Pharmacy wholesaling and dispensing activities need to be legally separated, so that pharmacies who serve NHS patients directly prioritise the UK patient over and above wholesaling activities which effectively divert medicine supplies, MPs have been told.
A legal separation would ensure there is a clear audit trail of transactions between the pharmacy's wholesaling and pharmacy activities, permit suppliers to the pharmacy to know which entity they were supplying and therefore invoicing, and allow the regulator to see a clear audit trail of transactions, if and when required at inspection, according to the Association of the British Pharmaceutical Industry.
Suppliers would then be able to prioritise which part of the business they will supply when a product is in short supply, the research-based industry group has told the parliamentary All-Party Pharmacy Group's inquiry into medicines shortages.
The ABPI also expresses concern at the level of regulatory oversight and inspection of the trade in medicines. There are currently around 1,800 wholesaler dealer licenses in the UK - apart from Germany, the highest number in Europe by a significant margin - and the Medicines and Healthcare products Regulatory Agency does not have the resources to inspect the premises of 1,800 wholesale dealers, it says.
There needs to be a change in regulation, the industry group has told the MPs. It welcomes the proposed repeal of Section 10(7) of the Medicines Act 1968, an exemption which currently allows pharmacy to trade up to 5% of its turnover without a wholesaler dealer licence, but calls for the change to go further, with a restriction on the exemption which permits pharmacies to be able to hold a wholesale dealer license and thus, to wholesale trade.
The ABPI also tells the inquiry that it does not support calls for the adoption of a Public Service Obligation, to include a 24-hour requirement to supply medicines, in the UK. "This would only increase the quantity of medicines into the system - and therefore being diverted into Europe - whilst also introducing unnecessary red tape," it warns.
Moreover, there is no data to show that PSOs work in other EU member states to solve the medicines shortages which they have suffered when they were net exporters, says the ABPI. It also cautions that an Obligation would be a challenge to enforce, given that demand then becomes short-term and more unpredictable, and the lead time on medicines is several months.
"To be effective, the 24-hour obligation would also need to be on all elements of the supply chain - pharmacies, wholesalers, repackers and manufacturers," it says.
The ABPI calls on wholesalers to support its position on the repeal of Section 10(7) of the Medicines Act, and urges Minister to "lead a shift in perception about the acceptability of supply diversion and demonstrate a willingness to take the necessary regulatory steps through the MHRA to address the challenge."
So far, the government has indicated that it does not feel the situation justifies a change in regulation and prefers the various stakeholders to find a solution amongst themselves, without the need for regulation, but the Department of Health Supply Chain Forum set up to tackle the problem in England has not yet found a solution, and there is scepticism among stakeholders as to whether the best practice guidance issued by the Forum will have any real impact, says the ABPI.
The industry group also tells MPs that it has recently convened a Pharmacy Advisory Group to "build a forum around which everyone involved in this highly-concerning issue can convene to find mutually-agreeable solutions." The exemption in Section 10(7) is being removed because it is not compatible with the European Union Falsified Medicines Directive, which must be implemented by January 2 next year.
Look out for our article on the FMD in the February issue of PharmaTimes Magazine, Click here