Thinking about market entry, we were told all about the new market entry regulations based on the pharmaceutical needs assessment (PNA), for both routine applications and Excepted applications (change of ownership, minor relocation, or distant selling), and the associated guidance issued by the DOH to help implement the regulations.
We considered, and discussed, examples to ensure that we will be better prepared for contract applications made under the new regulations - given that the LPC is recognised as the official body representing contractors in the PCT area.
On receiving an application, the PCT must determine whether granting it would meet a current need for pharmaceutical services and must consider whether to invite other applications. If it does this, the PCT can defer the application and consider all of them together. The PCT can refuse the application for a variety of reasons including "if it considers that to grant the application would lead to an undesirable increase in the availability of essential services."
The regulations place a number of obligations on applicants and the PCTs - and hopefully will make market entry a more sensible process and so it's all change with applications - the necessary/desirability clauses have gone.
Thinking about market exit, we also considered the sanctions that PCTs (or successor) bodies can make on existing contractors...
Regulation 69 states that, if there is a dispute, there is a requirement to attempt local resolution first - unless the PCT is satisfied that it is appropriate to move further at once due to the severity of the dispute (perhaps the pharmacy premises have not been open during core hours, or to protect the safety of the public or to protect revenue of the PCT etc.).
If this is not achieved then regulation 70 allows for a remedial notice to be issued by the PCT and regulation 71 provides for abreach notice to be issued. If the dispute relates to a failure to provide, or failure to provide at a reasonable standard, a service that the contractor is required to provide, then the PCT can withhold part, or all, of the remuneration due to the contractor (according to guidelines).
In essence, then, these are financial penalties (fines?) which will be applied to contractors in certain instances for failure to carry out obligations under the contractual framework, such as audits, patient questionnaires etc. or perhaps failure to provide an enhanced service to a reasonable standard!
Failure to improve or carry out remedial action may, as an ultimate sanction, lead to removal of the contractor from the PCT pharmaceutical list...