1 JUNE 2020 - UPDATE ON MARKET ENTRY...... and THANK YOU FROM CONOR DALY TO EVERYONE WHO HAS HELPED IN THE LAST FEW MONTHS

Since the announcement two weeks ago that Market Entry would be returning to some sort of normality from 1 June, there was a marked and immediate increase in the processing of applications and decisions. We have several clients who are still waiting for decisions on applications that should have been received and it is clear that even if Market Entry processes are back to normal, there is a significant backlog of work to clear. The good news is that this backlog will clear and with any luck there will be no need for further updates to this section of the website.

Over the last couple of months I have had the pleasure to work with some amazing people and tackle some really difficult and complex problems ranging from getting places in a school for children of pharmacy workers who were initially denied places to assisting with pharmacists facing cash flow problems and managing to get NHS England to issue decisions during lockdown in urgent cases and even advising on government calls relating to pharmacy issues. I am very grateful for those who have stepped in as soon as I called to ask for help, from QC's at barristers chambers to the CEO of one of the largest healthcare companies in the UK and to organisations like the PSNC who were prepared to step in and help with queries. Everybody I asked for help not only said yes, but did so immediately and without hesitation or thought of what was in it for them. Thank you.

 

14 May 2020 - UPDATE ON MARKET ENTRY

MARKET ENTRY FOR PHARMACY APPLICATIONS STARTING AGAIN AND TO BE FULLY RESUMED BY 1 JUNE 2020

Despite the difficult times we are all in there are a lot of pharmacy contractors who have Market Entry applications in the system. I have had numerous conversations with PCSE and PSNC about the current suspension of Market Entry. I am now seeing some application work starting again and they aim to be back to normal (but with a backlog of work) by 1 June 2020. Surprisingly I am still being told that NHSE will be “pragmatic” when it comes to regulatory deadlines. Unfortunately there is no room for pragmatism in this area as the deadlines are set by Regulations and there is no ability to change them without a change in legislation. Despite this I have seen some deadlines extended and unless an affected party challenges the extension it will probably apply even though it is unlawful. We have been working with clients to submit applications during the suspension period as they are likely to be considered in date order. We are still offering free advice in this area and any other area where contractors have been affected due to coronavirus issues so feel free to get in touch, ideally by emai.

 

 

28 April 2020 - UPDATE ON MARKET ENTRY

Following the recent announcement of a suspension of Pharmacy Market Entry I contacted the PSNC and asked for clarification on a number of points. One of my main concerns is that NHSE has no option other than to follow the current Regulations and, unless there is a change to the law, they cannot ignore timescales set out in those Regulations. NHSE is permitted to defer consideration of new applications under the current Regulations and they are broadly doing this, but the PSNC has now clarified that applications which have not been deferred must continue as per the current regulatory timescales unless or until there is a change to the Regulations that govern Market Entry.

There have been mixed messages coming from PCSE and NHSE in recent weeks and they have not been following the time limits imposed by the Regulations. This may seem trivial to many, but it could lead to substantial losses for some pharmacy contractors and it is vital that anyone involved in a Market Entry application, whether as an Applicant or Objector understands the rules properly. NHSE has an obligation to notify Applicants of a deferral and the reasons for that deferral and this is not addressed in the new guidance.

I expect that we will see a change in the law to follow, but for now the current Regulations apply in full.

The new PSNC guidance states;

Pre-determination applications

PSNC has been informed that applications before NHSE&I has made a decision were suspended for good cause under the regulations – that good cause being the COVID-19 outbreak. If there are pressing reasons why an application should now proceed – for business or pharmacy service continuity or pressing reasons for the contractor – NHSE&I may progress that application. Applicants will have received an email from Primary Care Support England (PCSE) advising them of what they should do if they wish to ask NHSE&I to continue to progress their application.

Business or pharmacy service continuity could include consolidations, closures (for example, as part of a business merger), relocations and change of ownership applications. Pressing reasons for contractors might involve, for example, issues associated with leases and health and safety requirements (e.g. social distancing concerns). Applications for a new pharmacy to fulfil a need or fulfil an unforeseen benefit, and applications for distance selling pharmacies (DSPs) are unlikely to be given priority at this time.

Post-determination applications

The suspension of market entry activity only applies to those applications which have not yet been determined by NHSE&I. Where NHSE&I has reached a decision on the application and that decision has been notified to the applicant and interested parties, then the usual timescales apply. For the avoidance of doubt this means that:

  • Appeals against decisions must still be submitted to NHS Resolution (or the First-tier Tribunal in relation to decisions to refuse an application on fitness grounds) within 30 days;
  • Where an applicant gave a best estimate they must notify NHSE&I, via PCSE, of their premises within six months of the decision to grant an application being notified to the applicant;
  • Notices of commencement and notices of consolidation must still be submitted within six months of a decision to grant an application being notified to the applicant; and
  • NHSE&I may only extend the six month grant period by up to three months. No further extensions may be granted by NHSE&I.

Contractors are advised to check deadlines and act accordingly. NHSE&I is considering steps to assist contractors, as appropriate, and PSNC is in discussion with NHSE&I on this. More information will be available in due course.

Temporary closures or relocations

Applications relating to a temporary closure or relocation due to the COVID-19 outbreak and made under paragraph 27, Schedule 4 of the regulations are not covered by this suspension and contractors should therefore submit such applications directly to the relevant NHSE&I regional team.

PSNC seeking new regulations

PSNC has also requested changes to the NHS pharmaceutical regulations as soon as practicable, to assist management of market entry cases at the current time. PSNC is keen to ensure that contractors are not disadvantaged by the suspension and any issues arising from it are resolved fairly for all – for those making applications and for those who were protected from the need to read and respond to applications at the early stages of the outbreak.

 

 

 

16 APRIL 2020 - THE PHARMACY VOLUNTEER DELIVERY SERVICE - PROCEED WITH CAUTION, OR BETTER STILL, DON'T PROCEED AT ALL

Of all the new services to come out of the current pandemic, the pharmacy volunteer service must be the worst. This should not be confused with the delivery service described in the post below, but instead applies when the pharmacy uses a volunteer to deliver medicines. I do not intend to go through the detail of the service, because frankly it is next to useless and I would only use it as an absolute last resort. The Royal Pharmaceutical Society and the GPhC have not helped matters by writing letters (which they then had to clarify) to say pharmacy teams using NHS volunteers “in line with the service specifications of the pandemic delivery service” would not be “regarded as responsible for actions of other people outside of their control”. I am amazed that such a poorly thought through statement made its way through a professional body and a regulator. Firstly, it is of no reassurance anyway as it has the lovely catch all of "in line with the service specifications" in it. What this means is simple, if you do something wrong due to huge pressure and stress then you are not protected. However, the letter was even worse as it is the courts who will decide liability and not the RPS or GPhC.

For what it is worth my advice is simple. Make sure the patient provides the volunteer and not the pharmacy or, just use the pharmacy's existing delivery service and make sure any new employees in delivery roles really do understand the Delivery SOP before they go out on the road. In most areas there are local community groups (official and unofficial) that have arranged volunteers for various reasons and the pharmacy could provide the details of those services to the patient (without a recommendation).

If a shielding patient needs help collecting prescriptions advise them to call 0808 196 3646 (8am to 8pm) to seek volunteer assistance as this is the number for the NHS Volunteer Responders helpline and does not need a referral from a medical professional.

 

11 APRIL 2020 - NEW DELIVERY SERVICE DETAILS ANNOUNCED

AVERAGE PHARMACY TO RECEIVE £500 PER MONTH FOR CORONAVIRUS DELIVERY SERVICE AND £5 PER DELIVERY. Key points to be,

1. Does not apply to distance selling pharmacies.

2. Automatic payment based on dispensing volumes.

3. Payment ranges from £34 for those dispensing under 2,500 items to £563 for those dispensing over 19,168 items. Most pharmacies will receive £500 (for pharmacies dispensing 5,001 to 12,500 items).

4. Applies only to patients who are “shielding”. NB this means that the delivery fee is NOT payable for most deliveries that pharmacies routinely offer.

5. An additional new Advanced Service which pays £5 per delivery for patient to who are shielding.

6. The delivery service is optional, but those opting out must make arrangements with another pharmacy to dispense the prescription and deliver it (that is what the £500 is for) or deliver it themselves (and claim the extra £5 fee). In summary, most pharmacies (except distance selling) will receive £500 per month and for this are obliged to either offer the delivery service (for an extra £5 per delivery) or arrange for another pharmacy to deliver.

All payments are in addition to the global sum and are therefore “new money”.

Details for claiming are on the PSNC website.

 

6 APRIL 2020 - Can Pharmacy Contractors Furlough Employees?

Whilst everyone will be aware of the government "furlough" scheme by now, the details in some areas are not clear. For example, employment consultants are advising pharmacies that they CANNOT furlough employees, even those who are in a high risk group and are shielding. These employment firms say that this is because pharmacy is funded by the government and that is one of the exceptions to being allowed to furlough employees. Despite this I am aware of at least one of the largest national pharmacy chains which is furloughing employees in certain Head Office functions. I have been in contact with the PSNC and asked them to provide further guidance on this as a matter of urgency.

It is also interesting to note that the British Dental Association, whose members face the same problem, appears to have just clarified with government that their members' employees are eligible for the scheme, so it seems highly likely that pharmacy staff will also be included.

 

UPDATE - further to my request for clarification, the Department for Health and Social Care have stated as follows;

Treasury has confirmed that those who are classed as employees and receive a salary through a PAYE scheme could be eligible, provided they carry out no work for their employer while furloughed and they meet the other criteria for the scheme.

 

Unfortunately this update does not answer the question as it says "could" rather than "will" be eligible. My view remains that pharmacy staff are eligible, but it would be helpful if government did not provide statements like this which are meaningless when they are specifically being asked to clarify the position.

 

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1 APRIL 2020 - Pharmacy Market Entry Suspended

The lastest update from NHS England is that from 25 March
"NHS England and NHS Improvement and Primary Care Support England will suspend market entry applications to allow staff who work on these tasks to be redeployed to functions which have higher priority during the current pandemic."

We are requesting clarification on how this will impact on those who are in the process of opening new pharmacies or relocating and have a set period of time to do so as this might otherwise prevent pharmacies from opening that could help with the pandemic response. The same issue applies to applications for temporary emergency relocations and chages of ownership.

I am also still seeing some processing of applications, so it does not appear to be a ban on processing at this stage.

UPDATE - On 10 April 2020 PSNC confirmed that they were still seeking clarification about the types of applications we have listed above. in addition, Primary Care Appeals has updated that they will still be considering appeals, but any oral hearings will have to be postponed.

UPDATE - Although it is not an official announcement, it is becoming clearer that NHSE are still processing some applications where there is a need to do so to prevent hardship or difficulty for patients. I remain concerned about the comments being made about "stopping the clock" on pharmacy applications. There is a big difference between stopping the processing of applications (which is permissible) and ignoring deadlines imposed by the Regulations (which is not). NHSE will need to be very careful in applying this new policy as whilst it seems sensible, we will one day by out of the current crisis and it will not be long before people who sound supportive now start to take a much harder approach to everything.

 

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On Sunday 22 March 2020 the PSNC released details of a new agreement on NHS pharmacy opening hours as well as an SOP for use in the pharmacy to help deal with COVID-19.

I have received a lot of enquiries on the same point here and will update on opening hours first and provide more details later.

All pharmacies will be expected, on every day they have contracted opening hours, to be open to the public between 10am and 12 noon and 2pm and 4pm as a minimum (if these are contracted hours).

100 hours pharmacies  are being treated the same way and should be open from 10am–12pm and 2pm–6pm as a minimum -but 100 hour pharmacies should note that this only applies to days when they have contracted hours that cover those times. So if your 100 hour pharmacy does not normally open on Sunday, or does not normally open from 2pm to 6pm on a day then you are not required to start opening those times now.

There may be some confusion as the PSNC statement says that pharmacies can close for "up to 2.5 hours", but if pharmacies apply the minimum hours listed above then this would be more than 2.5 hours for most pharmacies. We are seeking clarification from the PSNC on this. UPDATE - I have spoken with the PSNC and they are trying to agree with NHSE that anyone who operates for at least the minimum hours will not have to notify NHSE about their closure. At present the thinking is that any closure of more than 2.5 hours in total should be notified when it is practical to do so (which is in line with the current Regulations)

The PSNC wording is shown below and the SOP their webpage can be accessed by clicking here.

Opening hours flexibility

Specifically:

• If under significant pressure, at the discretion of the responsible pharmacist, pharmacies may close their doors to the public for up to 2.5 hours a day, including lunch.
• Community pharmacies are expected to be open to the public between 10am-12 noon and 2pm-4pm as a minimum (if these are contracted core or supplementary hours).
• Similarly, 100 hours pharmacies should be open from 10am–12pm and 2pm–6pm as a minimum.

A sign on the door must give information about how to contact the pharmacy if urgent help is needed.

Temporary closures

NHSE&I has also stated that for temporary closures (not closed-door working), for instance where not enough staff are available to work, NHSE&I must be informed immediately. The pharmacy NHS 111 Directory of Services (DoS) profile must be updated, as must the NHS Website.

NHSE&I is encouraging cooperation between community pharmacies and GP practices in primary care networks, to deliver the best care, and protect and maximise the capabilities of staff across practices and pharmacies.

NHSE&I also encourages local pharmacies to work to maintain continuity of services in the event of temporary closures through ‘buddy’ arrangements, stating:

Particular thought should be given to patients receiving services such as supervised consumption or monitored dosage systems. Consideration can be given to providing daily doses rather than supervised consumption on an individual patient risk assessed basis.

The new guidance from NHSE&I is included in the pharmacy SOP updated today. Read the SOP