Emergency : Contraception in Ireland

Improving access to non-prescription emergency contraception in Ireland






Re(al)-Productive Health




2



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.


















3

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


4


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, it’s 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.





5


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.














6


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













7



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 didn’t 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 people’s right to contraception.





8


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.


9

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 doctor’s 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.



10

Wouldn’t 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 individual’s choice to access the morning after pill, once that
decision is the individual’s 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 individual’s 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.
Don’t 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 person’s 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.


11











12

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 wasn’t an idiot
and I just made a stupid mistake, and why wasn’t 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.



13

According to the recently updated, (December 2013), PSI (Pharmaceutical Society of
Ireland) guidance on the supply of levonorgestrel NorLevo by pharmacists, the ‘supply of
Norlevo®1.5mg 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 pharmacy’s patient consultation area’ (PSI, 2013).

Boots were the first chain of pharmacies to provide Norlevo without a doctor’s
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 doctor’s
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’,


14

‘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 ‘Vick’s NyQuil’) (Rafie et al., 2013: 553).
Indeed, we would agree with the International Consortium for Emergency Contraception’s
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,


15

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.






16

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
Board’s 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


17

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 pharmacist’s 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 pharmacist’s 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


18

take place in the pharmacy’s 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 patient’s. 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



19

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).





20















21

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 O’Keefe
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
one’s 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.






22

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.






23

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).












24

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,


25

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.




26

REMOVING THE CONSCIENTIOUS OBJECTION CLAUSE
Under Principle One of the Pharmaceutical Society of Ireland’s (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 patient’s 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 person’s 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
pharmacist’s 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 Europe’s Committee of Social Rights finding that, in relation to abortion services, the
‘weak regulation of health personnel’s conscientious objection violates the right to health


27

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 Council’s 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 won’t 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 one’s own beliefs is simply not concurrent with any notion of fairness or equality.


28

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 patient’s 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.











29

















30

CLARITY ON AGE LIMITS
Currently, there exists quite a lack of clarity regarding minimum age requirements for non-
prescription levonorgestrel. PSI’s 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 Children’s 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).


31

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.











32

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.










33

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 women’s 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)



34

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 Women’s 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 Nation’s 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
Commission’s Strategy on Gender Equality 2010-2014. ‘ (The National Women’s 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 Women’s
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 Ireland’s 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).


35

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.















36

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).



37

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 one’s 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).



38

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
women’s 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,


39

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 patient’s 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 Europe’s
Committee of Social Rights finding that, in relation to abortion services, the ‘weak
regulation of health personnel’s 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


40

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.









41

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








42

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 -


43

International Planned Parenthood Federation – European Network (IPPF EN) v. Italy.
Violation of Article 11§1 (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 Women’s day’. International
Planned Parenthood Federation, 7 March. Available at:
http://www.ippfen.org/news/major-victory-europe-international-women’s-day



44


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 Women’s 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 Women’s 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)





45














Master your semester with Scribd & The New York Times

Special offer for students: Only $4.99/month.

Master your semester with Scribd & The New York Times

Cancel anytime.