Medicines and Medical Devices Bill (HL Bill 163)

A

BILL

[AS AMENDED ON REPORT]

TO

Make provision about a Commissioner for Patient Safety in relation to human
medicines and medical devices; confer power to amend or supplement the law
relating to human medicines, veterinary medicines and medical devices; make
provision about the enforcement of regulations, and the protection of health
and safety, in relation to medical devices; and for connected purposes.

Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and
consent of the Lords Spiritual and Temporal, and Commons, in this present
Parliament assembled, and by the authority of the same, as follows:—

Part 1 The Commissioner for Patient Safety

1 Establishment and core duties etc

(1)The Secretary of State must appoint a Commissioner for Patient Safety
5(referred to in this Part as “the Commissioner”) to exercise the functions set out
in this Part in relation to England.

(2)The Commissioner’s core duties are to—

(a)promote the safety of patients with regard to the use of medicines and
medical devices, and

(b)10promote the importance of the views of patients and other members of
the public in relation to the safety of medicines and medical devices.

(3)The Commissioner is not to be regarded as the servant or agent of the Crown
or as enjoying any status, immunity or privilege of the Crown.

(4)Schedule 1 makes further provision about the Commissioner.

Medicines and Medical Devices BillPage 2

Part 2 Human medicines

Chapter 1 Regulations

2 5Power to make regulations about human medicines

(1)The appropriate authority may by regulations make provision specified in
sections 3 to 7 amending or supplementing the law relating to human
medicines for a period of three years beginning with the day on which this Act
is passed.

(2)10Regulations made under subsection (1) that introduce significant new policy or
significant changes to existing policy are subject, in relation to regulations
made by the Secretary of State, to the super-affirmative procedure set out in
section 51, in relation to regulations made by a Northern Ireland department,
to section 52, and, in relation to regulations of the Secretary of State and a
15Northern Ireland department acting jointly, to both.

(3)In making regulations under subsection (1), the appropriate authority’s
overarching objective must be safeguarding public health.

(4)In considering whether regulations under subsection (1) would contribute to
this objective, the appropriate authority must have regard to—

(a)20the safety of human medicines;

(b)the availability of human medicines;

(c)the likelihood of the relevant part of the United Kingdom being seen as
a favourable place in which to—

(i)carry out research relating to human medicines,

(ii)25conduct clinical trials, or

(iii)manufacture or supply human medicines.

(5)Where regulations under subsection (1) may have an impact on the safety of
human medicines, the appropriate authority may make the regulations only if
the authority considers that the benefits of doing so outweigh the risks.

(6)30In subsection (4)(c), “relevant part of the United Kingdom” means—

(a)so far as the regulations relate to England and Wales and Scotland,
those parts of the United Kingdom, and

(b)so far as the regulations relate to Northern Ireland, that part of the
United Kingdom.

(7)35In this Part, “appropriate authority” means—

(a)in relation to England and Wales and Scotland, the Secretary of State,
and

(b)in relation to Northern Ireland—

(i)the Department of Health in Northern Ireland, or

(ii)40the Department of Health in Northern Ireland and the Secretary
of State acting jointly.

Medicines and Medical Devices BillPage 3

3 Manufacture, marketing and supply

(1)Regulations under section 2(1) may make provision about—

(a)authorisations to manufacture human medicines,

(b)authorisations to import human medicines,

(c)5authorisations to distribute human medicines by way of wholesale
dealing,

(d)marketing authorisations,

(e)manufacturing, importing or distributing active substances,

(f)brokering in relation to human medicines,

(g)10the registration of the premises of pharmacy businesses,

(h)the recording of information about the supply of human medicines,

(i)notification and reporting requirements in relation to human medicines
that have been placed on the market,

(j)the labelling and packaging of human medicines or the information
15that must be supplied with them or made available in relation to them,

(k)advertising with regard to human medicines,

(l)the registration of persons who supply or offer to supply human
medicines by means of the internet,

(m)the requirements that must be met in relation to a prescription,

(n)20prohibitions in the provisions mentioned in subsection (2), or

(o)the use of tissues or cells (within the meanings given by regulation 5(1)
of the Human Tissue (Quality and Safety for Human Application)
Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.

(2)Subsection (1)(n) refers to the following provisions in the Human Medicines
25Regulations 2012 (S.I. 2012/1916)—

(a)regulation 214 and Schedule 13 (sale or supply of prescription only
medicines),

(b)regulation 215 and Schedule 14 (prescribing and administration by
supplementary prescribers),

(c)30regulation 220 (sale or supply of human medicines not subject to
general sale),

(d)regulation 221 and Schedule 15 (sale or supply of medicinal products
subject to general sale), and

(e)regulation 249 and Schedule 22 (restrictions on persons to be supplied
35with medicinal products).

4 Falsified medicines

(1)Regulations under section 2(1) may make provision about—

(a)the prevention of the supply of falsified human medicines, or

(b)the use, retention and disclosure, for any purpose to do with human
40medicines, of information collected for the purpose of preventing the
supply of falsified human medicines.

(2)Provision made in reliance on subsection (1)(a) may (among other things)
make provision—

(a)for human medicines that are subjects of a marketing authorisation to
45be supplied in packs that—

(i)carry unique identifiers associated with the products, and

(ii)are protected with anti-tamper devices,

Medicines and Medical Devices BillPage 4

(b)for checks to be carried out in relation to packs that have or should have
such a unique identifier,

(c)about the infrastructure, systems and processes required for the
allocation and checking of unique identifiers, including provision
5about—

(i)who is to set up the infrastructure, systems and processes,

(ii)who is to maintain them, and

(iii)who is to pay for them.

(3)In making regulations in reliance on subsection (1), the appropriate authority
10must have regard to the importance of ensuring that information is retained
securely.

5 Clinical trials

(1)Regulations under section 2(1) may make provision—

(a)corresponding or similar to provision in the EU Clinical Trials
15Regulation,

(b)about authorisations concerning clinical trials in the United Kingdom,
including applications for an assessment of the ethics of a proposed
clinical trial,

(c)about notification and reporting requirements in relation to clinical
20trials,

(d)about requirements that must be met before a clinical trial may be
carried out, or

(e)relating to the conduct of clinical trials.

(2)In subsection (1)(a), “EU Clinical Trials Regulation” means Regulation (EU) No
25536/2014 of the European Parliament and of the Council of 16 April 2014 on
clinical trials on medicinal products for human use, and repealing Directive
2001/20/EC.

6 Fees, offences, powers of inspectors

(1)Regulations under section 2(1) may make provision—

(a)30about the charging of fees in connection with the exercise of a function
conferred by a human medicines provision,

(b)creating a criminal offence of failing to comply with a provision made
in the regulations, or

(c)applying relevant powers of entry or other powers of inspectors with
35or without modification in relation to a prohibition or requirement in
provision made in the regulations.

(2)Regulations under section 2(1) may not provide for an offence to be punishable
with a sentence of imprisonment of more than two years.

(3)In subsection (1), “relevant powers of entry or other powers of inspectors”
40means powers of entry or powers of inspectors in—

(a)Part 8 of the Medicines Act 1968;

(b)the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I.
2004/1031);

(c)Part 16 of the Human Medicines Regulations 2012 (S.I. 2012/1916).

(4)45In this Part, “human medicines provision” means a provision in—

Medicines and Medical Devices BillPage 5

(a)regulations under section 2(1),

(b)the Human Medicines Regulations 2012, or

(c)the Medicines for Human Use (Clinical Trials) Regulations 2004.

7 Emergencies

(1)5Regulations under section 2(1) may make provision about the disapplication of
a human medicines provision in circumstances which give rise to a need to
protect the public from a risk of serious harm to health.

(2)Regulations made in reliance on subsection (1) may provide for the
disapplication to be subject to—

(a)10conditions set out in the regulations;

(b)conditions set out in a protocol published by the appropriate authority.

(3)Where regulations made in reliance on subsection (1) provide that the
appropriate authority may publish a protocol setting out conditions, the
regulations must provide—

(a)15that the appropriate authority may withdraw or amend the protocol,
and

(b)that the protocol is to have effect only for a period of time specified in
the protocol.

Chapter 2 20International agreements: disclosure of information

8 Disclosure of information in accordance with international agreements

(1)This section applies to information which a relevant authority holds in
connection with human medicines.

(2)The relevant authority may disclose information to a relevant person outside
25the United Kingdom where required for the purpose of giving effect to an
international agreement or arrangement concerning the regulation of human
medicines.

(3)Where information is disclosed in accordance with subsection (2) such
disclosure will only be permitted where—

(a)30it is required as part of international cooperation for
pharmacovigilance; or

(b)it is in the public interest.

(4)The relevant authority may not disclose commercially sensitive information in
reliance on subsection (2) unless the relevant authority—

(a)35considers that it is necessary to do so for the purpose mentioned in that
subsection, and

(b)is satisfied that the making of the disclosure is proportionate to what is
sought to be achieved by it.

(5)Except as provided by subsection (7), the disclosure of information in
40accordance with this section does not breach—

(a)an obligation of confidence owed by the person making the disclosure,
or

Medicines and Medical Devices BillPage 6

(b)any other restriction on the disclosure of the information (however
imposed).

(6)Nothing in this section authorises a disclosure of patient information without
the consent of the individual to whom that information relates.

(7)5Nothing in this section authorises a disclosure of information which—

(a)contravenes the data protection legislation (but in determining whether
a disclosure would do so, take into account the powers conferred by
this section), or

(b)is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the
10Investigatory Powers Act 2016.

(8)This section does not limit the circumstances in which information may be
disclosed under any other enactment or rule of law.

(9)In this section—

  • “commercially sensitive information” means commercial information
    15whose disclosure the relevant authority thinks might significantly
    harm the legitimate business interests of the undertaking to which it
    relates;

  • “data protection legislation” has the meaning given by section 3(9) of the
    Data Protection Act 2018;

  • 20“patient information” means information (however recorded) which—

    (a)

    relates to—

    (i)

    the physical or mental health or condition of an
    individual,

    (ii)

    the diagnosis of an individual’s condition, or

    (iii)

    25an individual’s care or treatment,

    or is (to any extent) derived directly or indirectly from
    information relating to any of those matters, and

    (b)

    identifies the individual or enables the individual to be
    identified (whether by itself or in combination with other
    30information);

  • “relevant authority” means—

    (a)

    the Secretary of State, or

    (b)

    the Department of Health in Northern Ireland;

  • “relevant person” means—

    (a)

    35the government of a country or territory outside the United
    Kingdom;

    (b)

    a person who exercises functions on behalf of such a
    government;

    (c)

    any other person who exercises functions or provides services
    40relating to human medicines in a country or territory outside
    the United Kingdom;

    (d)

    an international organisation that exercises functions or
    provides services relating to human medicines.

9 Requirement for draft consolidated legislation: human medicines

45The Secretary of State must, within the period of three years beginning with the
day on which this Act is passed, publish draft legislation consolidating the
regulatory regime as it applies to human medicines.

Medicines and Medical Devices BillPage 7

Chapter 3 Interpretation

10 Interpretation of Part 2

In this Part—

  • 5“active substance” has the meaning given by regulation 8 of the Human
    Medicines Regulations 2012 (S.I. 2012/1916);

  • “appropriate authority” has the meaning given by section 2(7);

  • “clinical trial” has the meaning given by regulation 2(1) of the Medicines
    for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031);

  • 10EU Clinical Trials Regulation” has the meaning given by section 5(2);

  • “falsified human medicine” means a falsified medicinal product within
    the meaning given by regulation 8 of the Human Medicines
    Regulations 2012;

  • “human medicine” means a medicinal product within the meaning given
    15by regulation 2 of the Human Medicines Regulations 2012;

  • “human medicines provision” has the meaning given by section 6(4);

  • “law relating to human medicines” means—

    (a)

    sections 10 and 15, and Part 4, and section 131 of the Medicines
    Act 1968 (which make provision relating to pharmacies),

    (b)

    20the Human Medicines Regulations 2012,

    (c)

    the Medicines for Human Use (Clinical Trials) Regulations
    2004, and

    (d)

    the Medicines (Products for Human Use) (Fees) Regulations
    2016 (S.I. 2016/190);

  • 25“manufacture” includes assembly;

  • “marketing authorisation” means an authorisation to market a human
    medicine in the United Kingdom;

  • “pharmacy business” means a business (other than a professional practice
    carried on by a doctor or dentist) which consists of or includes the sale
    30of medicinal products that are not subject to general sale;

  • “supplying” includes administering within the meaning given by
    regulation 8 of the Human Medicines Regulations 2012 (and related
    expressions are to be read accordingly).

Part 3 35Veterinary medicines

Chapter 1 Regulations

11 Power to make regulations about veterinary medicines

(1)The appropriate authority may by regulations make provision specified in
40sections 12 and 13 amending or supplementing the Veterinary Medicines

Medicines and Medical Devices BillPage 8

Regulations 2013 (S.I. 2013/2033) for a period of three years beginning with the
day on which this Act is passed.

(2)Regulations made under subsection (1) that introduce significant new policy or
significant changes to existing policy are subject, in relation to regulations
5made by the Secretary of State, to the super-affirmative procedure set out in
section 51, in relation to regulations made by a Northern Ireland department,
to section 52, and, in relation to regulations of the Secretary of State and a
Northern Ireland department acting jointly, to both.

(3)In making regulations under subsection (1), the appropriate authority’s
10overarching objective must be to promote one or more of the following—

(a)the health and welfare of animals;

(b)the health and safety of the public;

(c)the protection of the environment.

(4)In considering whether regulations under subsection (1) would contribute to
15this objective, the appropriate authority must have regard to—

(a)the safety of veterinary medicines;

(b)the availability of veterinary medicines;

(c)the likelihood of the relevant part of the United Kingdom being seen as
a favourable place in which to—

(i)20develop veterinary medicines, or

(ii)manufacture or supply veterinary medicines.

(5)Where regulations under subsection (1) may have an impact on the safety of
veterinary medicines, the appropriate authority may make the regulations
only if the authority considers that the benefits of doing so outweigh the risks.

(6)25In subsection (4)(c), “relevant part of the United Kingdom” means—

(a)so far as the regulations relate to England and Wales and Scotland,
those parts of the United Kingdom, and

(b)so far as the regulations relate to Northern Ireland, that part of the
United Kingdom.

(7)30In this Part, “appropriate authority” means—

(a)in relation to England and Wales and Scotland, the Secretary of State,
and

(b)in relation to Northern Ireland—

(i)the Department of Agriculture, Environment and Rural Affairs
35in Northern Ireland, or

(ii)the Department of Agriculture, Environment and Rural Affairs
in Northern Ireland and the Secretary of State acting jointly.

12 Manufacture, marketing, supply and field trials

(1)Regulations under section 11(1) may make provision about—

(a)40authorisations to manufacture veterinary medicines,

(b)authorisations to import veterinary medicines,

(c)authorisations to distribute veterinary medicines by way of wholesale
dealing,

(d)marketing authorisations,

(e)45marketing, importing or distributing active substances,

(f)the categories of person who may supply veterinary medicines,

Medicines and Medical Devices BillPage 9

(g)requirements that must be met in relation to the supply of veterinary
medicines,

(h)the registration of persons who supply or offer to supply veterinary
medicines by means of the internet,

(i)5the circumstances in which veterinary medicines may be administered,

(j)notification and reporting requirements in relation to veterinary
medicines (or things purporting to be veterinary medicines) that have
been placed on the market,

(k)the labelling and packaging of veterinary medicines or the information
10that must be supplied with them or made available in relation to them,

(l)advertising with regard to veterinary medicines, or

(m)animal test certificates granted under the Veterinary Medicines
Regulations 2013 (S.I. 2013/2033) for research purposes.

(2)Regulations under section 11(1) may make provision corresponding or similar
15to provision in the following EU Regulations—

(a)Regulation (EU) 2019/4 of the European Parliament and of the Council
of 11 December 2018 on the manufacture, placing on the market and
use of medicated feed, amending Regulation (EC) No 183/2005 of the
European Parliament and of the Council and repealing Council
20Directive 90/167/EEC;

(b)Regulation (EU) 2019/6 of the European Parliament and of the Council
of 11 December 2018 on veterinary medicinal products and repealing
Directive 2001/82/EC.

13 Fees, offences, powers of inspectors, costs

(1)25Regulations under section 11(1) may make provision—

(a)about the charging of fees in connection with the exercise of a function
conferred by a veterinary medicines provision,

(b)creating a criminal offence of failing to comply with a provision made
in the regulations,

(c)30applying powers of entry or other powers of an inspector in the
Veterinary Medicines Regulations 2013 (S.I. 2013/2033) with or
without modification in relation to a prohibition or requirement in
provision made in regulations under section 11(1), or

(d)about the recovery of costs incurred in the administration of
35improvement notices or seizure notices under the Veterinary
Medicines Regulations 2013 (see regulations 38 and 41).

(2)Regulations under section 11(1) may not provide for an offence to be
punishable with a sentence of imprisonment of more than two years.

(3)Regulations applying powers of entry in reliance on subsection (1)(c) may not
40confer a power of entry in respect of premises used wholly or mainly as a
private dwelling unless those premises, or any part of them, are approved,
registered or authorised for the sale or supply of veterinary medicines under a
veterinary medicines provision.

(4)In this section, “veterinary medicines provision” means a provision in—

(a)45regulations under section 11(1), or

(b)the Veterinary Medicines Regulations 2013.