The core role of a successful generic medicines manufacturing sector is to get the right medicines at the right time to patients to improve quality of life. This work also stimulates the originator sector to continue research-based activity which results in new and improved medicines for patients.
There are a number of issues, which are important to our members, in which we engage with a range of stakeholders from parliamentary representatives and government departments, through to the European Union.
The UK's medicines regulator 'the MHRA' rightly has a strong and positive reputation amongst its peers in the EU for its contribution and scientific expertise. Indeed, it delivers the largest share of the work in reviewing applications for pan-European marketing authorisations, of which the generic sector is the biggest user.
In the key area of new product registrations, BGMA has been closely surveying MHRA performance year on year and identifying areas requiring improvement, for discussion with the regulator. This has resulted in major improvement in the time taken for new generic medicines to be registered in the UK. This is greatly assisting the predictable timely availability of generic medicines for patients, healthcare professionals and has also resulted in NHS cost savings.
In other areas of regulation, such as changes to existing approved medicines and transferring licences, there is still a need for MHRA to focus and improve, particularly on the time taken to reach decisions.
With the increasing weight of new legislation coming from Europe, the BGMA continues to work closely with MHRA to ensure its drafting and UK implementation is well managed, and minimises red tape and over regulation. This safeguards the sustainability of the NHS, so that affordable generic medicines are quickly available to patients, allowing the NHS to afford other treatments and expensive innovative medicines for unmet clinical needs.
The volume of patent applications has increased substantially in the past decade, with a proportion of those apparently aimed at deterring generic competition.
Given the volume and unnecessary complexity of some patent clusters - which in certain examples have totalled nearly 1,300 patent applications around a single molecule - it is extremely difficult for generic manufacturers, particularly SMEs, to be confident they would not be in legal breach by launching their product. These practices limit competition and the prospect of lower medicine prices.
We are very concerned that the issue of these type of weak patents - those which don't fully meet accepted criteria - may be aimed at delaying generic competition.
It is crucial that competition authorities ensure that the operation of markets reverts to what was originally intended: that originators receive long periods of market monopoly on their products during the patent term so that they can recoup their research investment, followed by the immediate onset of generic competition to make medicines affordable and to promote true innovation.
Biopharmaceutical medicines already play a critical role in the effective treatment of many serious diseases and their importance continues to grow. Affordable follow-on versions of several such medicines already exist across the European Union and are creating increased competition which delivers significant benefits and savings for patients and payers. They are approved as biosimilar medicines by the European Commission, on the recommendation of its scientific advisory body, the European Medicines Agency (EMA), under the existing Centralised Procedure. Approval is granted on the basis that they have demonstrated comparable quality, safety and efficacy to the originator or reference product.
All biopharmaceutical medicines, including the reference product, are produced from living organisms and are therefore sensitive to manufacturing processes. Biosimilars are approved by the same regulatory authority utilising the same scientific rigour as is applied to their reference product. Prior to approval, they undergo rigorous analytical, pre-clinical, clinical and other testing, and substantial post-marketing studies are also required as a condition of approval.
Competition from biosimilar medicines increases patients' access to vitally important medicines by reducing their cost to the NHS. The development and use of biosimilars allows more patients to be treated for the same cost - a critically important issue when health budgets are limited and demand is increasing.
Because of their relative complexity and the resulting need for extensive development costs, biosimilars may not offer the same level of percentage price reductions compared to reference products as do some generic medicines. However, since the cost of most biopharmaceuticals is much greater than many conventional medicines, we expect that the total savings to the NHS will be considerable.
Further information on biosimilar medicines is available at the British Biosimilars Associaition website www.britishbiosimilars.co.uk .
Counterfeiting of medicines is a serious criminal act that puts people's lives at risk and is often part of organised crime. A counterfeit medicine can only reach a patient through community pharmacies if someone in the legitimate supply chain has done business with a criminal. So the most effective way of preventing counterfeiting of medicines is to ensure the integrity of the medicines supply chain through all parties doing business with certified partners only and exercising appropriate levels of due diligence.
Technical features as being proposed by the European Commission (such as mass serialisation, seals, or other similar features) do not stop criminal behaviour such as counterfeiting. They can only be seen as secondary lines of defence potentially helping to trace identified counterfeit medicines, and may give a false sense of security. They should therefore only be applied compulsorily to products at high risk of counterfeiting as required by European legislation and where they could be cost-effective.
Unsurprisingly, counterfeiters focus their efforts on high priced branded products and not generics. Though we are not complacent, we note that no counterfeit generic medicine has been discovered in the European Union.
Making sure medicines reach patients in a timely and efficient manner is another key advantage of the generics industry. Competition means that when a drug becomes off-patent several companies are able to supply alternatives which not only drives down the price but also means shortages are much more unlikely as manufacture will come from several different sources.
When a company has exclusivity over a branded drug shortages are much more likely to occur. Wholesaler data shows that orders for generics are met at a vastly superior rate at the first time of asking compared with brands.
Generic manufacturers and suppliers have freedom of pricing in the UK, with the Government relying on competition to keep prices low. The Government only intervenes in pricing if competition can be seen not to be working. The very competitive environment in the UK means that manufacturers' ex-factory prices are amongst the lowest in Europe. We believe that they are now so low that some increases will be necessary to create an economically sustainable market for manufacturers and to ensure that they can sustain the investment needed to produce new more complex generics and more costly biosimilar medicines.
Many European countries determine the cost of their generic medicines through centralised tendering and other centralised mechanisms. However, over a number of years, and particularly around 2002, the BGMA has worked with UK government to ensure that this has not become the case in the UK. The Association continues to make the case against centralised tendering in primary care. Our competitive system has led to a vibrant multi-source market, minimising the scope for shortages and delivering the lowest market prices in Europe.
The following reports review the generic medicines market in the UK and its contribution to reducing NHS costs.
OECD - Health at a Glance: Europe 2016 - How does the United Kingdom compare?
In 2016, the OECD published a report (Health at a Glance: Europe 2016) which stated that the development of generic medicines markets across Europe has provided a good opportunity to increase efficiency in pharmaceutical spending. It stated that generics accounted for 84% of the volume of pharmaceuticals sold in the UK in 2014 - the highest among EU countries - but that this represented only around a third of the total market value. The OECD’s specific UK findings can be found here.
NERA - Manufacture, distribution and reimbursement of generic medicines in the UK
A 2001 report conducted by economic consultancy NERA into the manufacture, distribution and reimbursement of generic medicines in the UK reviewed the effectiveness of the freedom of pricing system, as well as alternative pricing and reimbursement systems. NERA’s analysis highlighted the benefits of a reimbursement system based on market prices (not list prices) fixed by competition in preference to other alternatives such as tendering, reference pricing, profit controls or direct price controls. Following the report, the Department of Health implemented a reimbursement system based on market prices – which helped realise more savings for the taxpayer and supported widened patient access to medicines. The report can be found here.
When a drug becomes off-patent, competition from generic manufacturers is a very efficient way of driving down prices and increasing savings potential for the NHS as well as delivering innovation through offering competition to patent expired brands. However, there can be a number of barriers which prevent generic competition. As an industry, we face risks to our ability to launch at patent expiry due to activities of the originator sector some of which may be characterised as unfair competition. These include the abuse of patents. A European Commission Sector Inquiry report from 2009 said that applications to the European Patent Office (EPO) nearly doubled between 2000 and 2007.
The Commission acknowledged that the increase was partly due to 'defensive patent strategies' with the objective of 'delaying or blocking entry of generic medicines'. This included the use of patent clusters or thickets where multiple applications were filed around a single product in order to confuse actual current patent status.
We are concerned that the use of patent, or similar extensions of exclusivity, by legislators to drive industry behaviour can backfire. An example is the so-called “paediatric extension” which grants six months additional exclusivity in return for carrying out a paediatric investigation plan. These additional periods of exclusivity can cost the NHS enormous amounts of money when the actual number of new beneficiaries may be small in comparison and the research relatively low-cost.
We believe it is morally right that paediatric uses of medicines should be researched and licensed. We do not object to there being a financial incentive, if one is needed, to encourage companies to do this work. However, it just seems that high returns on such comparatively low investment are beyond all reasonable scale and proportionality.
Making medicines more affordable to the NHS and therefore increasing patient access to important, and potentially life-saving, drugs is a key role of the generics industry in the UK. Currently, the NHS is facing major funding challenges due to increased demand from an ageing population, rising cost of new technologies and drugs, as well as the need to increase efficiency through the QIPP agenda.
Generic competition already saves the NHS £13bn a year and allows further investment in new drugs which can support unmet patient need. We firmly believe there is a moral imperative on all of us in the industry, in the supply chain and the Government to ensure that generics are used to the maximum extent as it ultimately unleashes savings which increases patient access to vital medicines.
To improve consistent information to patients and significantly reduce the prohibitive cost of each company user-testing every single patient information leaflet (PIL) - at a cost per test in the region of £10,000 - the BGMAS supported co-ordination of user testing of PILs which can be of significant benefit to patients, industry, regulators and the NHS.
The BGMA has worked extensively with the Medicines and Healthcare products Regulatory Agency (MHRA) and through an innovative implementation plan we have delivered leadership in improving information to patients about their medicines.
BGMA members also have a strong commitment to ensuring their packaging meets patient needs and compliance and have been congratulated by the previous National Patient Safety Agency (NPSA) on leading improvements in this area.
The UK has the lowest market prices in the developed world for generics medicines as well as a high-cost, high-quality labour market. However, while generic competition has been enormously successfully as a means for saving money for the NHS, there has to be a limit to how far manufacturers can keep reducing prices because of strong competitive pressure. Generics operate solely at their own risk in terms of pricing. The Pharmaceutical Price Regulation Scheme (PPRS) gives branded medicines a risk sharing arrangement which allows them to modulate prices if they are too low. Generics do not enjoy this benefit.
The long-term sustainability of the generic medicines sector relies on fair prices and a level playing field, particularly in competition with branded medicines, including originators. A successful generic medicines policy requires both supply-side measures relating to pricing and reimbursement, and demand-side incentives for physicians, pharmacists and patients.
We work with the NHS to develop guidance that will ensure a more efficient NHS across the UK, whether this is on helping to resolve situations when a supplier is out of stock, or to ensure that all parties are aware of their rights and responsibilities when the NHS is developing new care and pharmacy models.
Standardised management of off-contract claims guidance:
Where a contracted supplier is out of stock and it cannot arrange for an alternative supply to be provided, an NHS trust or health board may charge for the difference between the contract price and what it paid for the replacement stock.
BGMA and ABPI have worked with both the NHS and NHS Scotland to develop practical guidance for English hospital trusts and Scottish boards to help hospitals efficiently make claims when off-patent medicines are out of stock; and for suppliers to process claims efficiently. This saves time and money for both hospitals and suppliers. In some cases, following the guidance may enable medicines to be located in the supply chain so as to resolve out of stock situations. The guidance documents applying to both England and Scotland can be located here: (England) / (Scotland).
Guidance around third party pharmacy provider arrangements:
The Department of Health has issued guidance to NHS trusts about what they need to consider and put in place when establishing and running agreements with third party pharmacy providers to operate hospital outpatient dispensing or homecare services.
The DH guidance outlines that NHS trusts must request and receive written permission from contracted suppliers before sharing confidential pricing data with third party pharmacy providers; and that permission should not be assumed. The guidance goes onto list the rights and responsibilities of trusts, third party pharmacy providers and suppliers. This includes third party pharmacy providers separating their hospital and primary care operations and being able to demonstrate this; as well as reporting accurate dispensing data to CMU, thereby supporting future forecasting used for medicines tenders. The DH guidance can be located here.