Medicines: Fees
We want to hear your views on the regulations that cover fees payable for the regulation of medicines, including herbal and homeopathic medicines, and blood establishments and blood banks. What more we can do to deliver a simpler, less bureaucratic and more effective system and foster growth and innovation. You can find the regulations that relate to Fees to the left below.
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Blood Safety and Quality (Fees Amendment) Regulations 2010, SI 2010/554 Impacts on fees for blood safety and quality services by increasing the fees for blood establishments and hospital blood banks by approximately 1% for authorisation, operation, and haemovigilance services and introducing a fee for written representations to, or appearing before, a person appointed by the Secretary of State. Read More… (opens in a new window)
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Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2005, SI 2005/2061 Extends the Medicines and Healthcare products Regulatory Agency’s remit in relation to blood safety and quality and restrict the remit to exclude the Department of Health’s activities relating to the evaluation of medical devices. Read More… (opens in a new window)
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Medicines for Human Use and Medical Devices (Fees Amendments) (No 2) Regulations 2007, SI 2007/803 Introduces a new registration procedure for certain homeopathic medicinal products and increases the fees payable for registration, pharmacovigilance advice and risk-management systems of licence holders and inspections. Introduces a periodic fee for homoeopathic and anthroposophic medicinal products. Read More… (opens in a new window)
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Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2003, SI 2003/625 Makes changes to the Homeopathic Medicinal Products for Human Use, the Medical Devices Fees and other areas of work done by the regulatory authority by increasing the amounts of the fees payable for applications for certificates of registration, fees payable by holders of certificates of registration, fees for consultation on Devices and fees for other areas of work done. Read More… (opens in a new window)
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Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999, SI 1999/566 Makes further changes to the fees for Homeopathic Medicinal Products, Medical Devices and Medicines by introducing discounts on certain types of registrations of homeopathic products, increasing the fees on Medical Device consultation and increasing fees relating to other licences for medicines. Read More… (opens in a new window)
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Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000, SI 2000/592 Increases the amount of fees charged for applications for certificates and the annual periodic fee for homoeopathic medicines; the amount of fees charged for consultation with notified bodies about medical devices; and the amount of fees charged for marketing authorisations, licences, certificates and annual periodic fees relating to medicinal products, manufacturers, wholesale dealers and clinical trials. Read More… (opens in a new window)
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Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001, SI 2001/795 Amends various definitions and requirements for fees in the Medical Devices (Consultation Requirements) (Fees) Regulations 1995, the Medicines (Products for Human Use—Fees) Regulations 1995, the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 and the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994. Read More… (opens in a new window)
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Medicines (Products for Human Use) (Fees) Regulations 2010, SI 2010/551 Defines the fees that should be paid including marketing authorisations, wholesaler dealer’s and export licenses, clinical trial authorisations, herbal registrations, medicines labelling and leaflets and inspections, and introduces new fees under the decentralised procedure and for assessment of various good practice. Read More… (opens in a new window)
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Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002, SI 2002/542 Amends various definitions and requirements for fees to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”), the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the Marketing Authorisations Regulations”), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”) and the Medicines (Products for Human Use-Fees) Regulations 1995 (“the General Fees Regulations”). Read More… (opens in a new window)
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The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003/1076 Sets up, as from 1st April 2003, a fund with public money under the Government Trading Funds Act 1973 for the operations of the part of the Department of Health, to be known from that date as the Medicines and Healthcare products Regulatory Agency as a result from the merger of the Medicines Control Agency and the Medical Devices Agency. Read More… (opens in a new window)
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Medicines (Fixing of Fees Relating to Medicinal Products For Human Use) Order 1989, SI 1989/684 Specifies what needs to be taken into account when deciding what fees apply under the Medicines Act 1971. Read More… (opens in a new window)
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Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Amendment Order 1995, SI 1995/871 Disestablishes the Committee on Review of Medicines and the Committee on Dental and Surgical Materials and takes into account the functions and enforcement of the Licensing Authority under the Medicines for Human Use Regulations 1994. Read More… (opens in a new window)
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Medicines (Products for Human Use) (Amendments relating to Fees for Variations) Regulations 2009, SI 2009/3222 Amends the current legislation in respect of the fees payable for an application to change the terms of a marketing authorisation for a medicinal product for human use and to reflect changes to the types of applications. Read More… (opens in a new window)
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Medicines for Human Use (Fees Amendments) Regulations 2006, SI 2006/2125 Allows for a periodic fee to be charged for a marketing authorisation of a national homeopathic medicinal product and reduced fees to be payable for homeopathic medicinal products that have a certification of registration. Read More… (opens in a new window)
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Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003, SI 2003/2321 Amends the Medicines Act 1968, and related regulations on Medicines for Human Use. Measures include setting out standards in respect of the testing of medicinal products; and conditions for fees. Read More… (opens in a new window)
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Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?
MHRA policies result in poor communication of information about drugs. Because of the fees for updating an SmPC, companies will only do this when they are absolutely required to (e.g. safety issue) or when there is a commercial advantage. Minor changes accumulate until it is worth paying the fee. This means that outdated information is distributed for the interim period. The licensing fee should include updates are reasonable intervals.
Similarly, the fee for updating manufacturing licences means that changes are not made until several have accumulated. GMP inspections start with review of the licence and considerable time is wasted correcting errors. Furthermore, the updating of a licence often results in even more errors being incorporated and the MHRA has been unhelpful in resolving this. We have offered to go into the MHRA office to help with the changes but this has been refused.
Fee Categories – Too many categories of fees for variations and CT submissions. It is confusing for the industry to choose a correct category among so many. Also, more often than not, there is a disagreement between MHRA and the industry on the category of fees chosen for a particular submission. I understand that the MHRA have proposed new fees for Variations for 2012 which should eliminate our issues there but I have not seen anything for CT so the previous comment would still apply for CT applications. On a positive note, we feel that the CT process works pretty well and is well aligned with the EU guidance.
Fee allocation and resolution issues – Misallocation of fees has been a historical issue with the MHRA, and though they have been trying to get over it with the launch of the iRIS system, there is still a need for an easier and straightforward way to resolve outstanding issues. Any finance manager from the industry should be able to easily contact a senior finance personnel in the MHRA to take prompt decisions about outstanding funds on either side.
We find the need to pay our periodic fees in full prior to submission to our return an impossible financial burden on our company. The fees invoice is normally at least double what we end up having to pay. However, we have only just received our credit for fees that we paid almost 10 months ago. There has to be a better way to process these fees – our business is not there to provide and interest fee loan to the MHRA.Comment Tags: Periodic fees
Initially the legislation was set up to safeguard public health and this has to remain the objective. However, the legislation seems to be tailor-made for multi-million pound pharmaceutical companies who can afford several mega-investments each year in the hope that one or more will reach the marketplace and create large profits.
Small companies, wishing to provide a useful/helpful product, but with small budgets and future prospects of modest profits should NOT be in the same category as Big Pharma. Many UK companies could create healthcare products for home use and also for export, thus helping with balance of payments. At the moment, the costs involved, the hugely complex paperwork and the many other hurdles encountered by well-meaning companies has created a ‘no-go zone’. The UK and EU regulations seem to be hitting small companies ‘into the long grass’ leaving the way clear for pharmaceutical companies to market their products unchallenged by a cheaper/effective/safer alternative product. But the fact that Big Pharma has taken a gamble with its new molecules and concepts means that every new product to market increases the financial burden on the NHS, as every pharmaceutical product needs to return a profit to its creators before the patent runs out. this situation is bad news for the UK public, as there might be cheap and effective medicine consigned to the back shelf for lack of the financial ability to pay the same fees as Big Pharma. It is bad news for the NHS and seems to me to threaten its very survival because of the enormous and increasing annual drugs bill. There should be a two-tier system. Leave the vastly expensive and difficult regulations to the large companies but introduce a fairer, cheaper, easier system to the small companies who have the ideas and knowledge to create products from herbs, essential oils, homeopathic preparations and the array of useful products to be found in foods, oils, vitamins, etc. With so many superbugs taking the lives of UK citizens, surely the government should be OPENING UP the market and actively inviting companies to suggest ways in which natural/already proven-to-be-safe products could save the NHS money.Comment Tags: essential oils, save the NHS money, superbugs
Further simplification of the MHRA fee structure would be welcomed, particularly for CTA applications and also for variations. Fees have to be paid upfront for variations and CTAs: the fees considered applicable by the Company and the MHRA are often divergent, enormous amounts of resource (company and MHRA) are spent on trying to tally the subsequent invoices from and payments to the MHRA. The MHRA should either move to invoicing all fees after the fact, so that one payment is made that is clear and visible to all parties, or simplify the fees paid in advance so that room for error on the part of the company is diminshed. E.g. for CTAs rather than having multiple possible CTA fees have one type e.g. the same CTA fee regardless of whether the molecule has been “seen” before or whether it is phase 1, 2 or 3. Annual CTA fees should be scrapped altoegether. MHRA accounts should send any fee request to the organisation submitting the CTA and not chase the Sponsor for payment when the trial has been outsourced to a CRO and the intial submission and payment has been done by the CRO.Comment Tags: CTA fees and variation fees
The annual HTA license fee has increased enormously and places a huge burden on small industry and academia. It seems that the scope of the agency has gone beyond the intended aims.
The purpose of the annual CTA fee is unclear, other than covering the costs of adminstering it. It should be scrapped, particularly for not-for-profits who have to waste valuable charity money paying it.Comment Tags: CTA annual fee
The regulation that dictates that fees should be paid at the point of submission, with proof of payment provided as part of the submission should be scrapped. Industry complies with this and then is always invoiced separately for the amount (although it is already paid). The variations submitted should be invoiced with the stipulation that unless paid no assessment/approval will be progressed. The matching of invoice to pre-payment is burdensome on our finance Departments as well as time-consuming for the MHRA finance Department so invoice and then payment of invoice should simplify matters.
Medicinal Product Licence variations – As a 61.3 Notification (National BROMI) is similar to a Type IA variation in that it is not assessed, it should not attract a fee. The current fee should be scrapped.