The Pharmacist September/October 2018 - Page 14

COVER STORY Another difficulty could arise when new European medicines enter the country. Following the Brexit vote, the European Medicines Agency (EMA) – which approves the use of most new medicines sold across the bloc – relocated its London headquarters to Amsterdam. Under a centralised procedure, new medicines such as gene therapies and cancer treatments are authorised in all EU countries at the same time to ensure that no individual country is left out. After leaving the EU, Britain might have to submit a marketing authorisation for a new medicine to the EU first and then to UK drug regulator the Medicines and Healthcare products Regulatory Agency (MHRA). This new process could create substantial workload for the MHRA and reduce the number of authorisations it is capable of granting. This in turn could result in extra costs. ‘As a highly regulated industry, the prospect of regulatory divergence from the EMA is the deepest concern for the industry,’ the House of Commons report reads. ‘A divergent regime could see extra costs of £45,000 for each new medicine released in the UK, making the UK an unattractive small market for specialised medicines and risking the loss of access entirely to some products.’ Government stockpiling plans According to NHS Digital, community pharmacies dispense more than one billion items a year, accounting for more than £17.4bn in spending. In August, the Government unveiled plans to maintain a ‘sufficient and seamless supply of medicines’ in the UK in the event of a no-deal Brexit. In a letter, health and social care secretary Matt Hancock asked pharmaceutical companies to hold an additional six weeks’ worth of medicines on the top of their usual buffer stocks. Although the initiative sounds sensible on the surface, pharmacy leaders believe it might not be ambitious enough to meet the UK’s demand. Mr Soni argues that the plan could create concern among the public, who could then start to stockpile medicines. He says: ‘It’s a good thing that somebody is thinking about what needs to be done to 14 | The Pharmacist | September/October 2018 In the midst of uncertainty, we would really need clear guidance, flexibility and better staging Ade Williams make sure we have sufficient stock for the UK market. ‘But one of the things that happens when you do that is that you create a whole emphasis for panic, and if you create panic it’s likely that what you’re talking about as being a potential becomes reality. ‘That will have real implications on how long the stock will last. It’s all very well to say you need to have stocks for six weeks. But if you were in a position where the public is concerned they may start to look at increasing what they’re holding. [Then] that [stockpile] doesn’t last six weeks, but four.’ Echoing his comments, the National Pharmacy Association’s (NPA) public affairs manager Gareth Jones adds that we might start seeing ‘significant pressures on pharmacy and demands for prescriptions from GPs’. He tells The Pharmacist: ‘A six-week stockpile is a positive start but there are further scenarios we need to consider that may occur over the next six months. ‘It’s not [exclusively] about what the manufacturers and wholesalers can do – there is a human element on the front line that we have to deal with. We may need more than simply a six-week stockpile [plan] to deal with that’. Responding to those concerns, the Department of Health and Social Care (DHSC) says that it will work with stakeholder companies, including those in the supply chain, to ensure stockpiles of drugs in the UK are ‘appropriate to cope with delays that may arise at the border in a post-Brexit UK’. Rise in prices The price of generic medicines is affected by the law of supply and demand. When there are more products than demand, the price tends to fall. Likewise, when the demand for a product is high and the supply low, the price increases. Mike Hewitson, superintendent pharmacist at Bedminster Pharmacy in Dorset, believes that if patients start to buy more medicines, there will be price hikes come the autumn. ‘We’ve seen news footage of patients with diabetes being concerned about insulin supplies and consequently we might start seeing patient behaviour change, which means they could start to order an excess of medicines,’ he says. ‘My concern is that through the autumn, we’ll start to see prices increase and sporadic stock shortages on particular products.’ Brexit uncertainties Over the past few years, community pharmacists have faced \[\؜X\š[Y[ܝY\H[[]˜[]YܞHH]ؘXX][YHۂH[و\K&[HZYو[\Z[KHX[BYYX\ZY[K^X[]H[]\Y[8&H^\YH[X[\\\[[[\XX\]YZ[\\XXH[\ &[X]\HH\H]H[YH[HZXYو\]YB]Y\[ۜΈ\HH[XZH\B]H\HHݚYH]Y[۸&]H[\YY[Hx&\HZ[]Y]B\[[\H[[H\[H[HX܈ZHۈ[H[]]H[[X[[YZ[\]]H\\[BH][O&B\HX܈\X[YYY\˜[K]]HYXو^]Y]˜HY[[\]Y\[ۈYYH\Y\XX\]H[\X\Z\Y]\\]H\^YX[O“0XHYܘZY[\H\XX\8&\\ܝ\