Medicines and Medical Devices Bill (HC Bill 90)
A
BILL
TO
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 Human medicines
1 Power to make regulations about human medicines
(1)
The appropriate authority may by regulations make provision specified in sections 2 to
56 amending or supplementing the law relating to human medicines.
(2)
In making regulations under subsection (1), the appropriate authority must
have regard to—
(a) the safety of human medicines;
(b) the availability of human medicines;
(c)
10the attractiveness of the relevant part of the United Kingdom as a place
in which to conduct clinical trials or supply human medicines.
(3) In subsection (2)(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)
15so far as the regulations relate to Northern Ireland, that part of the
United Kingdom.
(4) In this Part, “appropriate authority” means—
(a)
in relation to England and Wales and Scotland, the Secretary of State,
and
(b) 20in relation to Northern Ireland—
Medicines and Medical Devices BillPage 2
(i) the Department of Health in Northern Ireland, or
(ii)
the Department of Health in Northern Ireland and the Secretary
of State acting jointly.
2 Manufacture, marketing and supply
(1) 5Regulations under section 1(1) may make provision about—
(a) authorisations to manufacture human medicines,
(b) authorisations to import human medicines,
(c)
authorisations to distribute human medicines by way of wholesale
dealing,
(d) 10marketing authorisations,
(e) manufacturing, importing or distributing active substances,
(f) brokering in relation to human medicines,
(g) the registration of the premises of pharmacy businesses,
(h) the recording of information about the supply of human medicines,
(i)
15notification 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
that must be supplied with them or made available in relation to them,
(k) advertising with regard to human medicines,
(l)
20the 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, or
(n) prohibitions in the provisions mentioned in subsection (2).
(2)
Subsection (1)(n) refers to the following provisions in the Human Medicines
25Regulations 2012 (S.I. 2012/1916S.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).
3 Falsified medicines
(1) Regulations under section 1(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—
Medicines and Medical Devices BillPage 3
(i) carry unique identifiers associated with the products, and
(ii) are protected with anti-tamper devices,
(b)
for checks to be carried out in relation to packs that have or should have
such a unique identifier,
(c)
5about the infrastructure, systems and processes required for the
allocation and checking of unique identifiers, including provision
about—
(i) who is to set up the infrastructure, systems and processes,
(ii) who is to maintain them, and
(iii) 10who is to pay for them.
(3)
In making regulations in reliance on subsection (1), the appropriate authority
must have regard to the importance of ensuring that information is retained
securely.
4 Clinical trials
(1) 15Regulations under section 1(1) may make provision—
(a)
corresponding or similar to provision in the EU Clinical Trials
Regulation,
(b)
about authorisations concerning clinical trials in the United Kingdom,
including applications for an assessment of the ethics of a proposed
20clinical trial,
(c)
about notification and reporting requirements in relation to clinical
trials,
(d)
about requirements that must be met before a clinical trial may be
carried out, or
(e) 25relating to the conduct of clinical trials.
(2)
In subsection (1)(a), “EU Clinical Trials Regulation” means Regulation (EU) No
536/2014 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.
5 30Fees, offences, powers of inspectors
(1) Regulations under section 1(1) may make provision—
(a)
about 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
35in the regulations, but not one punishable with a sentence of
imprisonment of more than two years, or
(c)
applying relevant powers of entry or other powers of inspectors with
or without modification in relation to a prohibition or requirement in
provision made in the regulations.
(2)
40In subsection (1), “relevant powers of entry or other powers of inspectors”
means 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) 45Part 16 of the Human Medicines Regulations 2012 (S.I. 2012/1916S.I. 2012/1916).
Medicines and Medical Devices BillPage 4
(3) In this Part, “human medicines provision” means a provision in—
(a) regulations under section 1(1),
(b) the Human Medicines Regulations 2012, or
(c) the Medicines for Human Use (Clinical Trials) Regulations 2004.
6 5Emergencies
(1)
Regulations under section 1(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
10disapplication to be subject to—
(a) conditions 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
15regulations must provide—
(a)
that 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.
7 20Interpretation of Part 1
In this Part—
-
“active substance” has the meaning given by regulation 8 of the Human
Medicines Regulations 2012 (S.I. 2012/1916S.I. 2012/1916); -
“appropriate authority” has the meaning given by section 1(4);
-
25“clinical trial” has the meaning given by regulation 2(1) of the Medicines
for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031S.I. 2004/1031); -
“EU Clinical Trials Regulation” has the meaning given by section 4(2);
-
“falsified human medicine” means a falsified medicinal product within
the meaning given by regulation 8 of the Human Medicines
30Regulations 2012; -
“human medicine” means a medicinal product within the meaning given
by regulation 2 of the Human Medicines Regulations 2012; -
“human medicines provision” has the meaning given by section 5(3);
-
“law relating to human medicines” means—
(a)35sections 10 and 15, and Part 4, and section 131 of the Medicines
Act 1968 (which make provision relating to pharmacies),(b)the Human Medicines Regulations 2012,
(c)the Medicines for Human Use (Clinical Trials) Regulations
2004, and(d)40the Medicines (Products for Human Use) (Fees) Regulations
2016 (S.I. 2016/190S.I. 2016/190); -
“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
of medicinal products that are not subject to general sale; -
“supplying” includes administering within the meaning given by
5regulation 8 of the Human Medicines Regulations 2012 (and related
expressions are to be read accordingly).
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Part 2 Veterinary medicines
8 Power to make regulations about veterinary medicines
(1)
10The appropriate authority may by regulations make provision specified in sections 9
and 10 amending or supplementing the Veterinary Medicines Regulations 2013 (S.I.
2013/2033).
(2)
In making regulations under subsection (1), the appropriate authority must
have regard to—
(a)
15the safety of veterinary medicines in relation to animals, humans and
the environment;
(b) the availability of veterinary medicines;
(c)
the attractiveness of the relevant part of the United Kingdom as a place
in which to develop or supply veterinary medicines.
(3) 20In subsection (2)(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.
(4) 25In 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
30in Northern Ireland, or
(ii)
the Department of Agriculture, Environment and Rural Affairs
in Northern Ireland and the Secretary of State acting jointly.
9 Manufacture, marketing, supply and field trials
(1) Regulations under section 8(1) may make provision about—
(a) 35authorisations 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) 40marketing, importing or distributing active substances,
(f) the categories of person who may supply veterinary medicines,
(g)
requirements that must be met in relation to the supply of veterinary
medicines,
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(h)
the registration of persons who supply or offer to supply veterinary
medicines by means of the internet,
(i) the circumstances in which veterinary medicines may be administered,
(j)
notification and reporting requirements in relation to veterinary
5medicines (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
that must be supplied with them or made available in relation to them,
(l) advertising with regard to veterinary medicines, or
(m)
10animal test certificates granted under the Veterinary Medicines
Regulations 2013 (S.I. 2013/2033S.I. 2013/2033) for research purposes.
(2)
Regulations under section 8(1) may make provision corresponding or similar
to provision in the following EU Regulations—
(a)
Regulation (EU) 2019/4 of the European Parliament and of the Council
15of 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
Directive 90/167/EEC;
(b)
Regulation (EU) 2019/6 of the European Parliament and of the Council
20of 11 December 2018 on veterinary medicinal products and repealing
Directive 2001/82/EC.
10 Fees, offences, powers of inspectors, costs
(1) Regulations under section 8(1) may make provision—
(a)
about the charging of fees in connection with the exercise of a function
25conferred by a veterinary medicines provision,
(b)
creating a criminal offence of failing to comply with a provision made
in the regulations, but not one punishable with a sentence of
imprisonment of more than two years,
(c)
applying powers of entry or other powers of an inspector in the
30Veterinary Medicines Regulations 2013 (S.I. 2013/2033S.I. 2013/2033) with or
without modification in relation to a prohibition or requirement in
provision made in regulations under section 8(1), or
(d)
about the recovery of costs incurred in the administration of
improvement notices or seizure notices under the Veterinary
35Medicines Regulations 2013 (see regulations 38 and 41).
(2)
Regulations applying powers of entry in reliance on subsection (1)(c) may not
confer 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
40veterinary medicines provision.
(3) In this section, “veterinary medicines provision” means a provision in—
(a) regulations under section 8(1), or
(b) the Veterinary Medicines Regulations 2013.
11 Interpretation of Part 2 and supplementary provision
(1) 45In this Part—
-
“active substance” means any substance or mixture of substances
intended to be used in the manufacture of a veterinary medicine that,
when used in its production, becomes an active ingredient of that
medicine; -
5“appropriate authority” has the meaning given by section 8(4);
-
“manufacture” includes assembly;
-
“marketing authorisation” means an authorisation to market a veterinary
medicine in the United Kingdom; -
“veterinary medicine” means a veterinary medicinal product within the
10meaning given by regulation 2 of the Veterinary Medicines Regulations
2013 (S.I. 2013/2033S.I. 2013/2033).
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(2)
In the Animals (Scientific Procedures) Act 1986, in section 2 (regulated
procedures), in subsection (8)(d), after “the Veterinary Medicines Regulations
2011” insert “or the Veterinary Medicines Regulations 2013”.
15Part 3 Medical devices
CHAPTER 1 Regulations
12 Power to make regulations about medical devices
(1)
The Secretary of State may by regulations make provision specified in sections 13 to 15
20amending or supplementing the Medical Devices Regulations 2002 (S.I. 2002/618S.I. 2002/618).
(2)
In making regulations under subsection (1), the Secretary of State must have
regard to—
(a) the safety of medical devices;
(b) the availability of medical devices;
(c)
25the attractiveness of the United Kingdom as a place in which to develop
or supply medical devices.
13 Manufacture, marketing and supply
(1) Regulations under section 12(1) may make provision about—
(a)
requirements that must be met in relation to medical devices in order
30for them to be marketed, put into service or otherwise supplied
(“relevant requirements”), including—
(i)
requirements in terms of design, manufacture, composition or
other characteristics of the devices, or
(ii)
requirements imposed on persons involved in marketing or
35supplying the devices,
(b)
assessments of whether relevant requirements are met in relation to
medical devices,
(c)
who may carry out such assessments, including provision about the
appointment of one or more persons (whether or not established in the
40United Kingdom) who meet criteria set out in the regulations—
(i) to assess whether relevant requirements are met, and
(ii) if appropriate, to confirm that they are,
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(d)
treating confirmation that relevant requirements are met given by one
or more persons who are not appointed under provision made in
reliance on paragraph (c) in the same way as confirmation given by a
person who is so appointed,
(e)
5the making of declarations confirming that relevant requirements are
met,
(f)
requirements that medical devices carry evidence that relevant
requirements are met, including evidence that confirmation has been
given as mentioned in paragraph (c) or (d),
(g)
10the packaging of medical devices, and information, labelling or
instructions to be supplied on, with or in relation to them,
(h)
one or more registers of medical devices, their manufacturers or their
suppliers, including provision—
(i)
conferring functions relating to establishing and maintaining a
15register,
(ii)
requiring information in relation to a medical device to be
entered in a register, and
(iii)
permitting or requiring some or all of the information entered
in a register to be made publicly available,
(i)
20investigations into or evaluations of the safety or performance,
including the clinical effectiveness, of medical devices, or
(j) surveillance of the market in medical devices.
(2)
Provision made in reliance on subsection (1)(a) may (among other things)
identify relevant requirements by reference to international agreements or
25standards relating to the marketing or supply of medical devices, including
agreements or standards as they have effect from time to time.
14 Fees, information, offences
(1) Regulations under section 12(1) may make provision—
(a)
about the charging of fees in connection with the exercise of a function
30conferred by a medical devices provision, including the charging of
fees by a person appointed under provision made in reliance on section
13(1)(c),
(b)
about the recording of information regarding the safety and efficacy of
medical devices, including the extent to which relevant requirements
35that apply in relation to the devices are met,
(c)
permitting or requiring such information to be disclosed to the
Secretary of State or to a person appointed under provision made in
reliance on section 13(1)(c), or
(d)
amending the Schedule to the Medical Devices Regulations 2002 (S.I.
402002/618) inserted by Schedule 2 to this Act (list of regulations breach
of which is an offence under regulation 60A).
(2) In this Part, “medical devices provision” means a provision in—
(a) regulations under section 12(1), or
(b) the Medical Devices Regulations 2002.
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15 Emergencies
(1)
Regulations under section 12(1) may make provision about the disapplication
of a medical devices provision in circumstances which give rise to a need to
protect the public from a risk of serious harm to health.
(2)
5Regulations made in reliance on subsection (1) may provide for the
disapplication to be subject to—
(a) conditions set out in the regulations;
(b) conditions set out in a protocol published by the Secretary of State.
(3)
Where regulations made in reliance on subsection (1) provide that the
10Secretary of State may publish a protocol setting out conditions, the
regulations must provide—
(a) that the Secretary of State 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 15Enforcement
Enforcement notices
16 Compliance notices
(1)
This section applies where the enforcement authority has reasonable grounds
to suspect that a person involved in marketing or supplying a medical device
20is not complying with a medical devices provision.
(2)
The enforcement authority may serve a notice (“a compliance notice”) on the
person—
(a)
identifying the medical devices provision with which the person is
suspected not to be complying,
(b)
25setting out the enforcement authority’s grounds for suspecting that the
person is not complying with the provision,
(c)
requiring the person to comply with the provision within a specified
period,
(d)
requiring the person within a specified period to provide evidence to
30the satisfaction of the enforcement authority that the person is
complying with the provision, and
(e)
requiring the person within a specified period to take any other
measures that may be specified in order to comply with the provision.
(3)
A period specified in reliance on subsection (2)(c), (d) or (e) must be a period
35of at least 28 days beginning with the day on which the notice is served.
(4) The enforcement authority may vary or revoke a compliance notice.
(5)
Where the person mentioned in subsection (1) is a manufacturer, a notice
under subsection (2) may be served on the manufacturer or on another person
who has been designated by the manufacturer to act as the manufacturer’s
40representative (or both).
(6) In this section, “specified” means specified in the compliance notice.