Reports > The Fourth Report > CHAPTER THREE - A Brief History of the Regulation of Controlled Drugs >
The Legislation of 1971 and 1973
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3.42 |
The MDA 1971 and the Regulations made under it in 1973 provided a new statutory framework for the control and regulation of 'dangerous or otherwise harmful' drugs which, from this time, usually became known as 'controlled' drugs. The new legislation came into force in July 1973. The Act remains in force today. It repealed almost all the previous legislation and re-enacted many of its substantive provisions. The Regulations relating to addiction, which had come into force in 1968, were retained. The MDR 1973 were amended on many occasions and were replaced by the MDR 1985, which were in turn amended several times before being replaced by the Regulations currently in force, the MDR 2001. |
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3.43 |
Essentially, the MDA 1971 made it unlawful to possess or supply a controlled drug unless an exception or exemption applied. A number of specific offences were created, such as unlawful possession of a controlled drug and unlawful possession of a controlled drug with intent to supply it to another. A controlled drug was defined as any drug listed in Schedule 2 to the Act. Under Schedule 2, controlled drugs were divided into Classes A, B and C. Upon this classification depended the severity of the penalties that could be imposed under the criminal law for an infringement of the Act. Drugs such as heroin and cocaine were in Class A and the penalty imposed for committing, say, an offence of unlawful possession of heroin was more severe than that which could be imposed for unlawful possession of a drug from Class B or Class C. Class B contained such drugs as amphetamines and cannabis and Class C contained such drugs as benzodiazepines. |
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3.44 |
Section 10 of the Act empowered the Home Secretary to make regulations to prevent the misuse of controlled drugs with particular reference to safe custody, documentation, record keeping, furnishing information, packaging and labelling, transportation, destruction or disposal, prescribing, dispensing, and notification of and prescribing for addicts. Section 18 of the Act made it a criminal offence to breach any of the Regulations made under the Act or the terms of a licence granted under the Act. |
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3.45 |
Section 7 of the MDA 1971 allowed the Home Secretary to authorise activities that would otherwise be unlawful under the Act. It specifically required him to make regulations to 'secure... that it is not unlawful' for a doctor, acting as such, to possess, prescribe, administer or supply controlled drugs or for a pharmacist or person conducting a pharmacy business to supply controlled drugs. Without such regulations, doctors and pharmacists would not be able to deal with controlled drugs in any way. |
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3.46 |
Section 13(2) of the MDA 1971 gave the Home Secretary a new power to prohibit a practitioner from dealing with controlled drugs where s/he had been 'prescribing, administering or supplying ... any controlled drugs in an irresponsible manner'. Section 14 provided for the setting up of a tribunal system by which cases of alleged irresponsible prescribing could be investigated and a recommendation made to the Home Secretary with a view to possible curtailment of a doctor's powers to possess or prescribe controlled drugs. The power of the Home Secretary to withdraw the authority of a doctor who had been convicted of offences under the relevant legislation was preserved by section 12. As I explained in paragraph 3.21, this power had been introduced in the 1921 Regulations. |
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3.47 |
The Act also provided for the setting up of a statutory Advisory Council on the Misuse of Drugs (ACMD) to replace a non-statutory Interdepartmental Advisory Committee on Drug Dependence, which had provided advice since 1968. The main duty of the ACMD was to keep under review the situation in the UK in relation to drugs liable to misuse and to advise on measures to deal with any social problems caused by such misuse. |
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3.48 |
The MDR 1973 provided a code of Regulations governing the conduct of those people who were permitted to possess, prescribe, supply or administer a controlled drug under an exception to or exemption from the main provisions of the Act. The Regulations divided controlled drugs into categories according to the degree to which their use was to be regulated. Somewhat confusingly, instead of utilising the three Classes A, B and C under Schedule 2 to the MDA 1971, the Regulations divided all controlled drugs into four Schedules. Schedule 1 contained drugs that required little regulation. Schedule 2 contained such drugs as heroin and cocaine, which could be held and prescribed by doctors, dentists and veterinary surgeons; they were subject to quite stringent regulation. Schedule 3 contained very few drugs, which, somewhat illogically, were less regulated than those in Schedule 2. Schedule 4 contained the drugs to be most closely regulated. They could be dealt with only by persons specifically licensed to do so by the Home Office. |
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3.49 |
The MDR 1973 contained many provisions, most of which remain in force today, albeit after some amendment and consolidation in the MDR of 1985 and 2001. I shall mention only those of particular interest to the Inquiry. Pharmacists and doctors, acting in their capacity as such, were authorised to possess any controlled drug, save those in Schedule 4, and supply it to anyone who might lawfully possess it. Regulation 6 authorised persons such as police officers, customs officers, post office employees and carriers, acting as such, to be in lawful possession of controlled drugs and to supply them to anyone who might lawfully possess them. Any person lawfully in possession of a controlled drug was authorised to supply it to the person for whom it was obtained. The Regulations laid down formal requirements for prescriptions for controlled drugs, save those in Schedule 1. These included the requirement that the information on the prescription should be written in the prescriber's own hand. A controlled drug prescription was to be valid for only 13 weeks after the date of issue. Any person with authority to supply to another a controlled drug from Schedule 2 or 4 was under a duty to keep a chronological record of all such transactions in a controlled drugs register (CDR). The specifications relating to CDRs were also laid down. Records relating to controlled drugs, such as CDRs, were to be kept for at least two years from the date on which the last entry was made. Regulation 24 provided that controlled drugs from Schedules 2 and 4 could be lawfully destroyed by doctors and pharmacists only in the presence of a person authorised by the Home Secretary and that a record of such destruction should be kept. In practice, Home Office inspectors, CIOs and inspectors appointed by the RPSGB were authorised to witness the destruction of controlled drugs. |
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3.50 |
The Misuse of Drugs (Safe Custody) Regulations 1973, which, with some amendment, remain in force today, prescribe the arrangements for the physical security of controlled drugs held by any person entitled to hold a stock. The requirements apply only to drugs within Schedule 2 (apart from quinalbarbitone and some other liquid preparations), and a few from Schedule 3, to the MDR 2001. The occupiers of pharmacies, nursing homes and private hospitals must, so far as circumstances permit, keep the relevant controlled drugs in a 'locked safe, cabinet or room which is so constructed as to prevent unauthorised access to the drugs'. The Regulations also provide a specification for the type of cabinet in which controlled drugs are to be stored. The duty of a GP who keeps a stock of controlled drugs is provided by regulation 5. Any person keeping a stock of controlled drugs must ensure that, if the drugs are not kept in a locked safe, cabinet or room so constructed as to prevent unauthorised access to the drugs, they are, so far as circumstances permit, kept in a locked receptacle which can be opened only by that person or by someone acting with his/her authority. |
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The Medicines Act 1968
