances when, and the manner in which, the Secretary of State will impose a monetary penalty.
347. Sub-paragraph (3) similarly provides the guidance must include information on the Secretary of State’s powers to issue an enforcement costs recovery notice, and relevant information alongside this.
348. Similarly, sub-paragraph (4) provides that guidance must provide further information on the Secretary of State’s power to accept an enforcement undertaking.
349. Sub-paragraph (5) provides that the Secretary of State can revise the guidance published under this paragraph where it is appropriate to do so and must then publish the revised guidance.
350. Sub-paragraph (6) outlines who the Secretary of State must consult with before publishing any new or revised guidance.
351. Sub-paragraph (7) provides that the Secretary of State must have regard to the guidance whilst exercising any of the powers outlined in this Schedule.

Pre-commencement consultation

352. Paragraph 14 provides that consultation on either supplementary regulations made under section 45 (consultation), or guidance made under paragraph 13, that takes place before the Schedule comes into force, will satisfy the requirement to consult.

Reports on use of civil sanctions

353. Paragraph 15 provides that the Secretary of State must issue reports about the uses of the power in this Schedule and lists what each report must include.
354. However, the Secretary of State has discretion to refrain from including information in a report if in his opinion it would be inappropriate to do so on the basis that including this information might be unlawful or might adversely impact a current investigation or current legal proceedings.

Disclosure of information

355. Paragraph 16 provides that any relevant information held by the police, Crown Prosecution Service, a procurator fiscal, or the public prosecution service for Northern Ireland, may be shared with the Secretary of State for the purposes of exercising powers in this Schedule. Whether or not the information was obtained before or after the Schedule comes into force is irrelevant.
356. Sub-paragraphs (3) to (6) make clear that these powers do not enable disclosure of information in contravention of data protection legislation or in contravention of the relevant provisions of the Investigatory Powers Act 2016, but that, other than these restrictions, disclosure of information under paragraph 16 will not contravene other legislative or common law restrictions on the disclosure of information.

Part 6: Interpretation

357. This paragraph gives meaning to terms used in this Schedule.

Schedule 3: Offences of breaching provisions in the Medical Devices Regulations 2002

Part 1: Offence

358. Paragraph 1 inserts various regulations into the MDR.

60A Offence of breaching certain provisions

359. This inserted regulation outlines the definition of an offence under certain circumstances. The circumstances are defined as where a person fails to comply with a requirement or breaches a prohibition contained in a provision listed in the Schedule to the MDR inserted by Schedule 3.
360. Paragraph 2 sets the maximum penalties a person may be subject to if guilty of an offence. These are:
     1. As a result of a summary conviction in England and Wales, which is an offence that is only triable in a magistrates court, and is often summarised without the need for trial, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
     2. As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding £5,000, or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.
361. Paragraph 3 sets out the limitation period that applies in relation to the offence, which is the earlier of:
     1. the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor; and
     2. the end of the period of three years beginning with the day on which the offence was committed.
362. Paragraph 4 outlines that a certificate outlining the date on which the evidence came to the prosecutor’s knowledge and that is signed by the prosecutor is to be considered conclusive evidence that the evidence referred to above has come to the prosecutor’s knowledge.
363. Paragraph 5 outlines that the maximum 51 weeks imprisoned outlined in paragraph (2)(a) should be 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.

60B Defence of due diligence

364. This insertion sets out the defences available.
365. Paragraph (1) provides that a person being prosecuted for an offence under Regulation 60A can use the defence of due diligence if they can prove they took all reasonable steps to avoid committing the offence.
366. Paragraphs (2) and (3) provide that a person cannot, as part of their defence, claim that the offence was due to either another person’s action/default or to reliance on information provided by another person, unless they have first notified the prosecutor. That notification must include any information the defendant has that may assist in identifying the other person. The notification must be served at least 7 days before the hearing.
367. Paragraph (4) states that a person cannot rely on the defence of due diligence if they are relying on information provided by another person (as set out in paragraph 2(b)), unless the defendant can prove it was reasonable to rely on this information. This has to have regard to whether the defendant has reason to disbelieve the information, and steps taken to verify the information.
368. Paragraph (5) provides that in the application of regulation 60B to Scotland, references to the defendant are to be read as references to the accused and references to "the hearing of the proceedings" are to be read as "the trial diet".

60C Offences by bodies corporate

369. This insertion covers the offences committed by bodies corporate.
370. Paragraph (1) applies to offences committed by a body corporate.
371. It provides that an "officer" can also be prosecuted for committing an offence, if an offence has been committed under regulation 60A, by a body corporate (or, in the case of Scotland, a Scottish partnership) with the consent or knowledge of that "officer", or due to negligence of the "officer".
372. Paragraphs (2) to (4) set out the definition for "officer".

Part 2: Provisions

373. This Part inserts a Schedule into the Medicines Devices Regulations 2002 which sets out which provisions it is an offence to breach.