Citation, commencement and interpretation

1.-(1) These Regulations may be cited as the Motor Vehicles (Driving Licences) (Amendment) Regulations 2011 and come into force on 15th November 2011.

(2) In these Regulations, "the principal Regulations" means the Motor Vehicles (Driving Licences) Regulations 1999(2).

Amendment to disabilities prescribed in respect of Group 1 licences

2.-(1) Regulation 72 of the principal Regulations is amended as follows.

(2) After paragraph (3) there is inserted-

"(4) Diabetes mellitus is prescribed for the purposes of section 92(2) of the Traffic Act as a relevant disability in relation to an applicant for, or a holder of, a Group 1 licence, who is being treated with insulin or another medication which carries a risk of inducing hypoglycaemia and-

(a)has experienced two or more episodes of severe hypoglycaemia during the previous one year period; or

(b)has impaired awareness of hypoglycaemia.

(5) Diabetes mellitus is prescribed for the purposes of section 92(4)(b) of the Traffic Act in relation to an applicant for a Group 1 licence who is being treated with insulin and-

(a)has had no more than one episode of severe hypoglycaemia during the period of one year immediately preceding the date when the licence is granted;

(b)does not have impaired awareness of hypoglycaemia; and

(c)satisfies the conditions prescribed in paragraph (6).

(6) The conditions are that the applicant-

(a)can demonstrate an understanding of the risks of hypoglycaemia and adequate control of the condition;

(b)undertakes appropriate blood glucose monitoring;

(c)is under regular medical review; and

(d)is a person in respect of whom the Secretary of State is satisfied that the driving of a vehicle in accordance with the licence is not likely to be a source of danger to the public.

(7) In this regulation-

"impaired awareness of hypoglycaemia" means the inability to detect the onset of hypoglycaemia because of a total absence of warning symptoms;

"severe hypoglycaemia" means an episode of hypoglycaemia requiring the assistance of another person".

Amendment to disabilities prescribed in respect of Group 2 licences

3.-(1) Regulation 73 of the principal Regulations is amended as follows.

(2) For paragraph (6) there is substituted-

"(6) Diabetes mellitus is prescribed for the purposes of section 92(2) of the Traffic Act as a relevant disability in relation to an applicant for, or a holder of, a Group 2 licence who is being treated with insulin or another medication which carries a risk of inducing hypoglycaemia and-

(a)has experienced one or more episodes of severe hypoglycaemia during the previous one year period; or

(b)does not have full awareness of hypoglycaemia.

(6A) Diabetes mellitus is prescribed for the purposes of section 92(4)(b) of the Traffic Act in relation to an applicant for a Group 2 licence, who-

(a)is being treated with insulin and-

(i)has undergone treatment with insulin for at least 4 weeks;

(ii)has full awareness of hypoglycaemia;

(iii)has not, during the period of one year immediately preceding the date when the licence is granted, had an episode of severe hypoglycaemia; and

(iv)satisfies the conditions prescribed in paragraphs (6B) and (6C); or

(b)is being treated with a medication which carries a risk of inducing hypoglycaemia, other than insulin, and-

(i)has full awareness of hypoglycaemia;

(ii)has not, during the period of one year immediately preceding the date when the licence is granted, had an episode of severe hypoglycaemia; and

(iii)satisfies the conditions prescribed in paragraphs (6B) and (6D).

(6B) The conditions are that the applicant-

(a)regularly monitors his or her condition and, in particular, undertakes blood glucose monitoring at least twice daily and at times relevant to driving;

(b)provides a signed declaration to the Secretary of State that he or she-

(i)understands the risk of hypoglycaemia and will comply with such directions regarding treatment for diabetes as may from time to time be given by the registered medical practitioner overseeing that treatment, or one of the clinical team working under the supervision of that registered medical practitioner;

(ii)will immediately report to the Secretary of State in writing any significant change in his or her condition and pending any enquiries being made by the Secretary of State, will follow the advice of his or her registered medical practitioner, or one of the clinical team working under the supervision of that registered medical practitioner, concerning fitness to drive; and

(iii)will provide such evidence as the Secretary of State may request to demonstrate that the monitoring referred to in sub-paragraph (a) is being carried out;

(c)is a person in respect of whom the Secretary of State is satisfied that the driving of a vehicle in accordance with the licence is not likely to be a source of danger to the public.

(6C) The further conditions for an applicant who is being treated with insulin are that-

(a)the applicant has attended an examination by a hospital consultant specialising in the treatment of diabetes, who has provided a report sufficient to satisfy the Secretary of State that the applicant has a history of responsible diabetic control and currently has a minimal risk of impairment due to hypoglycaemia;

(b)the applicant monitors his or her condition as set out in paragraph (6B)(a), using a device that incorporates an electronic memory function to measure and record blood glucose levels, and undertakes to continue so to monitor.

(6D) The further condition for an applicant who is not being treated with insulin is that-

• the applicant has attended an examination by a registered medical practitioner, who has provided a report sufficient to satisfy the Secretary of State that the applicant has a history of responsible diabetic control and currently has a minimal risk of impairment due to hypoglycaemia.

(6E) In this regulation "severe hypoglycaemia" has the same meaning as in regulation 72(7).".

(3) Paragraph (9)(3) is omitted.

(4) Paragraph (10)(4) is omitted.

Duty to review

4.-(1) The Secretary of State must from time to time-

(a)carry out a review of regulations 2 and 3;

(b)set out the conclusions of the review in a report, and

(c)publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how Commission Directive 2009/112/EC and Commission Directive 2009/113/EC(5) (which are implemented by means of regulations 2 and 3) are implemented in other member States.

(3) The report must in particular-

(a)set out the objectives intended to be achieved by the regulatory system established by those regulations,

(b)assess the extent to which those objectives are achieved, and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(4) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations implement the minimum standards of medical fitness required for diabetes mellitus ("diabetes"), as specified in Directive 2009/112/EC of 25 August 2009 and Directive 2009/113/EC of 25 August 2009 ("the Medical Directives") (O.J. No. L 223, 26.8.09, p.26 and p.31) which amend respectively Directive 91/439/EEC of the European Parliament and of the Council on driving licences (O.J. No. L 237, 24.8.91, p.1) and Directive 2006/126 EC of the European Parliament and of the Council on driving licences (O.J. No. L 51, 22.2.06, p.17). The Medical Directives were added to Annex XIII of the European Economic Area Agreement by Decision of the EEA Joint Committee No. 28/2010 of 12 March 2010 (O.J. No. L 143, 10.6.10, p.23).

These Regulations amend the medical standards applicable for driver licensing of applicants and licence holders with diabetes, by making amendments to the Motor Vehicles (Driving Licences Regulations 1999 ("the principal Regulations"). They amend the terms in which diabetes is prescribed as a relevant disability for the purposes of section 92(2) of the Road Traffic Act 1988, with the effect that a person with that relevant disability cannot be granted a licence; and for the purposes of section 92(4)(b) of that Act, by which an applicant can be granted a licence for certain prescribed formulations of a disability on prescribed conditions.

Regulation 2 of these Regulations amends regulation 72 of the principal Regulations, in respect of Group 1 licences. Diabetes that is being treated with medication which carries a risk of inducing hypoglycaemia is a prescribed disability for a person who has had two or more episodes of severe hypoglycaemia during the previous one year period, or who has impaired awareness of hypoglycaemia (reg 72(4)). An applicant for a licence who has diabetes treated with insulin is not barred by that disability from obtaining a licence if he or she does not have impaired awareness of hypoglycaemia, has been without more than one severe hypoglycaemic attack for a year and meets other conditions concerning diabetes (reg. 72(5) to (7)). "Impaired awareness of hypoglycaemia" is defined in regulation 72(7) as the inability to detect the onset of hypoglycaemia because of a total absence of warning symptoms.

Regulation 3 of these Regulations amends regulation 73 of the principal Regulations, in relation to Group 2 licences. Diabetes that is being treated with medication which carries a risk of inducing hypoglycaemia is a prescribed disability for a person where there have been one or more episodes of severe hypoglycaemia during the previous one year period, or where there is not full awareness of hypoglycaemia (reg 73(6)). Applicants for a licence who have diabetes, which has been treated with insulin for over 4 weeks, are not prevented by the disability from obtaining a licence if there is full awareness of hypoglycaemia, there has been no severe hypoglycaemic attack for a year, and the other conditions concerning diabetes are met (reg. 73(6A),(6B) and (6C)). Applicants on any other medication carrying a risk of inducing hypoglycaemia, who likewise have full awareness of hypoglycaemia and have been without a severe hypoglycaemic attack for a year, will also not be prevented from obtaining a licence if prescribed conditions are met (reg. 73(6A), (6B) and (6D).

Prior to amendment by these Regulations, regulation 73(6) of the principal Regulations prescribed insulin treated diabetes as a prescribed disability for Group 2 driving, but permitted an exception for persons with diabetes requiring insulin treatment who held an "obsolete vocational licence" on 1st April 1991, where the traffic commissioner who granted the last obsolete vocational licence knew of the disability before 1st January 1991. That exception has been removed: all drivers with insulin treated diabetes can now be considered for any category of Group 2 licence, by virtue of new paragraphs (6A), (6B) and (6C) of regulation 73.

Regulation 4 requires the Secretary of State to review the operation and effect of these Regulations and publish a report within five years after they come into force and within every five years after that. Following a review it will fall to the Secretary of State to consider whether the Regulations should remain as they are, or be revoked or be amended. A further instrument would be needed to revoke the Regulations or to amend them.

A transposition note setting out how the Medical Directives have been transposed into the law in England and Wales and Scotland has been produced and is available on the Department for Transport website, www.dft.gov.uk.

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from www.direct.gov.uk.

The Explanatory Memorandum, to which is attached the transposition note and impact assessment, is available alongside the instrument at www.legislation.gov.uk.