HDA Media And Political Bulletin – 18 October 2016

Cost of Spain’s pharma industry to adapt production lines to medicines verification system
17 October 2016, The Pharma Letter

Spain’s pharmaceutical industry has plans to invest roughly 200 million Euros over the next two years into the adaption of its production lines. This investment is being used to incorporate the technical requirements of a new medicine verification system, as part of the European Falsified Medicines Directive and its delegated regulation. It is thought that in Spain this verifiable system will require an investment of 10 to 13 million Euros and annual support of between 5.5 and 8 million Euros.

Breaking: Just 1,380 pharmacies will be supported by Pharmacy Access Scheme
17 October 2016, Pharmacy Business, Neil Trainis

A leaked document from the Department of Health has revealed that the Government is intending to help 1 in 10 community pharmacies in England following the implementation of proposed cuts. The support will come through the Government’s Pharmacy Access Scheme which is designed to protect pharmacies from closure if they are situated in an area under-populated with community pharmacies. If a pharmacy qualifies for the scheme they will receive a top-up payment from the Government that will help ease the effect of the funding cuts. However, Labour MP Michael Dugher, believes that even with the Pharmacy Access Scheme there will be a large number of community pharmacies forced into closure if the proposed funding cuts are implemented.

This was also reported by Chemist & Druggist

You can follow the latest news and reactions to the pharmacy funding cuts at the Pharmaceutical Journal


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Cost of Spain’s pharma industry to adapt production lines to medicines verification system

17 October 2016, The Pharma Letter


The pharmaceutical industry based in Spain will invest around 200 million euros ($220 million) over the next two years in order to adapt its production lines thus incorporating the technical requirements of the new system for the unitary verification of medicines.

These are the economic estimations of the sector, based on an average cost of 300,000 euros per line, according to an announcement by the Spanish trade group Farmaindustria, noting that this is an initial investment which only looks at the adequacy of the machinery and the start up process.

Unit verification of medicines in Europe is a requirement originating from the European Falsified Medicines Directive and its delegated Regulation. Its aim is to avoid the risk of falsified drugs entering the legitimate supply chain of medicines dispensed in pharmacies, further strengthening for the patient the full guarantee of medicines dispensed in pharmacies. Spain has adapted to this European regulation, even when the current manufacturing, distribution and dispensing system in our country today makes it barely impossible for falsified medicines to enter this legal channel.

Could amount to half a million euros

These investments in production lines are the first step in attaining the full operation of the verification system taking into account that, afterwards, companies will have to face a series of diverse expenses, such as the ones derived from the maintenance and printing of datamatrix and serialization, the latter representing a figure which could amount up to half a million euros per production center.

On the other hand, each laboratory will have to take on the appropriate fee in order to develop and maintain the Spanish Drugs Verification System (SEVeM), which should be at full capacity, as in other countries of the European Union from February 2019. Thus, the launch of the verifiable system requires between 10 and 13 million Euros of investment and an annual support of between 5.5 and 8 million Euros from this year.

According to European regulations, adaptation of the production lines will work in a way so that packaging will incorporate closures to allow for verification that it has not been tampered with, and a new two-dimensional code (Datamatrix) containing a unique and random serial number for each package. These serial numbers will be placed in a European repository and pharmacies, before dispensing the medication to the patient, will need to verify the authenticity of the package by a corresponding telecommunications link with the national repository, managed by the SEVeM.

During this adaptation period of these new requirements, it is expected that the Administration will regulate certain aspects that European legislation leaves at a purely national level. In this sense, Farmaindustria maintains a close relationship with the Spanish Agency for Medicines and Health Products (AEMPS) that will contribute to the industry allowing for them to adapt to the new requirements in an environment of ongoing dialogue.

However, the high costs involved for the production centers introducing technical requirements and maintenance derived from a system of drug verification, which responds to a request from a European character, would justify the adoption of measures supported by administrations.

In this sense, Farmaindustria says it is working on different proposals so that the economic impact of the verification system is acceptable, especially for small and medium-sized enterprises, because in some cases they will have serious difficulties in coping with the expenditure required to get it up and running.



17 October 2016, Pharmacy Business, Neil Trainis


A leaked ministerial document seen by Pharmacy Business has revealed the government intends to support just 1,380 community pharmacies in England through its Pharmacy Access Scheme despite promising to help pharmacy thrive through the initiative in the wake of swingeing funding cuts.

The document, originally obtained by the Labour MP Michael Dugher, uncovers the extent to which community pharmacy will benefit from the scheme, which was designed to protect pharmacies situated in areas that are not overpopulated by other pharmacies from closure as a result of the government’

The government was supposed to decide which pharmacies would benefit by creating a national formula identifying pharmacies which, geographically speaking, are most important for patient access.

Other factors were to be considered, including distance and travel times to pharmacies and population size and needs based on age, disability and deprivation. The government has been criticised by pharmacy bodies for a lack of clarity around the scheme’s formula.

The leaked document reveals that 1,380 pharmacies, equating to 11.8% or one in 10 of the total number of pharmacies in England, will receive support through the scheme.

In the document, the government says pharmacies one mile or more from another pharmacy “will be automatically eligible” and having assessed population travel times and needs, ministers say measures are in place to “ensure that no populations with high needs levels will slip through the net in terms of access.”

The document also said that pharmacies benefiting from the Access Scheme will receive a top-up payment taking them back to their 2015-16 remuneration levels minus a 3% efficiency saving.

“Taking all of these design elements together, we estimate that the scheme will support 1,380 pharmacies, at a cost of £12 million in 2016/17 and £27 million in 2017/18,” the document said.

“From our initial calculations, the vast majority of qualifying pharmacies will be opted in through the first rule (the ‘mile or more’ rule) and only a handful will be opted in through scoring highly on the index.

“As a rough indication, we would expect the estimated average payment per pharmacy to be £8,500 in 2016/17 and £19,500 in 2017/18.”

The document contradicts a promise made in December last year by Alistair Burt, the former minister responsible for pharmacy, who said: “Our aim is to ensure that those community pharmacies upon which people depend continue to thrive and so are consulting on the introduction of a Pharmacy Access Scheme, which will provide more NHS funds to certain pharmacies compared with others, considering factors such as location and the health needs of the local population.”

Dugher, who has campaigned vociferously against the cuts to pharmacy funding, accused the government of breaking its promise on the scheme.

“Ministers promised they would listen and consult widely on their planned cost-cutting, but the government is set to force through a brutal package of cuts that could leave many frail and vulnerable patients forced to walk a mile or more to get medicines they need,” he said.

“And we now find they are planning to arbitrarily impose a relief scheme that could still see the closure of many local pharmacies.

“These ill-judged cuts are bad for our communities and bad for our NHS because community pharmacies help to save money by providing free advice and dispensing medicine before patients head to their GP or A&E.

“Ministers must think again and recognise the vital role that community pharmacies play in frontline healthcare before they sound the death knell of thousands of local chemists.”


Only 1 in 10 pharmacies to benefit from cuts relief fund

17 October 2016, Chemist & Druggist, Annabelle Collins


Just one in 10 pharmacies will be given financial support as part of the government’s planned fund to provide relief from the cuts, a leaked document has revealed.

The Department of Health (DH) estimates its pharmacy access scheme – first proposed to ensure “geographically important” pharmacies are not forced to shut their doors as a result of a cut to the sector’s funding – will only support 1,380 of  the 11,674 in England, according to a leaked government document seen by C+D.

The document – obtained by Labour MP Michael Dugher and shared with C+D yesterday (October 16) – states that the scheme would cost a total of £12 million in 2016-17 and £27m in 2017-18.

It details two categories of eligibility for pharmacies to qualify for the funding. Pharmacies located a mile or more from another pharmacy will be “automatically eligible”, while a “handful” will also receive the funding if “population mapping” shows they are needed to provide care to a “high-need” patient group, according to the document.

The top 25% of pharmacies – based on dispensing volume – will be automatically excluded, as those with “greatest potential to remain viable” should not receive support, the DH stressed in the document.

It estimates that the average payment per pharmacy from the funding will be £8,500 in 2016-17 and £19,500 in 2017-18.

In January, the DH announced plans to “phase out” the current system of establishment payments completely “over a number of years”.

Efficiencies needed by all

According to the document, even pharmacies that are eligible for the fund will have to make efficiencies.

While the top-up payment is designed to bring the funding of eligible pharmacies back up to 2015-16 levels, they will still be required to make a 3% efficiency saving.

The DH said in the document that it “is keen” to discuss the proposals in further detail and called for the Pharmaceutical Services Negotiating Committee’s (PSNC) input.

Last week (October 13), PSNC outlined its 16 objections to the pharmacy access scheme in a letter to the DH’s head of pharmacy Jeannette Howe. The following day, the negotiator rejected the government’s plans to slash the sector’s funding by 12% from December.

The DH declined to comment on the leaked document.

HDA Media And Political Bulletin – 18 October 2016

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