Monday, 5 January 2015

My European roles and NHS-Citizen; Nicola Whitehill

My European roles and NHS-Citizen; Nicola Whitehill
Scleroderma, Raynaud's, Autoimmune Rare Disease. 

#SclerodermaFreeWorld  #RaynaudsFreeWorld  

In the autumn of 1997, I was diagnosed with diffuse systemic sclerosis (ssc) and Raynaud’s, aged 24, and given a 15month prognosis.

Now, at the age of 41, having stabalised my initially very aggressive disease to a manageable level, I feel well enough, to use some of my experience to get involved in any way that I can, to help in the understanding of this rare, life threatening diagnosis.

In the summer of 2014 I attended my first meeting as a patient expert with the European Medicines Agency (EMA).

This was a very exciting day for me, as not only was it the hottest day of the year (thank goodness that I didn’t have to wear my Eskimo outfit, and I was back in my suit), the offices are located at Canary Wharf overlooking the River Thames.

And so, it was quite an adventure to just get there, with me living in the seaside town of Southport, on the north west coast.

However, the location more than compensated for my physical efforts that day. Entry into the building as well as to the meeting room, I can only liken to something similar to that which I have seen in a James Bond movie.

My fellow colleagues made me feel very welcome and at all times, they ensured that I was included in the discussion, often asking me for my view.

The EMA is a decentralised agency of the European Union, responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

It began operating in 1995.

It is the hub of a European medicines network comprising: over 40 national regulatory authorities; the European Commission; the European Parliament; and the World Health Organisation (WHO).

Its aim is to build the best possible regulatory system for medicines for Europe and protect the health of its citizens.

These activities aim to foster the timely exchange of regulatory and scientific expertise, and development of best practices in the regulatory field across the world.

The EMA’s main responsibility is the protection and promotion of public and animal health, though the evaluation and supervision of medicines for human and veterinary use.

The EMA has several further roles which it is responsible for, including Marketing Authorisations, Safety Monitoring, Referrals, Inspections and The Telematics systems exchange information, helping to provide high quality information on medicines to the general public and support the monitoring of the post authorization benefit-risk balance of medicines in the EU.

Most of the EMA’s scientific evaluation work is carried out by its scientific committees, which are made up of members from EEA countries, as well as representatives of patient, consumer and healthcare-professional organisations.

These committees have various tasks related to the development, assessment and supervision of medicines in the EU.

The EMA is also responsible for coordinating the EU’s safety monitoring or ‘pharmacovigilance’ system for medicines.

It constantly monitors the safety of medicines through the EU network and can take action if information indicates that the benefit-risk balance of a medicine has changed since it was authorised.

The EMA’s committees are involved in referral procedures to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines.

In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU.

The matter is the ‘referred’ to the EMA so that it can male a recommendation for a harmonized position across the EU.

The Agency also plays a role in stimulating innovation and research in the pharmaceutical sector:

- it gives scientific advice to companies on the development of new medicines;

- it publishes guidelines on the requirements for the quality, safety and efficacy testing of medicines;

- it provides special assistance to micro, small and medium sized enterprises (SMEs) through its SME office;

- it issues opinions on orphan designation for medicines for rare diseases;

- it manages the Innovation Task Force, a group that provides a forum for early dialogue with applicants.

Scientific Evaluation:

The Agency’s scientific committees are made up of independent professionals nominated by Member States from a pool of over 4,500 European experts.

The committees are responsible for the scientific evaluation of marketing authorisation application dossiers submitted by pharmaceutical companies, as well as for providing opinions on referrals and other issues impacting on public health, at the request of the Member States, the European Commission or the European Parliament.

All committee members are required to make an annual declaration of any direct or indirect interests they have in the pharmaceutical industry.

The Agency publishes these declarations of interest online.  

The EMA has seven scientific committees that carry out its scientific assessments :

- Committee for Medicinal Products for Human Use (CHMP)

- Pharmacovigilance Risk Assessment Committee (PRAC)

- Committee for Medicinal Products for Veterinary Use (CVMP)

- Committee for Orphan Medicinal Products (COMP)

- Committee on Herbal Medicinal Products (HMPC)

- Committee for Advanced Therapies (CAT)

- Paediatric Committee (PDCO)

The work of these committees is supported by Working Parties and other groups.

I am a member of The Committee for Orphan Medicinal Products (COMP).

This is the committee at the EMA that is responsible for reviewing applications from people or companies seeking 'orphan-medicinal-product designation'.

The COMP is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious.  

In the EU, a disease is defined as rare if –

it affects fewer than 5 in 10,000 people across the EU.  

The COMP is also responsible for advising the European Commission on the establishment and development of a policy on orphan medicinal products in the EU, and assists the Commission in drawing up detailed guidelines and liaising internationally on matters relating to orphan medicinal products.

So far I have been involved with several COMP meetings- the majority of which, I have been able to participate in, without having the physical exertion of going to London.

All of the relevant paperwork and documents are forwarded via a secure electronic system network (James Bond style, again), and the meetings can be accessed by teleconference.

This participation arrangement has worked perfectly for me, as my energy, pain and stamina levels are easily exhausted.

This arrangement allows me to be respectful of my symptoms whilst being able to provide an active contribution.

I have found the content of the meetings to be most stimulating, and I am extremely hopeful for the future for newly diagnosed ssc and Raynaud’s patients.

I take huge comfort and encouragement in seeing for myself that the pharmaceutical companies, as well as the leading world ssc experts, are relentless with their research for improving the medicines and treatments for this disease, with the ultimate accolade being to discover the, so far, unknown, cure.   

I have also become an expert with EURORDIS – a non governmental patient driven alliance of patient organisations and individuals active in the field of rare disease, dedicated to improving the quality of life of all people living with rare diseases in Europe.

It is the voice of 30 million people affected by rare diseases throughout Europe.

The mission of EURORDIS is to build a strong European community of patient organisations and people living with rare diseases, to be their voice at the European level, and – directly or indirectly – to fight against the impact of rare diseases on their lives.

So far, I have been able to fulfill my role by engaging from home, using the internet. 

All in all - I would urge ANYone to get involved in any way you can, with anything which will help the experts / new patients, understand this cruel, life- hijacking diagnosis.

There has never been a better time for patients who are practically housebound, to get involved with being active about their disease, and taking some responsibility for their own health, due to the power of the internet.

And here in the UK we have The Equality Act 2010, which stipulates equality for all.

So, all public meetings, legally, should be made available to participants on-line in the event that a person is unable to attend due to their disability.

I am also an active on-line participant with NHS–Citizen, an advisory partner to NHS-England.

I was delighted to have the pleasure of chatting with Simon Stevens (CEO NHS-England) in a chat room, discussing the transfer of medical records between departments, at a recent public meeting.

This was very uplifting for me, as I had been quite upset that I was unable to attend the meeting in person due to my disability.

NHS-Citizen is a forum, which if you have internet access, I would thoroughly recommend you become involved with - to help improve the amazing service which we have here in the UK, our National Health Service (NHS).

I am eternally grateful to the NHS, along with my dedicated medical team, to have kept, and continue to keep, me alive.

In the meantime, I continue to share some of my survival tips and daily coping mechanisms on my blog

This article was written for the Raynaud’s and Scleroderma Association’s Spring Newsletter Jan 2015. 

In 2016, Eurordis published my story on their website here   


#SclerodermaFreeWorld   #RaynaudsFreeWorld   #Research 
#Autoimmune #RareDisease  #LifeChanging

Scleroderma Family Day 2020
25th Anniversary Meeting
The Atrium, Royal Free Hospital, London, NW3 2QG
Chair: Professor Chris Denton

09.30 – 10.00           Registration and Coffee
10.00 – 10.20           Welcome                                                   Dame Carol Black
                                                                Prof Chris Denton & David Abraham
10.20 – 10.40           What is a Biopsy?                                    Dr Kristina Clark
10.40 – 11.05           Dental aspects of Scleroderma            Prof Stephen Porter
11.05 – 11.25           Gastrointestinal problems –                       Dr Fiza Ahmed
shedding new light on old problems 
11.25 – 11.50           Pulmonary hypertension and the heart Dr Gerry Coghlan
11.50 – 12.15           Scleroderma cohort studies –                  Dr Francesco 
                                 ‘Learning from our patients’                     del Galdo
12.15 – 14.15           LUNCH BREAK – see below  
14.15 – 14.45           25 years of progress –                          Prof Chris Denton
from ‘black box’ to ‘positive trials’
14.45 – 15.15           International speaker –                            Dr Madelon Vonk
                                 Scleroderma Management in Netherlands
15.30                        Raffle
Lunchtime Discussions Groups / Demonstrations include:
Clinical Trials                                                                  Rachel Ochiel and team
National Institute of Health Research                            Christine Menzies
Drug Information / monitoring                                        Pharmacy
Massage                                                                         Keith Hunt MBE
Pulmonary Hypertension Education / nursing            Sally Reddecliffe/Adele Dawson
Rheumatology Laboratory                                          Research Laboratory Staff
Scleroderma Education / Nursing                          Louise Parker/ Joseph Cainap
Thermography                                                                Dr Kevin Howell
SRUK                                                                             Ollie Scott
Sjogren’s syndrome                                                       British Sjogren’s Society  

To Read My Articles:  

Gift in My Will, Click here 

Planning for the Future, Click here  


Rare Disease Day:   

Rare Disease Day 2020:  


Listen to my interview with John Smeeton, (Silver Fox), from the Royal Free Radio, here   

Raise awareness and donate to medical research, order your #SclerodermaFreeWorld #RaynaudsFreeWorld tshirt  here   
Rare Disease Day 2020: NIHR 'Research gives hope to Rare Disease patients', Click here  



Rare Disease Day 2019: Leaving a Legacy Gift, Click here        

Rare Disease Day 2019: 11am 97.4RockFM headlines, NO CURE, Click here    

Rare Disease Day 2018 – Research, Taking Part in Clinical Trials. Scleroderma, Raynaud's, Autoimmune Rare Disease, Click here     

2017 Rare Disease Day Medical Research  

2016 Rare Disease Day Patient Voice   

2016 Rare Disease UK Parliamentary Reception       

Rare Disease Day is a fantastic opportunity for the entire rare disease community to shine a spotlight on their reality, combining as one unified voice. Where, at least one commonality presides –  
Medical Research
provides the brightest light,
for the illumination of
the rare disease patients’ plight.

To read about medical research at the scleroderma unit, Click here   

Although rare disease patients are few in number, eg. 2.5 million scleroderma patients worldwide, (the World Scleroderma Foundation), the commonalities and golden hallmark for each rare disease patient are the same overall. 

For optimum patient care, 3 hallmarks preside:

supported by a medicaldream team’ 
(expert specialist as the clinical lead).



To read my articles:  

Celebrating 20 years of being a patient at the Scleroderma Unit, Click here

2019 New Challenges, Click here
NIHR Video: 'My Experience of Clinical Trials', Click here 

If we only had more RESEARCH investment for Scleroderma, Raynaud's, Autoimmune Rare Disease, Click here   

The Importance of Medical Research and Awareness to the Scleroderma, Raynaud's, Autoimmune Rare Disease patient, Click here  

2018 Scleroderma Awareness Raising and Medical Research, Click here    


Importance of an early diagnosis, Click here   
Taking Part in Clinical Research Trials, Click here     

The Importance of a Multi Disciplinary Medical ‘Dream Team’, Click here    

Expert Specialist Centres, Click here      
My Skin is Cured from Scleroderma, Click here   
UK Guidelines for Managing and Treating Scleroderma, Click here        

Fatigue, Click here         

Mobility, Click here      

Diet and nutrition, Click here      

Raynaud's- How to Diagnose, Click here        

'All you need to know', 2016 Awareness Video, Click here    

Global Patient Profiles 2018 Video, Click here    

Unmet Medical Needs, Click here     

Calcinosis Video, Click here    

The scleroderma tooth fairy, Click here     

Skin Cancer and scleroderma, Click here   


Sept 2017

Prof Chris Denton and I, Sept 2017

June 2019

This year, 2020, I am celebrating 22 years of being a patient at the Scleroderma Unit, The Royal Free Hospital - a world leading expert specialist, research centre.  

Read more, here.    

I am eternally grateful to the global scleroderma trail blazers Dame Prof Black and Prof Chris Denton, whose commitment and dedication to unlocking the scleroderma enigma, is nothing other than, superhuman. Along with the Raynaud's world trail blazer, Dr Kevin Howell.  

I am truly humbled and inspired by their work ethic and commitment to their patients.  

I am wholly appreciative for Prof Denton’s continued medical expertise and support, especially during my barrister qualifying years, 1997 - 2004. 
1st March 2004, I qualified as a self employed practising barrister. Further to having been told in 1997, by my original diagnosing doctor, that I was looking at a 15month prognosis. 


Chat Magazine May 2019
I very much hope to utilise my professional skills and qualifications along with my patient experience, to help achieve the #SclerodermaFreeWorld dream, hoping to improve understanding and best practice, in the meantime. Read more, here    


World Scleroderma Day 2018, Click here  

World Scleroderma Day 2017, 29th June, Click here    

World Scleroderma Day 2016, 29th June. Origins of the date, Click here   

World Scleroderma Day 2015, 29th June.  

James Carver, myself, Prof Chris Denton

I had the pleasure of being a presenter and part of the European co-hort who gave a presentation at the European Parliament, Brussels, in honour of World Scleroderma Day 2015.  

I am immensely grateful to James Carver, former MEP, for organizing this event in memory of his late wife Carmen, who sadly passed from Scleroderma.  

To view the presentation, Click here   


Raynaud's, Click here  
To view the UK treatment guidelines for Raynaud’s Phenomenon, Click here   

To view the EULAR treatment guidelines, Click here   

To view Thermograph Video, Click here    

To view Thermograph image, Click here    

My Raynaud’s reality, Click here     

The global Raynaud's trailblazer - Dr Howell and I, Sept 2017

To view Nailfold Capillaroscopy equipment (used to identify possible blood vessel damage), Click here   

Invisible Disability Awareness Video, Click here 

To read My ‘Invisible Disability’ experience, Click here   

50 Shades of Blue, Click here


For latest updates follow / subscribe:  



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#SclerodermaFreeWorld           #RaynaudsFreeWorld    #Research  

Please DONATE to help fund medical research at The Scleroderma Unit,The Royal Free Hospital, London.  

Alternatively, to make a direct donation to fund medical research via the Royal Free Charity, Scleroderma Unit, Click here    

100% of your monies will be used for medical research purposes only. NO wages or admin costs. Thank You. 


Last Update: Feb 2020.       

My European roles and NHS-Citizen; Nicola Whitehill
Scleroderma, Raynaud's, Autoimmune Rare Disease. 

#SclerodermaFreeWorld  #RaynaudsFreeWorld  


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