UK - Paraphernalia and the Law - Interesting information about paraphernalia for injection

[Dickon]

I found this here: http://www.exchangesupplies.org/drug_information/articles/paraphernalia_and_the_law.html . The site belongs to a company called Exchange Supplies, which seems to do exactly what it says on the tin. I thought this was interesting from a legal perspective.


Paraphernalia and the law

Paraphernalia supply has been a problematic legal issue in the UK since the inception of needle exchange. This page charts the history of the impact of the law on drug users, and how, why and when the law has changed.
The two main legal issues have been around:

• A. The Misuse of Drugs Act 1971 has a subsection 'section 9a' which, at the time made it an offence for a person to supply any article - except a syringe or needle - in cases where 'the supplier believes it may be used by the recipient to administer an unlawful drug or prepare an unlawful drug for administration'; and

• B. the Medicines Act, because under the Medicines Act water for injections was a prescription only medicine. This meant that, in practice, it couldn't be legally supplied by needle exchanges.

Section 9a was drafted to enable prosecution of drug dealers who sell complete 'kits' of drug and implements to take them, and/or are raided and although not found to be in possession of drugs, do have all the paraphernalia needed to take them.
However, this obscure bit of law was virtually unknown in the drugs field, and was rarely by the police for it's intended purpose following the failure of a number of high profile cases of attempted prosecutions for sale of cannabis and cocaine consumption implements, in which defendants had used the "it's an ornament" defence.



Changing section 9a of the Misuse of Drugs Act
However, in the late 1990’s the issue of section 9A of the Misuse of Drugs Act with regard to the supply of paraphernalia by needle exchanges also became an issue following a letter to the Pharmaceutical Journal on October 24, 1998 from a pharmacist in Somerset who questioned the legality of supplying citric acid to injecting drug users. In the wake of this, pharmacists up and down the country stopped selling citric to injecting drug users.
While working for the drug service in Dorchester, Andrew Preston negotiated the UK’s first local agreement with Dorset police to enable pharmacists there to resume sales of citric, and other areas were able to use this model to negotiate further local agreements. Glasgow Drug Action Team received an assurance from the procurator fiscal for the Glasgow and Strathkelvin that no action was envisaged against “pharmacists who supplied citric acid, etc, in the interest of harm limitation as part of a recognised needle and syringe exchange scheme.”
The The Law and Ethics Committee of the Royal Pharmaceutical Society recommended that the RPS should make clear to pharmacists in the Glasgow area that it would support their professional decision to supply citric acid in appropriate circumstances.
However, despite these local and professional body successes, the availability of citric and vitC continued to decline. As heroin can’t be injected without an acid, injectors began using lemon juice and vinegar and workers on our safer injecting courses from drug services up and down the UK began reporting eyesight problems and blindness caused by candidal infections from these acids.
We tried to persuade a number of companies in the field to supply citric acid in single-use sachets but they were all too concerned about the legal problems that could arise. So, in the spring of 2001 we set about arranging the manufacture for ourselves.



September 2001: citric sachets launched
The sachets were launched in September 2001, and were supplied by drug services, many of whom used the Dorset agreement as a model for ensuring the supply didn’t put workers at risk of prosecution.
The increasing number of services supplying citric, and the benefits it was having in terms of attracting users into contact with services, and reducing the harm associated with other acidifiers increased the pressure to clear up the anomaly in the law.
Kay Roberts, a pharmacist managing the Greater Glasgow pharmacy needle exchange scheme, and member of he ACMD, put the issue on the agenda of the ACMD technical committee, and in late 2001 the committee recommended that the Misuse of Drugs Act be amended to permit the supply of certain additional items.
In November 2002 the Home Office issued a consultation document requesting responses to the proposal to amend Section 9A. To see the consultation document, and some of the responses to it, click here.

February 2003: vitC sachets made available
In response to demand from drug users, we launched a (technically illegal) single use VitC (ascorbic acid) sachet, alongside our citric sachet.

July 2003: citric, swabs, spoons, and filters made legal
On 8th July 2003 a press release announced that the ACMD recommendations on paraphernalia supply had been accepted, and that 'The Government will be laying a negative resolution statutory instrument to implement changes to section 9A of the Misuse of Drugs Act 1971' with effect from 1/08/03.
This will make legal the supply to drug users of '5 types of items':

• ampoules of water for injection;
• swabs;
• utensils for the preparation of a controlled drug (spoons, bowls, cups, dishes);
• citric acid; and,
• filters.

To see the press release which announced this change, click here
The change didn’t make legal the supply of VitC (ascorbic acid), which remained illegal to supply. However, the tone of the press release, and the fact that it was now clear that the intention of Section 9A was to allow the supply of items that could reduce harm, and many services continued to provide it.



September 2003: launch of sterile water
The change to the misuse of drugs act which removed the prohibition on supply of water for injections made no practical difference to the supply to injecting drug users because, like all injectable preparations, it remained a prescription only medicine.
We therefore tried to find a way around this problem by supplying a single use 1.4ml ampoule of sterile water. Technically illegal under the Misuse of Drugs Act (because it wasn’t ‘water for injections’). The ampoules were available from September 2003 until June 2004.
In June 2004 a complaint to the medicines regulator - the MHRA - by a competitor resulted in all of our stock being quarantined, and an order to stop selling it on the grounds that it was ‘presented as a medicine’ and therefore needed a medicines licence.
We immediately began the process of applying for a licence, and a letter writing campaign was launched to persuade the MHRA to allow the resumption of supply, and to reclassify water for injections as soon as possible.



October 2004: MHRA consult on changing the status of water for injections
This campaign was very effective, and on the 19th October the MHRA consulted on changing the status of water for injections to enable it’s supply by needle exchanges. To see the consultation document, and our response to it, click here.



June 2005: Supply of water for injections made legal!
On the 27/6/2005 the pressure to change the law, and the mass of responses to the consultation paid off. Statutory Instrument 2005 No.1507 The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2005 was published on the HSMO website (to see it, click here)
The SI became law on 30th June 2005 and contained provisions for the supply, by drug workers, of water for injections to injecting drug users (without any pack size restriction, as proposed in the consultation) and with a limit on the size of ampoule that could be supplied of 2ml.
Water for injections is still a prescription only medicine, and a prescription is still required for all uses other than supply to injecting drug users, but this change to the regulations meant that, at last, drug workers could legally dispense water to injecting drug users.
Unfortunately, although this made the supply of water completely legal in terms of both the medicines act and the misuse of drugs act, the only 2ml licensed water for injections available in the UK was in a glass ampoule.
We continued with our application for a licence for our plastic ampoule, but made little progress.

October 2005: vitC made legal
Meanwhile, The Advisory Council on the Misuse of Drugs (ACMD) advised government that the oversight regarding the omission of VitC from the section 9a exclusions should be corrected, and on the 12th October 2005 Under-Secretary of State Paul Goggins signed a statutory instrument - SI 2005 (2846) - adding ascorbic acid (VitC) to the list of items that it is legal for services to supply.



January 2006: glass 2ml ampoule and ‘safe snap’ amp snapper made available
In the autumn of 2005, with our licence application for a plastic ampoule stuck at the MHRA we reviewed all of our options, and looked again at the issue of glass ampoules which are readily available. Having discussed the problem, the idea of developing a device that could completely enclose the ampoule thus removing the risk of glass cuts emerged.
We filed an application for a patent for the ‘safe snap’ ampoule snapper in October 2005 and immediately began the product development and testing. We negotiated a reliable supply from the UK’s biggest supplier of Water for Injections and ordered deliveries of ampoules through January, February and March to ensure continuity of supply.
Manufacture of the safe snap began in early January, and the ampoule and safe snap were launched at the end of the month. Making this the first time a safe, legal supply of water for injections had been available in the UK.
February 2007
Exchange Supplies again push the boundries, and formalise the provision of foil as a reverse transition intervention with the first foil pack designed for drug users.
As foil wasn't on the list of exempt items under section 9a, extensive guidance was again issued on our website to enable services to distribute it wiithout fear of prosecution – in the same way that they have before for citric, vitC, and water. We expect the law to change to allow foil to be provided.. watch this space.