Privacy Policy | Galafold.com

Our Commitment to Privacy

This Privacy Policy sets out how Amicus together with other members of its group (we/us/our) collect, process and safeguard the personal information you provide to us. It is designed to assist you in making informed decisions when using our Web site and our products and services. This statement will be continuously assessed against new technologies, business practices and our customers’ needs.

By visiting www.galafold.com (Website) or otherwise providing your information to us (either in correspondence, in person or over the phone) you are accepting, and consenting to the practices described in this Privacy Policy.

What Information Do We Collect?

We may collect and process the following personal information about you,:

1) Information you give to us ► Personal information that you provide to us, such as by filling in forms on our Website or when informing us about product safety or quality issues The personal information you give us may include your name, address, other contact details, information concerning health or genetic information.;

2) Our correspondence ► if you contact us, we may keep a record of that correspondence;

3) Website and communication usage ► Website use information collected through cookies and other tracking technologies, including the Internet protocol (“IP”) address used to connect your computer to the Internet, your browser type and version, time zone setting, browser plug-in types and versions, operating system and platform.

How Do We Use the Information That You Provide to Us?

We use your personal information in the following ways:

1) To conduct our business and to provide you goods and services ►  to administer our business and services, including to carry out our obligations arising from any agreements entered into between you and us, which may include passing your data to third parties such as agents or contractors or to our advisors (e.g. legal, financial, business or other advisors);

Use justification:consent, contract performance, legitimate interests (to enable us to perform our obligations and  provide our goods and services to you)

2) To provide you with medical and scientific information and marketing materials ► to provide you with medical and scientific information and for marketing our products and services to you by post, email, phone and fax and, where required by law or regulation, we will ask for your consent to conduct any of these activities. We will provide an option to unsubscribe or opt-out of further communication on any electronic communications sent to you or you may opt out by contacting us as set out below.

Use justification: consent

3) To inform you of changes ►  to notify you about changes to our Website, services and products;

Use justification:legitimate interests (to notify you about changes to our service).

4) To ensure Website content is relevant ► to ensure that content from our Website is presented in the most effective manner for you and for your device, which may include passing your data to business partners, suppliers and/or service providers,;

Use justification: consent, contract performance, legitimate interests (to allow us to provide you with the content and services on the Website)

5) To reorganise or make changes to our business ► In  the event  that  we are (i) subject to negotiations for the sale of our business or part thereof to a third party, (ii) is sold to a third party or (iii) undergo a re-organisation, we may need to transfer some or all of your personal information to the relevant third party (or its advisors) as part of any due diligence process or transferred to that re-organised entity or third party and used for the same purposes as set out in this Privacy Policy or for the purpose of analysing any proposed sale or re-organisation.

Use justification: legitimate interests (in order to allow us to change our business)

6) In connection with legal or regulatory obligations and the directions of law enforcement, regulators and the court service ► We  may process your personal information to comply with our legal or regulatory requirements which may include disclosing your personal information to third parties, the court service, regulators or law enforcement agencies in   connection with enquiries, proceedings or investigations by such parties anywhere in the world or where compelled to do so or in connection with the reporting to such parties of safety information and product quality complaints or to fulfil transparency requirements with respect to transfers of value to you by us. Where permitted, we will direct any such request to you or notify you before responding unless to do so would prejudice the prevention or detection of a crime.

Use justification: legal obligations, public interest, legitimate interests (to cooperate with law enforcement and regulatory authorities), legal claims, medical grounds and public interests

What Are Cookies?

Cookies are a feature of Web browser software that allows Web servers to recognize the computer used to access a Web site. Cookies are small pieces of data that are stored by a user’s Web browser on the user’s hard drive. Cookies can remember what information a user accesses on one Web page to simplify subsequent interactions with that Web site by the same user or to use the information to streamline the user’s transactions on related Web pages. This makes it easier for a user to move from Web page to Web page and to complete commercial transactions over the Internet. Cookies should make your online experience easier and more personalized.

How to manage cookies

You have the ability to accept or decline cookies by modifying the settings in your browser. However, you may not be able to use all the interactive features of our site if cookies are disabled. You may wish to visit www.aboutcookies.org which contains comprehensive information on how to modify the cookie settings on a wide variety of browsers. You will also find details on how to delete cookies from your computer as well as more general information about cookies. For information on how to do this on the browser of your mobile phone or tablet you will need to refer to your device manual.

How Do We Use Information We Collect from Cookies?

We use software tools such as Web server logs to gather information about our Web site users’ browsing activities, in order to constantly improve our Web site and better serve our customers. This information assists us in designing and arranging our Web pages in the most user-friendly manner and to continually improve our Web site to better meet the needs of our customers and prospective customers.

Web server logs allow us to count how many people visit our Web site and evaluate our Web site’s visitor capacity. We do not use these technologies to capture your individual email address or any personally identifying information about you although they do permit us to send focused online banner advertisements or other such responses to you.

How Do We Transmit, Store and Secure Your Personal Data?

Your personal information may be accessed by staff or suppliers in, transferred to and stored at, a location outside the European Economic Area (“EEA”) in which data protection laws may be of a lower standard than in the EEA. Certain countries outside the EEA have been approved by the European Commission as providing essentially equivalent protections to EEA data protection laws and therefore no additional safeguards are required to export personal information to these jurisdictions. In countries which have not had these approvals, (see the full list here http://ec.europa.eu/justice/data-protection/international-transfers/adequacy/index_en.htm). We will either ask for your consent to the transfer or transfer it subject to European Commission approved contractual terms that impose equivalent data protection obligations directly on the recipient unless we are permitted under applicable data protection law to make such transfers without such formalities..

We will take all steps reasonably necessary to ensure that your data is treated securely and in accordance with this Privacy Policy and data protection legal requirements. However, unfortunately, the transmission of information via the Internet is not completely secure. All information you provide to us is stored on secure servers and accessed and used subject to our security policies and standards.

We will retain your personal information for as long as is necessary for the processing purpose(s) for which they were collected and any other permitted linked purpose. So if information is used for two purposes we will retain it until the purpose with the latest period expires; but we will stop using it for the purpose with a shorter period one that period expires. We restrict access to your personal information to those persons who need to use it for the relevant purpose(s). Our retention periods are based on business needs and your information that is no longer needed is either irreversibly anonymised (and the anonymised information may be retained) or securely destroyed.

What About Other third party websites Linked to Our Web Site?

Our Website may contain links to other third party websites which may have their own privacy policies. We do not accept responsibility or liability for the policies or processing of your personal information by websites linked to or from our Website

What are your rights & how to contact us

You have the right to ask us not to process your personal information for marketing purposes. We will inform you if we intend to use your information for such purposes or if we intend to disclose your information to any third party for such purposes. You can exercise your right to prevent such processing by checking certain boxes on the forms we use to collect your personal information. You can also exercise the right at any time by contacting us as set out below.

If you have any questions in relation to our use of your personal information, you should first contact us as set out below. Under certain conditions, you may have the right to require us to:

(a) provide you with further details on the use we make of your information;

(b) provide you with a copy of information that you have provided to us;

(c) update any inaccuracies in the personal information we hold (please see paragraph 5.4);

(d) delete any personal information the we no longer have a lawful ground to use;

(e) where processing is based on consent, to withdraw your consent so that we stop that particular processing (see paragraph 5.1 for marketing);

(f) object to any processing based on the legitimate interests ground unless our reasons for undertaking that processing outweigh any prejudice to your data protection rights; and

(g) restrict how we use your information whilst a complaint is being investigated.

Your exercise of these rights is subject to certain exemptions to safeguard the public interest and our interests. If you exercise any of these rights we will check your entitlement and respond in most cases within a month. If you are not satisfied with our use of your personal information or our response to any exercise of these rights you have the right to complain to the relevant supervisory authority.

We will use reasonable endeavours to ensure that your personal information is accurate. In order to assist us with this, you should notify us of any changes to the personal information that you have provided to us by contacting us as set out below.

Depending on where you are located, the “data controller” of your personal information processed by us under this Privacy Policy will be different. If you have any questions in relation to this Privacy Policy, please contact our Global Data Protection Officer by email at dataprivacyofficer@amicusrx.com.

Our changes to this Privacy Policy

We may change the content of our Website and how we use cookies without notice, and consequently our Privacy Policy may change from time to time in the future. We therefore encourage you to review them when you visit the Website from time to time to stay informed of how we are using personal information.

This Privacy Policy was last updated on May 24, 2018.

INDICATION

Galafold™ is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

The most common adverse reactions reported with Galafold (>10 %) were headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.

USE IN SPECIFIC POPULATIONS

There is insufficient clinical data on Galafold use in pregnant women to inform a drug associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.

It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.

Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.

The safety and effectiveness of Galafold have not been established in pediatric patients.

To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information.