RPSGB Response MLX 357 supply chain and reducing the

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					                     Royal Pharmaceutical Society
                     of Great Britain
                     Helping pharmacists achieve excellence

Ms Elizabeth Evans                                                               P ROFESSIONAL S ERVICES
Medicines and Healthcare products Regulatory Agency                              DIRECTORATE
                                                                                 Practice Division
Room 16-161 Market Towers
                                                                                 Telephone: 020 77572 2537
1 Nine Elms Lane                                                                 Facsimile: 020 7572 2501
London                                                                           e-mail: sadia.khan@rpsgb.org

9 March 2009

Dear Ms Evans,

Re: MLX 357 – Consultation on measures to strengthen the medicines’ supply chain and
reduce the risk from counterfeit medicines

We write on behalf of the Royal Pharmaceutical Society of Great Britain to respond to the
above consultation document.

The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional and regulatory
body for pharmacists in England, Scotland and Wales. It also regulates pharmacy technicians
on a voluntary basis, which is expected to become statutory under anticipated legislation.

The primary objectives of the Society are to lead, regulate, develop and represent the
profession of pharmacy.

The Society leads and supports the development of the profession within the context of the
public benefit. This includes the advancement of science, practice, education and knowledge
in pharmacy. In addition, it promotes the profession’s policies and views to a range of external
stakeholders in a number of different forums.

                 1 Lambeth High Street, London SE1 7JN
                 Head Office Telephone: 020 7735 9141 Facsimile: 020 7735 7629     www.rpsgb.org.uk
                 Jeremy Holmes MA Chief Executive and Registrar
                 Patron: Her Majesty The Queen
The Society has responsibility for a wide range of functions that combine to assure
competence and fitness to practise. These include controlled entry into the profession,
education, registration, setting and enforcing professional standards, promoting good practice,
providing support for improvement, dealing with poor performance, dealing with misconduct
and removal from the register.

Thank you for consulting the Society.

Yours sincerely,

Sadia Khan (Lead Pharmacist for Self-care)
Andrew Smith (Acting Head of Advisory Service)


Wholesale dealers

The RPSGB supports the need to protect patients from counterfeit medicines entering the
supply chain. The RPSGB recognises that to do this will require changes to the way in which
wholesalers are granted licences and regulated. It is important that any changes do not create
a regulatory burden which may result in a shortage of medicines available for patients.

In particular the proposal to require disclosure of applicant’s criminal records and to require the
applicant to be able to demonstrate that s/he is a “fit and proper person” is a positive one.

Responsible Person

The RPSGB believes that it would be most appropriate for the Responsible Person (RP) to be
a pharmacist (registered with the RPSGB). As pharmacists oversee the dispensing of
medicines to patients, it follows logically that a fellow pharmacist should oversee their
distribution and handling. A number of EU Member States already insist that the RP should be
a pharmacist – thus having the RP as a pharmacist in the UK would also complement the EU

Medicines imported into the UK for export only

The RPSGB recognises the potential risks of allowing the import for export market to continue
to go on largely unregulated. However, it is also important not to over-burden legitimate
operators who may be involved in the distribution of life-saving medicines.

Therefore, while removing the exemption to subject all medicines imported for export to 3rd
countries from the full batch testing requirements may be the most effective way at limiting the
risk of counterfeits entering the supply chain this may also have a negative impact on those
legitimate operators. It could have the affect of moving activity away from EU based packing

The widening of the MHRA’s powers to inspect premises of operators that conduct “import for
export” businesses is a positive proposal that should improve regulation of this area. Could this
requirement negate the need to require packing operations that pack medicines for
subsequent export to fully test each batch of product.

Storage and Transit of Medicines

Any proposal to licence logistic providers would have to get the balance between being overly
bureaucratic and creating a system that is not robust enough to be fit for purpose.

It is sensible to give MHRA inspectors powers to review audit reports, MHRA inspectors
already have the legal powers to inspect audit reports. Will this go further to give them power
to access premises where medicines are stored? Could this be achieved by widening the
wholesale licensing arrangements?

The RPSGB supports the need to collect and analyse data on wholesale activity taking place
under Section 10(7) of the Medicines Act 1968 before taking any action. Many pharmacies
use the exemption (Section 10(7)) to obtain medicines from other pharmacies to ensure that
their patients receive the medicines they require in a timely manner. Any changes to the
legislation should not prohibit the ability of pharmacies to obtain medicines for their patients
from legitimate sources.

If the 10(7) exemption is restricted to emergencies, clear guidance would be required to define
what constitutes an emergency.

The proposal for standards for pharmacies to dispose of unused and discarded packaging
does not specify what the standards would be. Many pharmacies generate a lot of this type of
waste. Any standards should not require the pharmacist or pharmacy staff to be involved in
lengthy disposal techniques. The standard needs to ensure a robust secure route of disposal.

Criminal sanctions

Counterfeit medicines do pose a huge risk to patient safety if they enter the supply chain. It is
therefore right that these risks are recognised and appropriate penalties imposed.

Where offences are created for those handling and supplying counterfeit medicines there
should be consideration given for statutory defences if the individual could not have reasonably
know that the medicines were counterfeit. For example, if a pharmacist obtains medicines by
way of wholesale from an entirely appropriate route and a counterfeit medicine was found to
have entered the supply chain it would not be proportionate to prosecute the pharmacist who
was misled and who could not have reasonably known that the medicines were counterfeit.