Medicinal Labelling Bill [HL]

Baroness Jolly Excerpts

Friday 25th October 2013 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I congratulate the noble Lord, Lord Winston, on securing a Bill that draws attention to the important information contained on the labelling and packaging of medicines. I need to reassure him that, although the noble Earl, Lord Howe, is not here, he and I were exchanging e-mails late last night as to the content of this speech. He is here in spirit if not in person.

The noble Lord’s reputation as one of the world’s foremost medical scientists is acknowledged both in academia and in the nation’s sitting rooms. I was fascinated by his contribution today. He recognises that the importance of information which accompanies medicine is all too often underestimated, so I am grateful to him for providing the opportunity to highlight this important subject and for finding the time to talk to me yesterday about the issue. As noble Lords would expect from the contributors to the debate, it has been commendable in terms not only of standard but of breadth and depth, for which I am grateful.

I should start by making clear that the Government’s commitment to a continuing need for properly regulated and ethically conducted research using animals where no practicable alternative exists is strong. The coalition agreement included a commitment to work to reduce the use of animals in scientific research. We believe that scientific advances present significant opportunity. All noble Lords have mentioned the three Rs: replace, reduce and refine.

To this end, we are pressing ahead with a delivery plan to work towards reducing the use of animals in research which has three strands: a domestic programme, an international programme and a programme to promote understanding and awareness about the use of animals where no alternative exists. This last strand would therefore seem to be entirely aligned with the aims of the noble Lord, Lord Winston.

Central to the Government’s work on openness and transparency is the review of Section 24 of the Animals (Scientific Procedures) Act 1986. This provides for the protection of confidential information provided in connection with regulatory activities. A breach of Section 24 can result in criminal sanctions. The requirements of Section 24 are now completely out of step with our policy on openness and transparency, and with the approach taken in other legislation such as the Freedom of Information Act 2000. The solution we develop will improve the overall transparency surrounding research using animals while protecting personal identities, intellectual property and commercial competitiveness. The principle is of fundamental importance to the life sciences sector; we have heard this today. Factors such as the rapid pace of global travel, the looming threat of widespread antimicrobial resistance and an increasingly ageing world population all present challenges in dealing with many conditions which noble Lords have mentioned today.

Improved research models will be required to deal with these challenges, and animal research will play a vital role in their delivery. To retain public confidence in our work we must be open and transparent about our use of animals. In relation to the labelling of medicines, the House might find it helpful if I explain the rationale for requirements for information which accompanies medicines, particularly labelling, and the legislation which pertains to these requirements. The label on the medicine, along with the packaging and the product information are the public face of the product. The law governing the labelling of medicines is set out in European law, in title 5 of council directive 2001/83/EC, which specifies what information must appear on the label. This is replicated within Part 13 of the Human Medicines Regulations 2012, which recast the Medicines Act 1968. This European and national framework requires that some 14 items of information must appear on what are often small packages, already crowded. The legislation also states that where the information provided complies with the requirements, member states cannot refuse to authorise such packaging. A statement on animal research is not currently required as part of the information set.

The primary purpose of the medicine label is to identify unambiguously the product and to alert users to any important safety messages. Clear labelling ensures that healthcare professionals and patients can select and use medicines safely and to best effect. Although no particular size of text is specified in legislation as regards information on the label, the European Commission has published guidance which recommends text of a size not smaller than 7-point. Those of us who are ageing will appreciate that, but also note that they often miss it by a mile.

Many pharmaceutical companies struggle with three considerations: legibility of information on the packaging; keeping packaging to a minimum; and supplying packs which are easy to read. Increasing the amount of information which is required to appear on the label and the packaging is likely to have a detrimental effect on text size. This would result in all the information appearing in a smaller text size on the package, having a negative impact on users’ ability to find and assimilate key messages. In high-pressure environments such as pharmacies, this could make safe selection of the correct medicine difficult to carry out quickly.

I certainly have a personal anecdote about this. A pharmacist was unable to read clearly the different labels on two medicines that were side by side on the counter. My mother was not given the medicine prescribed for her but the neighbouring one, and as a consequence she was very poorly for a very long time. Of course, more information can be and is accommodated within the patient information leaflet that comes in the packaging of all medicines. However, again, the legislation covering those does not specify the need to include anything about whether the product or its ingredients have been subject to animal research. The focus here is safe and effective use of the product to help patients manage their disease. Where the patient information meets the legislative provisions, national competent authorities in the UK and the Medicines and Healthcare products Regulatory Agency cannot refuse to accept these.

On the key issue of European medicines licensing, there are more fundamental points at issue here than the problem of adding more material to the packaging of medicines. These are to do with the way we regulate medicines to safeguard public health. More and more medicines are now authorised through European licensing procedures. These arrangements enable a pharmaceutical company to market a product in all member states across the Community. As part of this licensing arrangement, the labelling and product information, which is approved, must be identical across the Community. This leaves no opportunity for the United Kingdom to require specific labelling statements concerning animal testing to appear. Therefore the UK is not able to act unilaterally in seeking to add new labelling requirements in an area covered by EU legislation—which is a key point. Legislative obstacles to the inclusion of this information were previously explored at European level, but proposals in this area were rejected.

At a meeting of the Pharmaceutical Committee, the European Commission’s senior pharmaceutical policy body, the UK sought clarification of the labelling provisions. The outcome was that there should be no additions to the labelling spec. Any additional information on the label included even that added voluntarily by pharmaceutical companies, and is unlikely to be acceptable. Indeed, such a voluntary arrangement could not be enforced, and a level playing field could not be ensured. This could cause confusion and uncertainty to patients and healthcare professionals alike.

Let us take into consideration the patient. Including a statement about animal testing on medicines labelling could impact adversely on patient compliance and health outcomes. Prescribers must weigh up the fine balance between the possibility of benefit from a particular medicine against any possibility of harm. The inclusion of a statement about animal testing could inadvertently shift this balance and would require additional explanation. Doctors, pharmacists, nurses and other healthcare professionals might see a significant impact on their workload, as they would need to take time to explain and reassure patients about the safety of the medicine and their rationale for prescribing a product.

A further difficulty in ensuring compliance with such a legal responsibility would be to define the extent of animal research that would require relevant labelling. It is likely that all medicines currently on the UK market will have one or more ingredient that has at some point in its development been the subject of animal research. This begs the question of how to make any such requirement meaningful, whether a timescale or threshold should be used, or a proportion of the active ingredient and/or any excipients. That challenge is likely to make the framing of any such requirement extremely difficult. In conclusion, I am grateful to the noble Lord for raising the issue, and to those noble Lords who spoke so thoughtfully in today’s Second Reading debate.

I will respond to questions from noble Lords. The noble Lord, Lord Willis, raised the issue of Department of Health funding of research. As the noble Lord will know, BIS funds annual research, but the National Institute of Healthcare Research, which is in fact an arm’s-length body of the Department of Health, builds upon that initial research, and the Department of Health is fully supportive of this. The noble Baroness, Lady Wheeler, asked about guidance on packaging and labelling. The MHRA guidance on packaging and labelling is updated regularly to reflect the latest research and learning on how the risks and benefits of medicines are communicated.

While I share the view that it is important to explain the need for and the value of research on animals and what the Government are doing to play their part, I cannot share the view that the labelling of medicines is the right vehicle to achieve those ends. The legislation on medicines labelling, which is European in origin, does not require such a statement. The UK cannot act alone in the area of medicines labelling. The potential for a statement about animal testing causing worry to patients and resulting in them failing to take their medicines as intended could lead to treatment failure and disease progression. For these reasons the Government cannot support the Bill. However, I sincerely hope that noble Lords may find a way to help the Government’s programme to promote a national understanding and awareness of the use of animals in testing where no such alternatives exist.