Pharmacy Order 2010

My Lords, I start by recognising the distinguished work and record of the Royal Pharmaceutical Society of Great Britain, which I omitted to mention in my opening remarks. I should like to rectify that and say how grateful we are for the wonderful work that it has done over a very long period. I intend first to deal with the issue of the rights of entry, which have been raised by several noble Lords. I also read with interest the note that the royal society sent to the noble and learned Lord, Lord Scott. I also note that in the process of preparing for this I failed to find anything in the Merits Committee’s report on this issue to suggest that this was a key issue of concern for it in its examination of the order. I know from the words of the noble and learned Lord, Lord Mayhew, and the noble Lords, Lord Selsdon, Lord Marlesford and Lord Elton, that this is a broader issue that needs to be discussed across the piece. Therefore, it is unlikely that I shall be able to satisfy them tonight. However, I note that this is a campaign to which we will return. The noble and learned Lord, Lord Scott, has explained to me in writing and in person his broader concerns about this matter, for which I am grateful. Why does the inspectorate need the power to enter an individual’s private dwelling without obtaining a warrant? I shall read through my brief to get this into the record. It may not satisfy noble Lords, but I need to say these things and will then seek to answer some of the specific points raised. These powers are needed because of the different business models which may operate from registered pharmacy premises. Examples include an application to register the bedroom of a private flat as an internet pharmacy or registered pharmacies that operate from the ground floor of private dwellings with the upper floors or outside storage areas designated as living space. Inspectors have to ensure compliance with standards for storage of medicines that may be in those areas designated as private dwelling space. Access to storage areas may also cross into private dwellings via hallways, stairs and so on. The noble Baroness, Lady Barker, outlined the issues well in her remarks. Article 10(2) of the order provides that an inspector should give 24 hours’ notice of the intended entry into premises that are, or form part of, a private dwelling house. This is not intended to give an inspector a power to enter such premises without consent or by force. Article 10(3) covers the position when entry has been refused, in which case an inspector must apply for a warrant. The possibility of refusal of entry without a warrant is specifically catered for in Article 10, which provides alternative measures that the inspector will be required to employ in order to exercise their functions. This involves obtaining a warrant. This country has a very good reputation for preventing the unlawful supply of medicines and preventing counterfeit medicines from entering the supply chain. This is a credit to the work of inspectors like those of the pharmacy regulator and those of the Medicines and Healthcare products Regulatory Agency. The same powers authorise the inspectors of the Veterinary Medicines Directorate, who inspect businesses such as saddlers and merchants who supply riding saddles and tack as well as veterinary medicines. Many of these businesses operate from farms where the shop and stores form part of the private dwelling. In the vast majority of cases, registrants are compliant with requests to enter premises without recourse to the formal powers. However, there are some cases where these powers are needed and must therefore be provided for. This is therefore a transfer of powers, not an addition. In our view, it is not an issue of principle but an issue of transferring powers. The noble Lord, Lord Selsdon, startled me for a moment, I confess, when he asked me personally what my powers of entry were. Sorry to be flippant, but I was thinking, "Have I got my keys with me for tonight?". I will have to write to him about the department’s powers of entry specifically, and I undertake to do that. I say to the noble Lord, Lord Marlesford, that I do not regard this as wasting Parliament’s time; it is an important issue, and I am certainly very happy to discuss it. The noble and learned Lord, Lord Mayhew, raised the issue of whether the order allows any rule to be made. The answer is no, the rules must be subject to consultation and laid before Parliament and the Scottish Parliament for negative resolution after approval by the Privy Council. The noble Lord, Lord Marlesford, asked whether the department consulted the Home Office. No, we did not consult the Home Office; we consulted the Ministry of Justice and it was content. The noble and learned Lord, Lord Scott, was questioning the Medicines Act 1968 provisions of entry and inspection. That Act is also the vehicle that provides the entry and inspection powers of the Medicines and Healthcare products Regulatory Agency, so they protect the medicine supply chain in this country. The noble and learned Lord also asked about warrants and inspectors’ powers and why the inspectorate cannot obtain a warrant after being refused access rather than having the power to gain access in the first place. Article 10(2) of the order provides that an inspector should give 24 hours’ notice of the intended entry to any premises that are or form part of a private dwelling house. This is not intended to give an inspector the power to enter such premises without consent or by force. Article 10(3) covers the position where entry has been refused in which the inspector must apply for a warrant, and I think that I have already explained that to the noble and learned Lord. I think that my remarks so far also cover most of the points that the noble Earl, Lord Howe, raised about powers of entry.