Emergency contraception was made available without prescription in Ireland in 2011. This has been a welcome step in terms of improving reproductive freedom. Nonetheless, barriers to access continue to exist. This document, written by working group Re(al)-Productive Health, aiming to improve access to reproductive resources in Ireland, includes consultation with organisations such as Abortion Rights Campaign, The Y Factor, the Irish Family Planning Association, Doctors For Choice Ireland, Union of Students in Ireland (USI) , ROSA - for Reproductive rights, against Oppression, Sexism and Austerity and the Irish Feminist Network-features tangible proposals specifically regarding: - improving access to emergency contraception in Ireland - the methods by which this can be achieved - analysis of the status and accessibility of emergency contraception in other countries.
Emergency contraception was made available without prescription in Ireland in 2011. This has been a welcome step in terms of improving reproductive freedom. Nonetheless, barriers to access continue to exist. This document, written by working group Re(al)-Productive Health, aiming to improve access to reproductive resources in Ireland, includes consultation with organisations such as Abortion Rights Campaign, The Y Factor, the Irish Family Planning Association, Doctors For Choice Ireland, Union of Students in Ireland (USI) , ROSA - for Reproductive rights, against Oppression, Sexism and Austerity and the Irish Feminist Network-features tangible proposals specifically regarding: - improving access to emergency contraception in Ireland - the methods by which this can be achieved - analysis of the status and accessibility of emergency contraception in other countries.
Emergency contraception was made available without prescription in Ireland in 2011. This has been a welcome step in terms of improving reproductive freedom. Nonetheless, barriers to access continue to exist. This document, written by working group Re(al)-Productive Health, aiming to improve access to reproductive resources in Ireland, includes consultation with organisations such as Abortion Rights Campaign, The Y Factor, the Irish Family Planning Association, Doctors For Choice Ireland, Union of Students in Ireland (USI) , ROSA - for Reproductive rights, against Oppression, Sexism and Austerity and the Irish Feminist Network-features tangible proposals specifically regarding: - improving access to emergency contraception in Ireland - the methods by which this can be achieved - analysis of the status and accessibility of emergency contraception in other countries.
Improving access to non-prescription emergency contraception in Ireland
Re(al)-Productive Health
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Acknowledgements
Re(al)-Productive Health would like to acknowledge with deep gratitude the financial support from XMinY who made the publication of this document possible. We would also like to extend a warm thank you to the groups, individuals and organisations which consulted on and contributed to this document, including; The Abortion Rights Campaign, The Irish Family Planning Association, ROSA, The Y Factor, Doctors for Choice, The Union of Students in Ireland and The Irish Feminist Network.
Re(al)-Productive Health would like in particular, to pen our appreciation for the assistance with the launch of our campaign which we received from Ursula Barry and Leslie Sherlock.
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 2
INTRODUCTION 4
CURRENT PROPOSALS/ANALYSIS 6 SUMMARY 6 IN DETAIL 7
SETTING A MAXIMUM COST . 7 ALTERATION OF THE ACCESS PROCESS...12 ADVANCE PROVISION OF EC.................................................... 21 REGULATED ROTA SYSTEM... 22 SPECIALISED TRAINING OF PHARMACISTS AND PHARMACY PROFESSIONALS. 24 REMOVING THE CONSCIENTIOUS OBJECTION CLAUSE 26 CLARITY ON AGE LIMITS.30 CLARITY ON GENDER AND SEX..32
HUMAN RIGHTS CONTEXT 33
COST 36 CONSCIENTIOUS OBJECTION/ROTA SYSTEM...37
CONCLUSION 41
REFERENCES 42
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INTRODUCTION
In April 2011, emergency hormonal contraception, levonorgestrel, (available in Ireland as HRA Pharma's 'NorLevo'), became available behind-the-counter without prescription in pharmacies in Ireland. In other words, subsequent to a consultation process, emergency contraception can now be accessed in pharmacies, as opposed to requiring a prescription from a GP. It was something that we had wanted. Indeed, according to a recent study conducted by the Irish Pharmacy Union, the only brand of levonorgestrel available thus far, NorLevo, has been requested in 85% of pharmacies in Ireland since its launch (IPU, 2013). In terms of increasing reproductive and sexual freedom, its certainly a step in the right direction. However, what Re(al)-Productive Health are asking, is whether over two years later, we have truly progressed in securing full reproductive and sexual rights in Ireland. Re(al)-Productive Health, launched in September 2013, seeks to provide a platform for debate and discussion on issues relating to emergency contraception and to reproductive and sexual health rights generally in Ireland. The initiative also seeks to effect tangible change in terms of altering guidelines and processes surrounding provision of emergency contraception, in order to allow for greater accessibility and to reduce stigma around the issues of female sexuality in Ireland. The website features a facility whereby experiences of access of emergency contraception in pharmacies can be uploaded onto a map of Ireland. This feature aims to both highlight issues relating to access, alongside allowing individuals an opportunity to seek out availability and accessibility of the drug in their local area. Also featured on the website are detailed accounts of interaction with pharmacists in seeking to access emergency contraception, helpful tips on how to practically access the drug and what to expect, alongside contributions from writers on the topic of female reproductive health more generally.
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We believe the securing of improved availability and access to the morning after pill in Ireland to be hugely significant in terms of procuring and retaining those real reproductive rights which have often been overlooked. Now is the time for all genders in Ireland to assess and seek to improve all arenas of reproductive and sexual freedom. Re(al)- Productive Health feel this can be effected in a tangible, productive way. Re(al)-Productive Health wish to continue the fight for reproductive rights - to learn from real experiences and demand real action. Detailed within this submission are our current proposals and analysis regarding improving access to levonorgestrel behind-the-counter without prescription in pharmacies.
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CURRENT PROPOSALS: A SUMMARY
- SETTING A MAXIMUM COST
- ALTERATION OF THE ACCESS PROCESS - BTC to OTC, ALTERATION OF THE CONSULTATION PROCESS
- ADVANCE PROVISION OF EMERGENCY CONTRACEPTION
- REGULATED SUNDAY ROTA SYSTEM FOR PHARMACIES
- SPECIALISED TRAINING OF PHARMACISTS AND PHARMACY PROFESSIONALS
- REMOVING THE CONSCIENTIOUS OBJECTION CLAUSE
- CLARITY ON AGE LIMITS
- CLARITY ON GENDER AND SEX
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CURRENT PROPOSALS / ANALYSIS - IN DETAIL
SETTING A MAXIMUM COST Setting a standard maximum cost of 9.99-15.00 for emergency contraception Emergency contraception to be available free to medical card holders without prescription.
In her words: ...the price 35 was very expensive, should I have needed it, I thought it might be a hindrance to people who didnt have the money, they might be more likely to risk it and not take it. Was told it was 60 in Hickeys and couldn't afford it, this was when the pill very first came out We feel that, as a reproductive right, access to emergency contraception should be free - socially subsidised. As a short term goal, however, we feel the setting of a maximum, standard cost of the drug would be preferable, in terms of accessibility, than the current, unregulated system, alongside free access to the drug for medical card holders. In light of the continuation of an extremely harsh economic climate in Ireland, such a goal is especially important. With cuts to the job seekers allowance for under 25 year olds in Budget 2014, for example, it is simply impermissible to allow financial constraints to impede peoples right to contraception.
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Standard price (a) The cost of the morning after pill is unregulated and varies hugely from 9.99 to 45 or more. Over 21% of our survey respondents had paid between 30-35 for NorLevo, 20% had paid between 15-20 while just over 15% had paid between 25-30. Worryingly, 17% of respondents had paid more than 35 for the pill, with just 11% having paid less than 15. It was reported in 2011 that the availability of NorLevo without prescription in Ireland would cut the cost of the drug to 9.99. However, any attempts of Re(al)-Productive Health to establish the cost price of NorLevo through the manufacturer of the product, HRA Pharma, have proven unsuccessful. The Irish Family Planning Association have stated that the cost of accessing the morning after pill has been an increasing cause of complaint particularly since 2010 (IFPA, 21/01/2012). The price of emergency contraception is significantly lower in many other countries. In Portugal, for example, the drug levonorgestrel (NorLevo) is free when procured from family planning centres at primary health care services and hospitals associated with the National Health Service. In the UK, the cost of emergency contraception is just under 7, while in Belgium the morning after pill can be bought for under 12 (International Consortium for Emergency Contraception, 2013). We feel it to be essential that a standard, maximum price be set for the morning after pill, so that individuals are aware of how much the drug will cost them irrespective of where they live. Access to emergency contraception is our reproductive right: our economic resources should not influence our access to it. Levonorgestrel is a drug which must be taken within a very short time frame, and so financial alternatives such as borrowing from a friend, accessing post office/credit union or other savings accounts are not always an option. Furthermore, depending on the age range, living situation and refugee status of individuals, access to money may be greatly constrained. Over 88% of our survey respondents agreed that a standard, maximum price should be set for emergency contraception in Ireland.
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Without being able to establish the exact cost price of NorLevo in Ireland, it is difficult to identify a price for the drug which would both cover the cost of the drug to the pharmacy and be considered fair to those requiring this time-sensitive medication. With the drug no longer requiring a PGD (Patient Group Direction) prescription, and thus no longer requiring a dispensing fee, we suggest the setting of a standard price between 9.99-15, reflecting the average cost of regular oral contraceptives, would represent a positive start in terms of rendering emergency contraception more accessible in Irish pharmacies. We thus call on the Department of Health to make an agreement, as is implemented with prescription drugs, with manufacturer HRA Pharma regarding the cost of NorLevo to pharmacies, as well as instate a maximum price of the drug to patients. Inclusion within the medical card scheme (b) Levonorgestrel, when provided for by a doctors prescription, is included within the medical card scheme. However, the lack of inclusion of non-prescription emergency hormonal contraception under the Irish medical card scheme is very concerning. In other words, within the current situation, though reimbursed for emergency hormonal contraception when accessing it with a prescription in pharmacies, patients are not reimbursed when accessing emergency contraception without a prescription. With a recent survey conducted by the Irish Pharmacy Union indicating that 18% of respondents with a medical card chose to get their emergency contraception from a pharmacy as opposed to getting it free on prescription from their GP, the issue certainly requires resolution. With seasonal flu vaccinations, among many other drugs, available free of charge in pharmacies under the medical card, it is difficult to understand why there exists such a difference in terms of provision of emergency hormonal contraception. The IPU have already called for action on this. Re(al)-Productive Health are in full agreement with such a position it is time to place public pressure on the HSE to include non-prescription emergency hormonal contraception within the medical card scheme. Indeed, over 88% of respondents in our survey agreed that inclusion of over-the-counter emergency contraception for medical card holders is necessary.
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Wouldnt lowering the cost would encourage people to be more promiscuous, or to take more risks? Levonorgestrel is a legal drug in Ireland. As with any other legal medication, Re(al)- Productive Health feel it should never be refused or restricted based on the moral judgements of any other person. It is an individuals choice to access the morning after pill, once that decision is the individuals consensual and informed choice and there are no medical reasons to avoid taking it, (and if any, the individual is willing to take any potential risks involved), the individuals own judgement is the only one that matters. The decision to prevent a potential pregnancy (in medical terms) renders the reasons surrounding that choice irrelevant to assessing the drug and subsequently, the price of that drug. In other words, such a decision should never be impeded by access or cost-issues. Emergency contraception can prevent unwanted pregnancies and this is for this reason that it is used. In both social and economic terms, it would be nonsensical to force someone who could not afford the drug to instead endure a crisis pregnancy, on the premise that they should be punished for being sexually active, which, likewise, is an individual choice. Dont pharmacies need to make money too? How could they afford to lower the price of drugs in such a difficult economic climate?
Health care is a human right, as articulated in many human rights charters such as the Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights. Economic factors should never impede a persons right to access healthcare. Re(al)-Productive Health believe that essential medication such as emergency contraception should be socially subsidised through taxes - but free at the point of access. As a short term goal, however, we feel that a standard maximum price set between 9.99-15.00 would render the drug more accessible to those who requiring it within a short time-frame. Considering the drug no longer requires a prescription, and thus no longer requires a dispensing fee, a price of 9.99-15 would reflect the average price of regular contraception, viable for pharmacies in terms of cost. Such a price would seem vastly more equitable. The social and economic costs for both the individual and the state of a crisis pregnancy can be significant and as such it would be economically nonsensical to potentially create unwanted pregnancies by impeding access to emergency contraception.
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ALTERATION OF THE ACCESS PROCESS; BTC to OTC, ALTERATION OF THE CONSULTATION PROCESS
Information Giving Non-Judgemental Standardised/Consistent A process of informing - not impeding
In her words:
...I filled in the form in about 5 minutes, but it was at least another 20 before anyone came back into the room...Finally, a pharmacist came back into the room and went through the whole form with me again. Then she asked a question I was not expecting: How did this happen?...The pharmacist asked me if I wanted to learn about more safe methods of contraception, such as the pill and condoms. I wanted to shout at her that I wasnt an idiot and I just made a stupid mistake, and why wasnt he being offered a lecture about contraception? But I just said no. Finally, feeling humiliated and about 40 minutes after entering the pharmacy, I was able to buy the pill. ...I had to do an "interview" of sorts with the pharmacist first, but was then given it if all of my answers were acceptable.
Behind-the-counter to over-the-counter
Currently, and since 2011, access to emergency contraception (levonorgestrel or NorLevo) without prescription in Ireland is available in a BTC (behind-the-counter) process. In other words, emergency contraception must be requested from a pharmacist. Those seeking the drug cannot simply pick it up from a pharmacy shelf and pay for it. However, in order to wholly remove barriers to emergency contraception, Re(al)- Productive Health feel emergency contraception should be truly available OTC (over-the- counter). In other words, a decision to use emergency contraception should not be determined by the judgement of the pharmacist, but instead by the informed judgement of the individual seeking the drug.
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According to the recently updated, (December 2013), PSI (Pharmaceutical Society of Ireland) guidance on the supply of levonorgestrel NorLevo by pharmacists, the supply of Norlevo1.5mg tablets should only be made personally by a pharmacist following a structured, documented consultation with the patient and that Each time this medicine is supplied the pharmacist must be satisfied that, in the exercise of his or her professional judgment, the supply of such a medicine is safe and appropriate for the individual patient. It is also stated that Consultations between the pharmacist and the patient should take place in the pharmacys patient consultation area (PSI, 2013).
Boots were the first chain of pharmacies to provide Norlevo without a doctors prescription, dispensed through a process of PGD (Patient Group Direction). This process, a written direction relating to the supply and or administration of a prescription only medicine and is developed, authorised and signed by the Boots Medical Director (Medical Independent, 2010), required a consultation between the pharmacist and the patient. Upon the approval by Irish Medicines Board of over the sale of the drug without a doctors prescription for all pharmacies however, pharmacies were in a position to sell Norlevo without the PGD. The question thus arises; why are such not strictly defined consultations still considered by the PSI (Pharmaceutical Society of Ireland) to be a necessary requirement of access the drug in Irish pharmacies? The continuation of such a consultation process associated with NorLevo is well- documented in practice, with 91% of our survey respondents required to go through a process of consultation with a pharmacist before gaining access to the drug. Such a process is certainly useful in terms of providing those seeking it with comprehensive information on the potential risks and effects associated with the drug. Nonetheless, with the consultation largely based on a questioning approach regarding the contraindications and appropriateness of the drug in order for the pharmacist to determine whether access will be given or not, it may represent a source of intimidation, frustration or embarrassment for many patients. 23% of the respondents in our survey identified the consultation process as negative and 28% of respondents felt that the pharmacist involved displayed some negative judgement towards them, with terms such as patronising,
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embarrassing, awkward, unnecessary and the statement I felt judged used by some participants. Thus, in order to provide accurate, comprehensive information on NorLevo, whilst also acknowledging the potentiality of such negative emotions, the availability of emergency contraception over-the-counter, with an optional information giving approach would perhaps be more appropriate. In other words, pharmacists should be more focused upon briefly informing an individual seeking the drug, if this individual wishes, of the nature of the drug, using a standardised and consistent list of statements, as well as providing an information leaflet, as opposed to the present quasi-gate-keeper approach, with the ultimate decision regarding access, on the basis of current PSU guidance, lying with the pharmacist. Indeed, NorLevo is widely regarded as safer than Aspirin (Grimes, 2002: 1536), with the U.S. Centers for Disease Control and Prevention Medical Eligibility Criteria for Contraceptive Use (MEC) stating there are no circumstances where the risks of levonorgestrel EC outweigh the benefits, including conditions in which combined oral contraceptives are contraindicated (Rafie et al., 2013: 553). Levonorgestrel does not disrupt an already established (implanted) pregnancy, has no clinically relevant drug interactions, no increased risk of ectopic pregnancies, and no effect on future fertility, no known abuse or dependence potential, is not a known allergen and is not causally linked to any serious complications, including venous thromboembolism or death (Rafie et al., 2013: 553). It is therefore difficult to see why there exists such a variation in the process of access between levonorgestrel and other, more dangerous drugs such as aspirin, as well as other drugs such as antihistamines (Zirtek) and dextromethorphan (cough suppressants such as Vicks NyQuil) (Rafie et al., 2013: 553). Indeed, we would agree with the International Consortium for Emergency Contraceptions assertion that similar to such drugs, Permitting ECPs to be purchased at a large number of retail outlets with expanded hours would greatly increase accessibility (ICEC, 2013: 3). It is important to note that Re(al)-Productive Health are by no means inherently opposed to the notion of a consultation process. However, on the basis of our research, it is our view that consultations should instead, as stated above, take the shape of an optional,
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information-giving, standardised and consistent interaction between the patient and the pharmacist. Thus, we feel the focus should lie in ensuring the individual themselves are satisfied that they are fully informed on the drug, not on ensuring that pharmacists are satisfied that individuals are fully informed and that the supply of such a medicine is safe and appropriate for the individual patient. (PSI, 2013). Indeed, those who have already taken the drug on a previous occasion, and/or who feel informed regarding any issues relating to the drug they feel concerns their particular situation, should not be forced to engage in any interaction with the pharmacist regarding the use of the drug. For example, a simple statement at the point of sale Would you like me to run through the contraindications associated with the drug and its method of use?, would perhaps suffice in terms of allowing patients the opportunity to inform themselves fully of the effects of the drug. We suggest that those seeking the drug are however always provided with already published information materials produced by HRA Pharma, the Crisis Pregnancy Programme and the IPU. We also feel patients should have the option to ask questions either in the main pharmacy area, or in a private consultation area, if they so wish. In summary, the provision of an optional and free information-giving consultation for first- time users or those who feel uninformed regarding the nature of the drug, following a standardised medical focus, would perhaps better allow for a non-judgemental and consistent procedure in terms of dispensing levonorgestrel in Irish pharmacies. Ultimately and most importantly, we feel access to the drug should not be decided by the pharmacist. If someone feels, on the basis of either prior knowledge or experience, or on the basis the provision of information by a pharmacist, fully informed on the nature of the drug, a decision to take any risks involved should always remain autonomous.
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How would one go about changing the current process? The insistence upon behind-the-counter, as opposed to over-the-counter access is directly linked to the legal status of the drug. Indeed, at present, NorLevo is licensed by the Irish Medicines Board for Pharmacy Only use, which means the drug must be stored in a professional services area of the pharmacy and not in the general body of stock (PSI, 2008: 27). Thus rendering the drug truly over-the-counter, would require a change in the status of NorLevo to General Sales status. Though NorLevo has only been classified as Pharmacy Only since 2011, such a change is a possibility. Indeed, according to the Irish Medicines Boards guide to the reclassification of human medicines, though Generally products should have 5 years post authorisation safety data available for review including data from all relevant patient populations in order to be considered for review applications for products that are recently authorised or with limited exposure may be considered provided the clinical expert report should clearly lay out and justify the rationale for such a request (Irish Medicines Board, 2010: 8).
Indeed, it is important to examine statutory regulations within the Regulation of Retail Pharmacy Business Regulations 2008, regarding the supply of medicinal products other than on foot of a prescription which states that; A person carrying on a retail pharmacy business, the superintendent pharmacist and the supervising pharmacist shall ensure that, in the course of the sale or supply of a medicinal product other than on foot of a prescription and prior to such sale or supply, a registered pharmacist is satisfied that the purchaser or other such person is aware of what the appropriate use of the medicinal product is and that it is being sought for that purpose and, in so far as the registered pharmacist is aware, the product is not intended for abuse and/or misuse. Re(al)-Productive Health is in full agreement with the statement that a registered pharmacist be satisfied that the purchaser or other such person is aware of what the appropriate use of the medicinal product. Patients need, as with all other drugs, to be provided with comprehensive information on any medication they seek to use. The statement, however, that the drug be sought for that purpose, and not be intended for
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abuse and/or misuse, is perhaps concerning, suggesting that patients may not possess full autonomy over their own, informed choices regarding their use of this medication. Certainly, the use of levonorgestrel, for example, in order to conceal the potential consequences of sexual assault, would be reprehensible. Nonetheless, it should be asked if the realm of healthcare be the ideal in terms of attempts to prevent such a risk. In other words, should the accounting for such a risk lie at the expense of potential intimidation? In addition, there exists quite a large scope in terms of the taking out of context of terms such as abuse and misuse. In one pharmacists eyes, abuse could encompass the possibility of the use of levonorgestrel on a number of occasions. On the basis of a presupposed value or acceptance of individual autonomy the using of the drug in such a manner could never be considered abuse. Thus, and importantly, the recorded safety of the drug and evident lack of potential for abuse and misuse would appear to render the current legal status as Pharmacy Only, the classification of drug it would appear the Regulation of Retail Pharmacy Business Regulations 2008 refers to here (i.e. it would not appear that these regulations encompass General Access drugs), as open to challenge and alteration. In specific terms of the mandatory taking place of the consultation within the patient consultation area, Regulation 4 (3) of the Retail Pharmacy Businesses Regulations 2008 also states that the provision of a separate and designated area conveniently located within the pharmacy premises so that a pharmacist may review and discuss in private with the person for whom a prescription has been issued, or with the carer of such a person...as either of the said persons may request or as the pharmacist, in the exercise of his or her professional judgment, may deem necessary. Thus, according to regulation, the decision to consult with a patient in a patient consultation area can be at a pharmacists discretion, depending on the situation at hand. Adherence to such statutory law does thus not necessarily intend that it is mandatory that consultations for specific drugs take place within a patient consultation area, and thus the statement by the PSI that Consultations between the pharmacist and the patient should
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take place in the pharmacys patient consultation area (2013), is perhaps not a guideline that is necessary in terms of conforming to legal regulations, and thus could easily be altered or removed, in terms of rendering the decision to use the private consultation area to be solely that of the patients. It is also important to note that these guidelines refer only to prescription drugs. It is unclear from this statement what policy exists in relation to Pharmacy Only drugs. Again, we need only look at practice in relation to other BTC drugs for evidence of variance, at the very least, in reality. Aside from such questions and assertions, however, the essential must be highlighted - removal or alteration of such a mandatory consultation procedure within PSI guidelines would not, it would appear, on the basis of scrutiny of statutory regulations necessitate an alteration in statutory regulations. Taking the above points into consideration, we call on the PSI to consider our proposals regarding a dramatic alteration in the process of consultation regarding emergency contraception, as well as upon interested parties to consider initiating the process of reclassification of NorLevo from Pharmacy Only access to General Access, or in other words, from behind-the-counter to over-the-counter Consultation process in other countries Currently, 57 countries worldwide are in a position similar to Ireland, allowing access to EC from a pharmacist without requiring a prescription, or, in other words, access to EC where the direct intervention of a pharmacist is required (behind-the-counter); Australia, Austria, Azerbaijan, Belarus, Belgium, Benin , Burkina Faso, Cameroon, China, Congo, Republic of (Brazzaville), Dominican Republic, El Salvador, Ethiopia, Finland, France, Gabon, Ghana, Greece, Guinea-Conakry, Guyana, Iceland, Iran, Ireland, Israel, Ivory Coast, Jamaica, Kenya, Latvia, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mauritius, Mexico, Monaco, Mozambique, New Zealand, Niger, Nigeria, Pakistan, Serbia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, United States of America, Uruguay, Uzbekistan, Venezuela, Vietnam
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However, 15 countries allow direct access to EC over the counter; Bangladesh, Bulgaria, Canada, Cyprus, Denmark, Estonia, India, Laos, Netherlands, Norway, Portugal, Romania, Slovakia, Sweden, United States of America
Results from those countries allowing access to EC over the counter is very positive. Plan B (another brand of levonorgestrel) in Sweden, for example, has an established safety record with widespread evidence showing safe and effective use without professional intervention, (CMAJ, Erdman and Cook in Foster, Wynn., 2012: 75).
In addition, the benefits of intervention of a pharmacist are disputed, with a Canadian study finding that Pharmacist intervention...did not achieve its claimed benefits in practice, with little evidence that screening and consultation improved safe and effective use and Pharmacy practice found to be varied with no enforced standard, with the lack of a standardized screening form allowing individual pharmacists to decide what personal information to ask (Foster, Wynn, 2012: 75). Levonorgestrel was first made available in Canada behind-the-counter in 2005, but a National Association of Pharmacy Regulatory Authorities (NAPRA) ruling in 2008 gave the drug full over-the-counter access in most provinces.
A similar process occurred in the US, with the drug being given behind-the-counter status in 2006, and over-the-counter access in 2009.
Overall, studies on truly OTC access has shown that women of various backgrounds have been shown to use emergency contraception safely and appropriately when EC was provided OTC, with incidence of adverse effects and pregnancy rates being relatively low, (Nguyen, 2007: 13).
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ADVANCE PROVISION OF EC The World Health Organisation (WHO) state that advanced provision of emergency contraception is not associated with increased frequency of unprotected intercourse but rather leads to increased use of the method (WHO, 2010). Dr Stephanie OKeefe researcher and policy manager with the HSE crisis Pregnancy Programme has stated that taking the morning after pill does not impact on primary use of regular contraception (IFPA, 21/01/2012). Re(al)-Productive Health feel that providing access to advanced provision of emergency contraception in Ireland would give greater access and autonomy over reproductive health choices. Access to emergency contraception from home, from ones own medical storage would be undoubtedly beneficial to those requiring the time sensitive drug during anti-social hours or those with restricted access to finance. In line with our proposal of an alteration to the consultation process for those requiring immediate access to emergency contraception, we suggest a similar process in terms of advance provision; the provision of a standardized information leaflet, alongside an optional opportunity to consult with the pharmacist in a private setting. Advanced provision of the morning after pill is already available in many countries, such as Canada, Denmark, Sweden, Portugal and the United States of America (International Consortium for Emergency Contraception, 2013). In these countries, as already stated, the drug is available over the counter without having to go through a pharmacist. Just over 80% of respondents in our survey agreed with our proposal for the advanced provision of emergency contraception in pharmacies.
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REGULATED SUNDAY ROTA SYSTEM FOR PHARMACIES Accessing the morning after pill can be especially difficult for those living in rural areas where there may be just one pharmacy or where some travel is required to access a pharmacy in a nearby town. As such, access to and availability of the drug are particularly important in these cases. In order to ensure the availability in all chemists of the morning after pill, we must stress the importance of rural pharmacies operating a rota system on Sundays to ensure access to the drug on weekends. With such a short time frame required for effective use of the pill, it is not fair or in many cases possible to travel substantial distances in order to find an open pharmacy, which may, vitally, still conscientiously object to giving her the drug. Sunday rota systems already operate in many towns around Ireland, reflecting the unique importance of the services which pharmacies provide. However, Sunday opening hours of pharmacies are voluntary, and not regulated by law, and are instead subject to the contract between the pharmacy and the HSE, with the opening hours needing to be reasonable. Reasonable, in its typical form, however would take the form of weekday opening from 9 am - 6 pm, and Saturday opening from 9 am - 6 pm. The opening of a pharmacy for a few hours on a Sunday is not part of the contract (Vogler et al., 2006: 17). We propose that Sunday opening hours be written into the contract between pharmacy and HSE on a rotation basis, in all areas in Ireland, in order to ensure safe, effective and consistent access to the emergency contraception, as well as other similar time-sensitive drugs, within strictly defined geographical areas. 89% of participants were in agreement with us on this proposal.
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Countries where pharmacies operate a rota system, how it works: Many European countries provide legally enforced Sunday rota systems, in which pharmacies in particular areas must remain open. In Italy, for example, the rota system means the ensuring of an open pharmacy in each general area at night, holidays and Sundays, with each pharmacy displaying a card with its own opening hours, emergency telephone number, and where to go outside of those opening hours for emergency services. In Sweden as well, the Dutch Pharmacy Standard (Nederlandse Apotheek Norm, NAN), requires that pharmacies operate 24 hour delivery of pharmaceuticals to their customers, with pharmacies joining groups and providing service outside the normal opening hours on a rotation basis (Vogler et al., 2006: 32).
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SPECIALISED TRAINING OF PHARMACISTS AND PHARMACY PROFESSIONALS In addition, we also propose that pharmacists and pharmacy professionals may benefit from additional training, specifically in relation to supply of NorLevo. 96.25% of participants in our study agreed that it is essential To ensure pharmacists are properly trained to dispense emergency contraception in a non-judgemental, understanding manner. According to current PSI guidelines, Superintendent and supervising pharmacists must ensure that there is adequate staff training in place to ensure compliance with all of these policies. All pharmacists providing the service should be trained in these policies and procedures. All other staff in the pharmacy should be familiar with the policies of the pharmacy and should be appropriately trained in the relevant procedures (PSI, 2013). We would agree with such statements. However, in reality, it is difficult to ascertain how trained pharmacists and pharmacy professionals are with specific regard to emergency contraception. At present, the Irish Pharmacy Union offer a module on emergency contraception on IPU NET, a web based application. The IPU NET Emergency Contraception module is a clinical decision support tool designed to assist community pharmacists in providing safe and effective access to emergency hormonal contraception in a community pharmacy (Duggan, 2012). The IPU also offer a Distance Learning course on the topic. Such a facility may indeed be useful in educating pharmacists on provision of emergency contraception behind or over the counter. Nonetheless, a rather more comprehensive training programme would be welcome. Indeed, by way of comparison, in the UK, pharmacists must have completed three CPPE open learning/e-assessment packages, Emergency Contraception; Contraception; and Child Protection A Guide for the Pharmacy in order to be accredited for supply of levonorgestrel over the counter. The difference is, however, that online training is supplemented by two required training sessions (NHS, 2013: 4). Such training sessions may serve to deepen and consolidate information in a manner beyond the capacity of an online programme. Indeed, a study undertaken on a pilot training session in the UK in 2003 found such training to have been of great value to pharmacists, in terms of a team-building exercise, enabling the participants, the project manager and community trust pharmacists,
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and the clinicians who would be offering support to get to know each other and work as an effective unit (Bacon et al., 2003: 21) Similarly, in New Zealand, pharmacists must have successfully completed an education programme accredited by the Pharmacy Council and become accredited providers of emergency hormonal contraception (PSNZ, 2013: 1). Studies on training of pharmacists regarding levonorgestrel in Canada also revealed a significant difference in pharmacist knowledge before and after training (Neubauer in Foster, Wynn., 2012: 75) In order to reduce the stigma surrounding emergency contraception in Ireland, potential training sessions in Ireland could seek to, along with information on contraindications and reproductive health, focus upon improving the experiences of individuals in accessing emergency contraception. A focus on awareness of potential embarrassment and shame of those seeking to access NorLevo, awareness on the positive and negative impact of aspects such as body language and language, as well as portraying easy access to emergency contraception as an equality issue, would be highly beneficial in this regard. In addition, specific emphasis on the safety of emergency contraception would be extremely valuable, in order to seek to counter the commonly-held myth that use and repeated use of emergency contraception is particularly dangerous in comparison to other drugs. The opportunity for university pharmacy courses to include modules on delivering drugs with the propensity to be be associated with feelings of stigma, with specific emphasis on emergency contraception, must also be considered. With access of emergency contraception often a sensitive issue, it is something for which we feel both pharmacists and other pharmacy professionals should be extremely well- trained and thus we call on the PSI and the IPU for further action on this.
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REMOVING THE CONSCIENTIOUS OBJECTION CLAUSE Under Principle One of the Pharmaceutical Society of Irelands (PSI) Code of Conduct for pharmacists, pharmacists may refuse to dispense the morning after pill if it lies in contradiction with his or her moral standards; if supply to a patient is likely to be affected by the personal moral standards of a pharmacist (PSI, 2013). Though the pharmacist is required to, take reasonable action to ensure those medicines/services are provided and that the patients care is not jeopardised, and the patient is facilitated in accessing the information or service required to meet their needs (PSI, 2013). or, in other words, refer the patient to another pharmacy, this is often physically and financially impossible. Moreover, the term reasonable could be said to be rather vague in nature and open to interpretation by individual pharmacists. Furthermore it is totally unacceptable to turn people away from receiving this legal, safe and often essential drug. A persons decision to access emergency contraception should not be dependent on the value system, religious beliefs or moral philosophy of any other individual.
We believe that this is an extremely vulnerable and degrading position to put any individual in and that it exploits the power and influence of medical professionals. We believe that moral judgements held by medical professionals should not impact on their role in providing patients with safe, legal and requested health care. We believe that patient autonomy must be respected in the highest regard, that our reproductive decisions are our own. 82% of those who responded to our survey agreed that the conscientious objection clause should be removed.
Re(al)-Productive Health thus proposes an amendment to Principle One of the current PSI Code of Conduct. We suggest a replacement of the conscientious objection clause with one which ensures that patients are given this medication on request - irrespective of a pharmacists moral judgements. Indeed, on the basis of interpretation of a number of human rights frameworks, including, for example, the recent ruling in Italy by the Council of Europes Committee of Social Rights finding that, in relation to abortion services, the weak regulation of health personnels conscientious objection violates the right to health
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protection, on the grounds of what appears to be territorial and economic discrimination (IPPF, 2014), as well as a number of others, detailed further within the document, the existence of this conscientious objection clause regarding medication certainly has the potential to be challenged.
Elsewhere
Pharmacists in the UK are also entitled to conscientious objection in the case of providing access to certain drugs, with the General Pharmaceutical Councils Standard of conduct, ethics and performance stating that pharmacists must ensure that; if your religious or moral beliefs prevent you from providing a service, you tell the relevant people or authorities and refer patients and the public to other providers, (GPH, 2012: 10).
Indeed, according to one study the provision of emergency contraception has been shown to be the unprompted ethical issue most frequently mentioned in interviews with UK- based community pharmacists. Similarly, in the USA, a 2010 study indicated that 6% of pharmacists would refuse to dispense prescriptions for EHC on moral grounds with many considering the drug to be a form of abortion (Gallagher et al., 2013: 2).
Should pharmacists not have the right to refuse to provide a drug on the basis of their moral beliefs, like refusing to go to war etc.?
Pharmacists should not have the right to refuse an essential drug, taken autonomously by an informed individual. Gallagher et al., in their article, The fox and the grapes: an Anglo-Irish perspective on conscientious objection to the supply of emergency hormonal contraception without prescription put it very succinctly in their statement; Refusing to do something because your conscience wont allow it may be laudable in some cases, but it stops being laudable when you refuse to accept the consequences of your refusal (Gallagher, 2013: 2). Impeding the freedom of another individual, a freedom which is not harmful to others, based on ones own beliefs is simply not concurrent with any notion of fairness or equality.
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Gallagher et al. also elucidate the relationship between conscientious objection and patient autonomy, a core principle of healthcare in terms of positive and negative obligations on the part of the heathcare provider. In other words; While the negative obligation requires that a patients path to obtaining that which is in the best interests of his or her health is not unnecessarily impeded, the positive obligation calls for respectful treatment in disclosing information and fostering autonomous decision-making (Gallagher, 2013: 2). Any moral objections pharmacist may have regarding the provision of emergency contraception should be thus viewed as contradictory to their very role as a healthcare provider. Indeed, in the UK, Guidance on the Provision of Pharmacy Services Affected by Religious and Moral Beliefs issued in 2010 by the General Pharmaceutical Council appear to reflect such a perspective, with pharmacists now required to tell employers, relevant authorities and colleagues of any religious or moral beliefs affect the provision of pharmacy services to patients and the public. Thus, though technically pharmacists still have the right to conscientiously object, but yet still refer the patient, in the case of EC, to an alternative appropriate source of supply available within the time limits for EHC to be effective (GPH, 2010: 3), as Irish pharmacists do, this requirement to inform potential employers represents perhaps a step in the right direction in terms of making conscientious objection an undesirable, and perhaps eventually unacceptable practice for pharmacists.
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CLARITY ON AGE LIMITS Currently, there exists quite a lack of clarity regarding minimum age requirements for non- prescription levonorgestrel. PSIs guidance currently states that there is no age limit for patients using the product. Nonetheless, it goes on to state that Where a patient is under the age of 16 years it is usual that parental consent is sought, and that Pharmacists should also be aware that the age of sexual consent in Ireland is 17 years (PSI, 2013). Issues surrounding child protection should be acknowledged by pharmacists and pharmacy professionals, and any valid concerns appropriately reported, as is stated in the guidance in the lines pharmacists should consider whether referral to a medical practitioner, other healthcare professional, or other agency or authority, is appropriate (PSI, 2013). Pharmacists are, alongside anyone working or volunteering within the context of children, legally obliged to report child protection concerns in accordance with Childrens First Guidelines.. Such issues would be further covered in the specialised training programmes we propose above. This is something about which Re(al)-Productive Health feels very strongly indeed. Nonetheless, we feel, along with over 91% of our survey respondents, that access to emergency contraception should, essentially, not be limited on the basis of age, and we feel this should be emphasised within the PSI guidelines in order to avoid any misunderstanding with respect to the legality or pharmaceutical consensus regarding providing access to all patients, regardless of age. In terms of safety of the drug, there exists no variation according to age, or lower weight, for example. A host of countries such as the United Kingdom, France, Portugal, Norway, Sweden, Finland, Denmark, Canada, and Israel require no age limit for the use of levonorgestrel over-the-counter, and have reported no adverse outcomes in terms of safety (Rafie et al., 2013: 553). In terms of proper use of the drug, age has also not been found to be a factor. A US study of 345 women using the formerly using the two-pill levonorgestrel option found that age was not associated with appropriate selection of use of levonorgestrel after reading the product labeling (Rafie et al., 2013: 553).
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Furthermore, any incorrect use, i.e. the first tablet taken more than 72 hours after sex or the second tablet taken more than 16 hours after the first was found to be in fact lower among subjects aged 16 years and younger than those aged 17 years and older (Rafie et al., 2013: 553). Indeed, in practice, it would appear that age is a barrier to accessing emergency contraception, with Boots stating that To use the service you need to be over 17 years of age and you will need to present in person to your local Boots pharmacy. It is also useful to note that various other sexually-related items, such as condoms and pregnancy tests, are not limited, either in terms of policy, and most likely, on the basis of age. Emergency contraception should be no different. Thus though, again, pharmacies should be hyper-vigilant regarding issues surrounding potential child protection issues, further clarity within the PSI guidelines regarding the lack of age limits would undoubtedly serve to improve access.
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CLARITY ON GENDER AND SEX At present, there is no strong reference to gender or sex in relation to access of emergency contraception. There appears to be no policy-related barrier in relation to this (i.e. within PSI guidelines). Nonetheless, greater clarity on this is extremely important, for two reasons. Firstly, and most vitally, it is essential that those with the ability to bear children (e.g. trans men, genderqueer and intersex individuals) never be refused access to emergency contraception. Pharmacists, in line with our calls for specialised training, must be aware of and sensitive to the existence and specific needs of all those along the gender and sex spectrum. In addition, it is vital that partners and/or friends should be in a position to access emergency contraception for others - in the case of fear or stigma regarding access, or lack of ability. This call for great clarity within PSI guidelines regarding gender and sex coincides with our calls to remove the mandatory consultation process.
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HUMAN RIGHTS CONTEXT Access to contraception is a human right, protected within many international and European human rights frameworks and doctrines. The ultimate commitment to such a right is perhaps represented by the Convention on the Elimination of all forms of Discrimination Against Women (Article 12), ratified by the Irish state in 1985. In particular CEDAW states that, the role of women in procreation should not be a basis for discrimination (CEDAW, 1979). Indeed, the CEDAW Committee has insisted access to reproductive health to be a basic right under the Convention (Center for Reproductive Rights, 2009), yet have noted that, since its initiation, many countries are in a position whereby while there are no legal barriers, the need for contraception remains unmet (CEDAW Committee, 1999: 56). The 1995 Beijing Platform for Action (Article C:94/95), which the Irish government claims to support, (Department of Justice and Equality, 2002), also constituted a landmark international undertaking regarding womens rights. The Declaration states a commitment to Ensure equal access to and equal treatment of women and men in education and health care and enhance women's sexual and reproductive health. Ireland is also, in an official capacity, a supporter of the United Nations 1994 International Conference on Population and Development (ICPD) Programme of Action, which explains; Reproductive rights embrace certain human rights that are already recognized in national laws, international human rights documents and other consensus documents. These rights rest on the recognition of the basic right of all couples and individuals to decide freely and responsibly the number, spacing and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health. It also includes their right to make decisions concerning reproduction free of discrimination, coercion and violence (ICPD, 1995)
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On the basis of such human rights obligations, Ireland has committed to undertaking the project of Gender Mainstreaming within policy planning and service delivery (The National Womens Council of Ireland, Health Service Executive, 2012: 7). Gender mainstreaming is defined as a; strategic and operational approach to giving visibility to gender inequalities and to addressing the problems entrenched in gender inequalities and unequal social relations. Gender mainstreaming was initially developed through policy and guidance under the United Nations Convention on the Elimination of Discrimination Against Women (CEDAW), the World Health Organisation, the Council of Europe and is a core goal of the European Commissions Strategy on Gender Equality 2010-2014. (The National Womens Council of Ireland, Health Service Executive, 2012: 20). Within the specific context of health, the Health Service Executive (HSE) Gender Mainstreaming Framework, published in 2012, recommends actions that better enable the HSE to deliver its services for women, men and transgender persons and ensure more equal health outcomes for women, men and transgender persons (The National Womens Council of Ireland, Health Service Executive, 2012: 6). While as of yet no strong legislative basis obligates the implementation of gender mainstreaming, such as exists in the UK, with the Equality Duty, as part of the Equality Act of 2010, such actions represent a pivotal element in terms of Irelands duty to respect, protect and fulfill international and European human rights obligations. Furthermore, in terms of drug status, it must be noted that the emergency contraception levonorgestrel is included within the most recent World Health Organisation Model List of Essential Medicines, which includes all those drugs that satisfy the health care needs of the majority of the population which should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford (WHO, 2002: 14).
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Many of the aims outlined within this document can be viewed or embedded within a framework or context of international and European human rights obligations. Certainly, human rights frameworks often provide little substitute for truly transformative, systematic change or, at the very least, fail to be utilised in such a manner. Nonetheless, such instruments can be useful in terms of the application of external pressure upon State bodies. Outlined below is the context of such frameworks in specific relation to our proposals regarding access to emergency contraception in Ireland.
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Cost CEDAW In terms of CEDAW, the CEDAW committee have referred to the subsidisation of contraceptives as an 'obligation under the right to health (Center for Reproductive Rights, 2009), with States obligated to take appropriate legislative, judicial, administrative, budgetary, economic and other measures to the maximum extent of their available resources Committee on the Elimination of Discrimination Against Women, General Recommendation 24: Women and Health (Article 12), 17 (Twentieth session, 1999) ICCPR Cost also appears within the International Covenant on Civil and Political Rights (ICCPR): Article 3 (the right to equality of men and women), Article 6(1) (the right to life), Article 17 (the right to private life), Article 26 (the right to non-discrimination) The body responsible for monitoring state compliance with the ICCPR and interpretation of the Covenant, the Human Rights Committee, has clearly stated effective access to contraception, including through programs addressing financial barriers to contraceptives should be ensured. In addition The Committee on Economic, Social, and Cultural Rights, responsible for monitoring state compliance with ICESCR and interpretation of the Covenant had recommended that contraceptives be available at affordable prices, (Center for Reproductive Rights, 2009: 120) with the highest attainable standard of physical and mental health including sexual and reproductive health, and accessible to all without discrimination especially for the most vulnerable and marginalized. Due to the status of drugs such as emergency contraception within the World Health Organisation Model List of Essential Medicines, the Committee has insisted states should ensure a reliable, continuous stock of high-quality pharmaceutical and contraceptive supplies and equipment (Center for Reproductive Rights, 2009: 121).
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ICPD In addition, as part of the International Conference on Population and Development Programme of Action, States must ensure, as part of their obligations, that reproductive health information, goods, and services are accessible, affordable, acceptable and convenient to all users (UN, 1995: 41) in order for States obligations in terms of respecting, protecting, and fulfilling reproductive rights to be met. Conscientious objection/rota system The issue of conscientious objection is a rather more complex one in terms of human rights obligations. Conscientious objection regarding medical care has been widely debated and contested within the context of international and European human rights and is often presented in quite contradictory terms. At present, no international or European human rights treaties explicitly enshrine a right to conscientious objection. However, freedom of conscience does appear to be protected within some frameworks, such as for example, the European Convention on Human Rights, under Article 9 (1), stating Everyone has the right to freedom of thought, conscience and religion.. This said, however, it is within Article 9 (2) that this is qualified with the affirmation that Freedom to manifest ones religion or beliefs shall be subject only to such limitations as are prescribed by law and are necessary in a democratic society in the interests of public safety, for the protection of public order, health or morals, or for the protection of the rights and freedoms of others (ECHR, 2010: 10). Indeed, in 2010, a report regarding the negative impact of conscientious objection upon reproductive healthcare to the Council of Europe was drafted by Christine McCafferty. However, the response to this report in fact appears to have perhaps strengthened conscientious objection protections. In the Resolution paper, entitled, The right to conscientious objection in lawful medical care, the Parliament emphasises the need to affirm the right of conscientious objection (European Parliament, 2010).
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This said, the Assembly also invites member states of the Council of Europe to develop comprehensive and clear regulations that define and regulate conscientious objection with regard to health and medical services, which...ensure that patients are informed of any conscientious objection in a timely manner and referred to another health-care provider and which ensure that patients receive appropriate treatment, in particular in cases of emergency (European Parliament, 2010). In line with such a sentiment, the CRR, along with The Swedish Association for Sexuality Education also made what is known as a third-party intervention on the basis of a complaint made by the FAFCE (Federation of Catholic Family Associations in Europe) against the Swedish government regarding abortion legislation and the issue of conscientious objection, noting very succinctly that Whereas the freedom of conscience and religion are absolute and non-derogable rights, their manifestation are subject to limitations necessary to protect, among other grounds, health and the rights and freedoms of others (CRR, The Swedish Association for Sexuality Education, 2014: 14). Thus, it would appear that medically-related conscientious objection, within a human rights context, must be subject to certain restrictions and obligations, which would, in theory, ensure women receive the medical services and resources they require. In practice, however, how does this play out? Indeed, the Center for Reproductive Rights and groups within the Sexual Rights Initiative have issued complaints to the U.N. Human Rights Council regarding "unregulated conscientious objection" internationally, stating that States often fail to regulate healthcare providers or hold them to these standards [standards regarding appropriate referral of patients requesting reproductive health services], thus failing in their obligation to protect womens right to be free from violence (CRR, 2013). CEDAW, the only UN treaty monitoring body that has mentioned conscientious objection within the framework of conscientious objection, has noted, on the basis of guaranteeing equal healthcare access between men and women, . . . if health service providers refuse to perform such services based on conscientious objection, measures should be introduced to ensure that women are referred to alternative health providers (CEDAW Committee,
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1999). The European Parliament echoed such insistences in their Resolution on Sexual and Reproductive Health and Rights (2002: 9). Such insistence is indeed reflected within the Irish pharmacy context, within the PSI Code of Conduct, with as previously mentioned, with the an explicit reference to the duty of objecting pharmacists to take reasonable action to ensure those medicines/services are provided and that the patients care is not jeopardised, and the patient is facilitated in accessing the information or service required to meet their needs (PSI, 2013). However, the Irish state has adopted no legally-binding guidelines, such as, for example, our above-detailed proposal regarding Sunday pharmacy rota systems, regarding the necessary considerations or fundamental measures surrounding objection, that would ensure timely access despite objection. Indeed, as decided at the International Conference on Population and Development, reproductive and sexual health services must be physically accessible. In addition, the previously mentioned recent ruling in Italy by the Council of Europes Committee of Social Rights finding that, in relation to abortion services, the weak regulation of health personnels conscientious objection violates the right to health protection, on the grounds of the The right to protection of health, (European Committee on Social Rights, 2014: 2) enshrined within the Covenant which must be free of territorial and economic discrimination (IPPF, 2014) indicates that conscientious objection may also have the capacity to represent a violation of the International Covenant on Economic, Social and Cultural Rights. Much of the above mentioned discussion and contestation however, has largely centred around abortion services. However, conscientious objection within the pharmacy context was highlighted within the case of the application by two pharmacists (Pichon and Sajous v. France, 2001) in France who had been convicted for refusing to sell contraceptives to the European Court of Human Rights. Following the application, the Court considered that as long as the sale of contraceptives is legal and occurs on medical prescription nowhere other than in a pharmacy, the applicants cannot give precedence to their religious beliefs
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and impose them on others as justification for their refusal to sell such products, since they can manifest those beliefs in many ways outside the professional sphere. (ECHR, 2001). Though prescription is no longer required, on the basis of the availability of emergency contraception solely within pharmacies in Ireland, (as opposed to, for example, shops and/or vending machines), this particular case would appear thus, to be the most promising in terms of setting a precedent regarding emergency contraception in Ireland. Indeed, there exists no specific statutory Irish legal reference or indeed international or European human rights reference to the possible validity of conscientious objection in relation to the provision of medicines. Thus, the road to removing the conscientious objection clause within the realm of the pharmacy may not even require recourse to either Irish law or human rights frameworks - it may simply require an alteration to the PSI Code of Conduct. In terms however, of the context of human rights, the overwhelming body of evidence, however, would seem to suggest either the removal of the conscientious objection clause from PSI guidelines (which we would strongly favour), or at the very least, the implementation of regulations in terms of pharmacy access of emergency contraception to be a reasonable and feasible possibility, and one which should be pursued.
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CONCLUSION Improving access to emergency contraception requires focused efforts on all aspects and determinants of access. A society in which all possess full control over their reproductive functions, and indeed their own lives, cannot exist without truly comprehensive access to all essential reproductive resources. We believe the proposals and analysis detailed in this document to be tangible, feasible and reasonable, and we believe the realisation of such goals would serve to go some way towards achieving a semblance of reproductive freedom in Ireland. We must stress, however, that this is by no means our final policy on access to levonorgestrel without prescription in Ireland. We are determined to continue to work with organisations already concerned with health and gender equality - to learn, to exchange ideas. Together, we can seek to continue the fight for reproductive rights for all individuals living in Ireland. RE(AL)-PRODUCTIVE HEALTH, 2014 E-mail: realproductivehealth@gmail.com Website: www.realproductivehealth.com
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References: Bacon et al. (2003) Training and supporting pharmacists to supply progestogen-only emergency contraception. Journal of Family Planning and Reproductive Health Care 29 (2): 17-22 CEDAW Committee (1999) General Recommendation 24 related to Article 12 of the UN Convention on the Elimination of All Forms of Discrimination against Women CEDAW Committee (1999) Concluding Observations to Belize. U.N. Doc. No. A/54/38. CRR (Center for Reproductive Rights) (2009) International Standards on Subsidizing Contraceptives Available at: http://reproductiverights.org/sites/crr.civicactions.net/files/documents/pub_fac_slovak1 _international%20standards_9%2008_WEB.pdf CRR (Center for Reproductive Rights) (2014) their own doc CRR (Center for Reproductive Rights), The Swedish Association for Sexuality Education (2013) Case Document No. 5 Federation of Catholic Family Associations in Europe (FAFCE) v. Sweden. Complaint No. 99/2013. Observations from The Swedish Association for Sexuality Education and the Center for Reproductive Rights (RFSU). European Committee of Social Rights. Department of Justice and Equality (2002) Report to the United Nations on the National Plan for Women 2002 on the implementation of the Beijing Platform for Action. Stationery Office. Ireland. Duggan, B. (2012) Interview with CPC Chairman, Bernard Duggan. IPU Review. July. Irish Pharmacy Union
European Committee on Social Rights (2014) Decision on the Merits: 87/2012 -
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International Planned Parenthood Federation European Network (IPPF EN) v. Italy. Violation of Article 111 (13 against 1). Violation of Article E read in conjunction with Article 11 (13 against 1) ECHR (European Court of Human Rights) (2001) Decision: Pichon and Sajous v. France European Parliament (2002) Resolution on Sexual and Reproductive Health and Rights (2001/2128 (INI)) European Parliament (2010) The right to conscientious objection in lawful medical care. (2010/1763 (INI)) Foster, A., Wynn, L. (2012) Emergency Contraception: The Story of a Global Reproductive Health Technology
GPE (General Pharmaceutical Council) (2013) Standards of conduct, ethics and performance
GPE (General Pharmaceutical Council) (2010) Guidance on the provision of pharmacy services affected by religious and moral beliefs
Grimes, D. (2002) Emergency contraception and fire extinguishers: a prevention paradox. American Journal of Obstetrics and Gynecology 187(6):1536-8
ICEC (2013) Over-the-Counter Access to Emergency Contraceptive Pills. Available at: http://www.cecinfo.org/custom-content/uploads/2013/12/ICEC_OTC_12-17-13.pdf
ICPD (1995) Programme of Action of the International Conference on Population and Development, 7.3, Cairo, Egypt, Sept. 5-13, 1994, U.N. Doc. A/CONF.171/13/Rev.1,
IPPF (2014) Major victory in Europe on International Womens day. International Planned Parenthood Federation, 7 March. Available at: http://www.ippfen.org/news/major-victory-europe-international-womens-day
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Nguyen, A (2005) A Comparative Analysis of Regulated Emergency Contraception vs. Deregulated Emergency Contraception. Wichita State University
The Medical Independent (2010) Boots pharmacists first in Ireland to offer vaccines. 8 July. Available at: http://www.medicalindependent.ie/1239/boots_pharmacists_first_in_ireland_to_offer_vac cines
The National Womens Council of Ireland & Health Service Executive (2012) Equal but Different: A framework for integrating gender equality in Health Service Executive Policy, Planning and Service Delivery Available at: http://www.nwci.ie/download/pdf/equal_but_different_final_report.pdf PCNZ (Pharmaceutical Council of New Zealand) (2013) Best Practice Guidelines for the Supply by Pharmacists of the Emergency Contraceptive Pill
Pharmaceutical Society of Ireland (PSI) (2013) Supply by pharmacists of non-prescription medicinal product containing levonorgestrel (NorLevo 1.5mg tablets) as emergency hormonal contraception
Rafie et al. (2013) Over-the-Counter Access to Emergency Contraception without Age Restriction: An Opinion of the Womens Health Practice and Research Network of the American College of Clinical Pharmacy. Pharmacotherapy 33(5):549-57
UN General Assembly (1979) Convention on the Elimination of all forms of Discrimination against Women
UN (1995) Report of the International Conference on Population and Development.
Vogler et al. (2006) Community Pharmacy in Europe: Lessons from deregulation case studies. Austrian Health Institute
WHO (World Health Organisation). (2002) The Selection and Use of Essential Medicines: Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines)